The Pharma Legal Handbook: Romania

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The Pharma Legal Handbook: Romania answers essential questions about the legal and regulatory environment for pharmaceuticals in Romania. It is a must-have for any company operating in the country or looking to enter the market.

Prepared in association with Mușat & Asociații, one of the leading law firms in Romania, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks, patents, cannabinoid drugs, medical cannabis and opioids.

If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.

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June 2019

1. Expenditure Control & Cost Containment Policies in Romanian Pharma

Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359.

1. Please describe the main cost containment policies in place in your country and their fundamental principles

a. Pricing and impact of generic/biosimilar approval

The price of off-patent innovative medicines cannot exceed, as a rule:

the level of the innovative reference price (computed according to a special 65% reference rule, depending on the patent expiry date and on the presence of generic alternatives on the market); or,
as the case may be, the level of the innovative reference price (computed according to a special 80% reference rule, depending on the patent expiry date and on the presence of biosimilar alternatives on the market).

b. Clawback/Payback/Discounts/Rebates

As a rule, the marketing authorisation holders and their legal representatives should pay on a quarterly basis the clawback tax for the medicines traded on the Romanian market; certain medicines are exempted from the payment of the clawback tax.

The marketing authorisation holders should pay the payback tax for the medicines which are reimbursed in Romanian based on a cost volume agreement.

NHIH could conclude additional protocols with pharmaceutical companies concerning special discounts or rebates for medicines.

c. Existence of Price/Volume agreements in the frame of public tendering

N/A

d. Existence of price freezes and cuts

Price freezes

The Romanian legislation in force provides for the possibility of the Ministry of Health to freeze the prices of medicinal products.

By law, in the case of a price freeze, imposed on all medicines or only a category of medicines, the Ministry of Health carries out an analysis at least once a year to determine whether the macroeconomic conditions require maintaining the freeze.

Within 90 days from the beginning of this analysis, the Ministry of Health should announce price increases or decreases, if any.

Exceptionally, marketing authorisation holders can ask for a derogation from the price freeze, for specific reasons.

Price cuts

The Romanian legislation in force provides for the possibility of the Ministry of Health to reduce the prices of medicinal products.

The Ministry of Health could request the reduction of the CANAMED manufacturer price, e.g., if the Ministry of Health or NAMMD find out that the marketing authorisation holder could supply the medicines in Romania at a level below the CANAMED manufacturer price.

e. Post-launch monitoring of prescriptions/sales

Post-launch monitoring of prescriptions/sales is quite abundantly regulated by the Romanian legislation which expressly provides for reporting obligations for several relevant actors, as follows:

i. wholesale distributors/importers/manufacturers should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including distribution outside the territory of Romania, carried out with medicines for human use from their own portfolio having the price approved in the CANAMED;
Also, wholesale distributors/importers/manufacturers should report to NAMMD, at the end of each calendar month, the situation regarding commercial operations, including parallel import, respectively the distribution of medicines outside the territory of Romania, in other states from the European Economic Area, carried out with medicines for human use from their own portfolio;

ii. closed and open circuit pharmacies should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including the release on consignment, as the case may be, for medicines having the price approved in the CANAMED;

iii. hospitals and dialysis centers should report monthly to the health insurance houses, the consumption of medicines, for the purposes of the computation of the clawback/payback contribution;

iv. open-circuit pharmacies report the monthly consumption of medicines, under the terms of the framework contract that regulates the conditions for providing medical assistance within the social health insurance system, for the purposes of the computation of the clawback/payback contribution.

The reporting provided under items (iii) and (iv) above is also made electronically, by using the SIUI (a specially designed program/system).

f. Existence of Generic Substitution Policies

In Romania, there were several initiatives for setting the cases in which a generic substitution is possible.

i. At prescriber level

Medicinal products with or without personal contribution reimbursed in the national health insurance system should be prescribed by physicians who are in contractual relationship with the health insurance houses.

As a rule, the physicians should prescribe the medicinal products by mentioning the relevant international non-proprietary name (INN) on the prescription. However, in medically justified cases and in case of biological products, the physicians could also mention on the prescription the relevant trade name of the prescribed products.

ii. At retail level

The patients will acquire the reimbursed medicinal products by presenting the prescriptions to the suppliers of medicinal products (e.g., pharmacies) which are in contractual relationship with the health insurance houses.

Unless the physician recommends a certain brand (trade) name, the pharmacist’s recommendation regarding the trade names corresponding to the INN prescribed by the physician should be in the ascending order of the price, starting with the cheapest medicinal product with the respective non-proprietary name (INN).

2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc)?

The Romanian legislation does not expressly regulate other policies in place aiming at cost control via incentive programs.

Also from this Legal Handbook

2. Biosimilars and Biologics: Romania

The ins and outs of biosimilars and biologics in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. Are biosimilar medicines considered the same as generic medicines in your country?

The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates biosimilars and generics in a different manner.

As per the local legislation, a biosimilar is a biologic medicinal product similar to another already authorised biologic medicinal product, referred to as the biologic reference medicine. Thus, the biosimilar is not identical to its reference product.

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

According to the Romanian Patent Law, in order to be subject matter of a patent, biotechnological inventions have to first comply with the general conditions of a patentable invention. There are no specific exceptions provided by the Patent Law concerning the patentability of biologic or biosimilar medicines.

However, in the biotechnology field, the Patent Law draws the limits of patentability of biotechnological inventions, by indicating which inventions are patentable and by providing a list of exceptions thereto. Therefore, inventions that concern a product consisting or containing biological material or a process by means of which biological material is produced, processed or used, to be patentable should:

be new, involve an inventive step and susceptible of industrial application;
refer to one of the specific subject matters established by the legal provisions:

1. biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature;
2. plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;
3. microbiological or other technical process or a product, other than a plant or animal variety, obtained by means of such a process;
4. an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, even if the structure of that element is identical to that of a natural element;

3. not be excepted from patentability by the Patent Law, as follows:

1. the human body in various stages of its formation and development, as well as the mere discovery of one of its elements including the sequence or a partial sequence of a gene;
2. processes for cloning human beings;
3. processes for modifying the germ line genetic identity of human beings;
4. uses of human embryos for industrial or commercial purposes, assuming that they do not have a therapeutic or diagnostic purpose applied to the human embryo, if useful for the same;
5. processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
6. plant and animal varieties.
7. essentially biological processes for the production of plants or animals.

Hence, provided that the above provisions are observed, starting from the general conditions (i.e., being novel, having an inventive step and being capable of industrial application), to the specific ones, biologic or biosimilar medicines may be subject to patentable inventions, both for product and for process inventions.

If in case of biological innovative medicinal products the patentability can be more easily established, the biosimilar medicinal products might require a clarification in this respect, taking into consideration that they are highly similar to another already approved biological medicine and require comprehensive comparability studies with the reference biological medicine. Such similarity between the biosimilar product and the reference one does not remove ab initio the novelty and the inventive step of the biosimilar. Even if the latter one is a subsequent version of an existing biologic drug, however it is not an exact copy of the reference medicine, and there might be cases when the biosimilar medicine can fulfil the conditions of patentability even for a product invention, not only for a process invention. Only if the claims for the biosimilar medicine invention are not found in the state of the art, meaning they exceed the protection granted for the reference biological medicine, the protection conferred by a patent for such biosimilar medicine could be granted, irrespective if the protection is for the product itself or for a process regarding such product.

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

As a rule, the marketing authorisation of the biosimilar medicines should be approved by the European Medicines Agency at centralized level.

The Romanian legislation does not provide for a specific regulatory framework for the marketing authorization of biosimilar medicines at the national level.

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The authorisation of biosimilars products in the EU requires a different set of data compared to other biologicals. In the case of biosimilars, applicants should provide a special data package proving the high similarity with the reference product. Such a data package is obtained by performing a biosimilar comparability exercise.

The Romanian Health Law mentions the need to submit the results of appropriate pre-clinical tests or clinical trials when a biological medicinal product does not meet the conditions to be qualified as a generic medicine. The differences between the biological reference medicine and the biosimilar could relate to raw materials, manufacturing processes, etc. However, the results of other tests and trials from the reference medicinal product’s dossier should not be provided.

5. What are the requirements for the choice of the reference comparator product?

As per the European Medicine Agency’s Guidelines on similar biological medicinal products, the reference medicinal product should be a medicinal product authorized in the EU, based on a complete dossier in accordance with Directive 2001/83/EC on medicinal products for human use.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

In principle, the reference medicinal product used as a comparator should be a medicinal product authorised in the EEA. However, it is also possible for the applicant to compare the biosimilar with a non-EEA authorised comparator (i.e., a non-EEA authorised version of the biological reference medicinal product), authorised by a regulatory authority with similar scientific and regulatory standards as the EMA.

In this respect, European Medicine Agency’s guidelines mention that if certain clinical and in vivo non-clinical studies are performed with the non-EEA authorised comparator, the applicant for the marketing authorisation should provide adequate data or information to scientifically justify the relevance of these comparative data and establish an acceptable connection with the EEA-authorised reference product.

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

The prices of biosimilar medicines should be approved by the Ministry of Health, based on the application dossier submitted by the marketing authorisation holders or their representative. As a rule, the price proposed by the applicant for a medicinal product should be lower than or equal to the prices of the same medicine in the 12 (twelve) reference countries mentioned under section 9 above (i.e., Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany).

The pricing norms provide for different rules for reference (original) biological medicines and for the biosimilar medicines, as follows:

from a pricing perspective, the reference (original) biological medicines are assimilated to innovative medicines;
as a rule, the price of biosimilars medicines should not exceed the biosimilar reference price (BRP), computed at the level of 80% of the price of the original biological medicine;

It is noteworthy that this rule applicable to biosimilars is more favourable than the pricing rule applicable to generic medicines. Thus, the price of generics should not exceed the generic reference price (GRP), representing 65% of the price of the innovative product.

The latest amendments to the pricing legislation in Romania provide for an exception to the rule of proposing the price for the biosimilar medicines by reference to the biosimilar reference price, if a medicinal product is the only medicine having the respective INN, strength and pharmaceutical form included in the CANAMED national price catalogue.

In such cases, the price proposed to the Ministry of Health does not have to be compared to the biosimilar reference price, but only to the price in the 12 reference countries.

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

The national legislation contains special rules providing for the reimbursement and prescribing of biosimilars, as follows:

there are special criteria for the health technology assessment of biosimilars performed by the National Agency of Medicines and Medical Devices in order to evaluate if the product could be included in the national list of reimbursed medicines;
while the general rule is that the medicines should be prescribed by mentioning their international non-proprietary name (and not the trade name) on the medical prescription, the attending physicians are entitled to prescribe biological medicines, including biosimilars, by mentioning their trade name on the prescription;
(medicines suppliers, namely open-circuit pharmacies which have concluded agreements with health insurance houses for the supply of medicines and medical supplies granted for the out-patient treatment of patients included in certain national health programs within the social health insurance system, are required not to replace a biological with its biosimilar, without the physician’s recommendation.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Yes, if a biosimilar product is placed on the Romanian market and becomes reimbursed in the Romanian health insurance system, this will impact the reimbursement of the originator reference product. Amongst others, the reimbursement price of the originator reference product (i.e., the value reimbursed by the National Health Insurance House) will be reduced

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

The national legislation does not expressly provide for special requirements for prescribing and dispensing biosimilar medicinal products, except that the biosimilars and the original biological medicines could be prescribed by mentioning their trade name on the prescription. The general rule, applicable to all other medicines, is that the prescription should only mention the product’s international non-proprietary name (INN) and not the trade name, and that the pharmacy could dispense any medicine having the respective INN.

Otherwise, the biological medicines (originals or biosimilars) could be released to patients by open-circuit pharmacies or by hospitals (closed-circuit pharmacies), depending on the prescription requirements and the therapeutic protocols applicable to each product.

There are no differences between the original biologics and the biosimilars, as regards the prescription and the dispensing to patients.

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

The process of replacing one medicine for another one known to have the same clinical effect (e.g., replacing a biological reference with a biosimilar or vice-versa or replacing a biosimilar with another) is known as interchangeability. Interchangeability can be performed either by:

switching – the process of replacing one medicinal product with another, performed by the prescribing physician; or
automatic substitution – the process of dispensing another medicinal product instead of the one mentioned in the medical prescription, performed at pharmacy level by the pharmacist, without consulting the prescribing physician.

According to the recommendations at European level, the decision on whether to allow interchangeable use of such medicinal products belongs to each EU Member state.

In this respect, the Romanian legislation mentions that switching from a biological reference medicinal product to a biosimilar medicinal product (or from a biosimilar to another one) should be decided only by the physician.

Moreover, the national reimbursement legislation provides for the obligation of pharmacists to dispense biologicals (including biosimilars) having the exact trade name provided for in the medical prescription. The automatic substitution of biologicals (including biosimilars) at pharmacy level, without the physician’s approval, is expressly prohibited.

12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

The legislation does not expressly provide for a special pharmacovigilance system for biosimilar medicinal products, hence they are subject to the same pharmacovigilance requirements as all biologicals.

However, note should be made that the applicant for a marketing authorisation intended for a biosimilar should include in the application a description of the pharmacovigilance system as part of a risk management plan due to be implemented for the respective medicinal product.

As for the post-authorisation requirements, applicants/marketing authorization holders should take into account the following obligations:

the potential obligation to carry out post-authorization safety studies; if such studies have been requested for a reference medicinal product, they shall be generally requested for its biosimilar as well;
the obligation to submit with the regulatory authorities periodic safety update reports;
the obligation to ensure product traceability; in this respect, it is essential to identify the product with the trade name or INN, as well as the name of the marketing authorization holder, and batch number of the product administered; for this exact reason biological medicines shall be prescribed by physicians by their trade name and not by their INN;
the obligation to ensure a monitoring system specially designated for biologicals; such monitoring system is called “additional monitoring” and biologicals are hence included on a list of medicinal products under “additional monitoring”; the list includes products authorized in the EU which are closely monitored by the regulatory authorities (due to the fact that their active substance is new on the market or due to the limited data on its long-term use) and which are labelled with a black triangle on their package insert, along with the sentence “This medicinal product is subject to additional monitoring”.
the obligation to monitor immunogenicity, in order to analyze rare immune reactions which can only be detected after a long follow-up period in larger numbers of patients.

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

The labelling of biosimilars follows the general legal framework providing for the labelling of medicinal products.

Additionally, it is mandatory that the biosimilar’s label does not infringe the intellectual property rights of the original biological product.

In this respect, EMA’s procedural advice for users of the centralized procedure for similar biological medicinal products applications refers to the “skinny labeling” of biosimilars, which means that information directly related to a patented therapeutic indication should be deleted from the following sections: therapeutic indications, posology and method administration and pharmacodynamics properties of the summary of product characteristics.

From a reimbursement perspective, by way of example, if the biosimilar will first be included only in certain sub-lists of the INN Reimbursement List (i.e., only for certain therapeutic indications), it could apply at a later stage (e.g., once it becomes free to enter the market with full label) for the reimbursement of the remaining indications.

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

According to the latest information published by the Ministry of Health in 2022 there are more than 100 biological medicines authorised for marketing in Romania, whose price was approved by the Ministry of Health. These medicines are included in the national price catalogue, and part of them are reimbursed in the national health insurance system and in the national health programs. .

From an IP standpoint, in the last years, there were several disputes regarding the adequate labelling and promotion in Romania. The manufacturers of original biologics stressed that the biosimilars should be labelled, promoted, reimbursed, sold and acquired without breaching the intellectual property rights of the originals and that the requirements concerning “skinny labelling” should be observed.

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

The healthcare authorities announced their intention to amend the legislation for encouraging the market access of biosimilars, since this will bring significant cost savings for the national health insurance system. However, it is difficult to anticipate when these changes will be introduced in the legislation.

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Also from this Legal Handbook

3. Localization: Romania

The ins and outs of localization in Romanian pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

Romania has a favourable tax regime for companies, which encourages many businesses to set up and to operate subsidiaries in Romania. However, there are no special rules or additional benefits for the localization of pharmaceutical companies.

In this context, numerous international pharmaceutical companies decided to set up marketing affiliates in Romania and many of them set up local distribution affiliates, duly authorised for the wholesale distribution of medicinal products. The number of pharmaceutical companies which hold manufacturing facilities in Romania is rather low.

Also, it is noteworthy that the import of medicinal products into Romania is allowed only based on an import authorisation issued by the National Agency of Medicines and Medical Devices. Hence, the non-resident pharmaceutical companies which export medicines to Romania need to have a local distribution partner or, alternatively, set up a local distribution affiliate which will import the medicines in question.

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

There have been no recent changes in Romania providing for localization rules and policies applicable to pharmaceutical companies.

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

According to the in-force legislation, the process of obtaining a marketing authorization is not impacted by localization policies.

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The pricing process for pharmaceutical products is not impacted by localization policies.

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The reimbursement of pharmaceutical products is not impacted by localization policies.

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The applicable legislation does not expressly provide that the access of pharmaceutical products to public tenders is impacted by localization policies.

However, in practice, the contracting authorities organizing public procurement procedures for medicines (e.g., the public hospitals) could provide for special requirements in the tender documentation which would require the procurement of medicines by local distributors.

The regulatory authorities also consider that the sale of the medicines to the Romanian hospitals and pharmacies should be performed by a local distributor authorised by the National Agency of Medicines and Medical Devices for the wholesale distribution of medicinal products.

Accordingly, localization policies could impact the public procurement procedures for pharmaceutical products and the supply of the medicines to the local hospitals and pharmacies.

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

For the moment, no specific localization policies have impacted the tax rates applicable in Romania with respect to pharmaceutical products. As a general rule, the tax legislation establishes different taxation rules depending on the tax residency of the beneficiary of income. As such, resident entities that are corporate income taxpayers may benefit from certain profit tax exemptions or incentives (e.g. special deductions for research and development, tax exemptions for reinvested profits etc.).

Separately, as regards the customs legislation, the EU general rules regarding the preferential origin of products (for benefiting from reduced import rates based on trade agreements concluded by the EU with third countries), anti-dumping rules or specific import restrictions (e.g., import restrictions for products originating from certain countries) may apply. In addition, attention should be paid to the EU rules regarding the imports of medicinal products. For example, in case of importing medicinal products for veterinary and/or human use (with certain exceptions) the following requirements apply:

Import authorization – it is required to obtain an import authorisation;
Marketing authorization – Medicinal products may only be placed on the EU market when a marketing authorization has been issued by the competent authorities of a Member State or by the European Medicines Agency (EMEA). This authorization is granted only to applicants established in the EU. Through the EEA Agreement this is extended to include also Norway, Iceland and Liechtenstein. UK’s withdrawal due to Brexit will also have an impact on the placement of medicinal products, since the marketing authorization may be obtained only by applicants established in the EU, and many pharmaceutical companies transferred their marketing authorisations from UK entities to entities located in EU countries.
Labelling and packaging provisions – as a rule, the label and the packaging should be drafted in Romanian language;
Control of each batch; and
The need to implement an EU and a national pharmacovigilance system.

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

There are no other incentives or advantages offered by localization rules in Romania.

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

There is currently no discussion about new localization policies in Romania.

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Also from this Legal Handbook

4. Orphan Drugs and Rare Diseases: Romania

All legal aspects surrounding the orphan drugs and rare diseases in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What is the definition of Rare Diseases in your country?

Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European Medicines Agency as an orphan medicine when:

(i) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the Community when the application is made; or
it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment; and

(ii) there is no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

The Romanian legislation on the health technology assessment (HTA) of medicinal products provides for the definition of rare diseases, in the context of evaluating the medicines in view of their inclusion in the national reimbursement list.

According to the HTA legislation, rare diseases are conditions which are affecting not more than 5 in 10,000 persons in the European Union or which are life-threatening, chronic debilitating or serious and chronic conditions of the body.

The Government created a national health insurance program for rare diseases, which provides for the treatment of patients diagnosed, amongst others, with degenerative / inflammatory-immune neurological diseases, imperfect osteogenesis, Fabry disease, Pompe disease, tyrosinemia, Mucopolysaccharidosis type II (Hunter syndrome), Mucopolysaccharidosis type I (Hurler syndrome), congenital afibrinogenemia, primary immunodeficiency syndrome, bullous epidermolysis, systemic sclerosis, evolving digital ulcers, amyotrophic lateral sclerosis, cystic fibrosis, Prader Willi syndrome, idiopathic pulmonary fibrosis, Duchenne muscular dystrophy, hereditary angioedema and Leber hereditary optic neuropathy.

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Pursuant to the national legislation, the designation of a medicine as an orphan drug should be performed by the European Medicines Agency in accordance with Regulation no. 141/2000.

The definition of “orphan medicines” does not correspond with the definition of “rare diseases”, because the rare diseases could be treated also with certain medicines which do not have an orphan designation. In this respect, the HTA legislation provides that an INN could fall under the “orphan” or the “rare disease” categories, as follows:

INNs with orphan status, designated as such by the European Medicines Agency; or
INNs for rare diseases, whose orphan designation was removed by the European Medicines Agency or which did not have an orphan designation, used for the treatment, prevention or diagnosis of certain conditions which are affecting not more than 5 in 10,000 persons in the European Union or which are life-threatening, chronic debilitating or serious and chronic conditions of the body.

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The Romanian legislation specifies that the authorisation and designation of a medicinal product as orphan drug should be performed at the EU centralized level, and not at a national level.

The European Medicines Agency is the main authority in this field, responsible for the scientific evaluation of marketing authorisation applications for orphan medicines under the EU centralised authorisation procedure. If a medicine has an orphan drug status at the EU centralized level, this status will be acknowledged by the Romanian authorities.

The authorisation and the designation of orphan medicines should be carried out in accordance with Regulation no. 141/2000 and Regulation (EC) no. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (the „Regulation no. 726/2004”).

The EU procedure for the designation of an orphan medicine involves, amongst others, the filing of an application dossier with the European Medicines Agency and the issuance of on opinion by the Agency’s Committee for Orphan Medicinal Products, based on which the European Commission will adopt its decision. The designated medicine will be included in the Community Register of Orphan Medicinal Products. The marketing authorisation for these medicines should be issued afterwards by the European Medicines Agency.

While the Romanian authorities do not approve the orphan drug status, they could acknowledge the rare disease status under the HTA procedure and/or in the national health programs.

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

The Romanian legislation does not provide for relaxed clinical trial/scientific evidence requirements in respect of orphan medicinal products. The matters pertaining to the marketing authorisation of orphan drugs should be handled by the European Medicines Agency, in accordance with the EU legislation.

In this respect is it noteworthy that according to Regulation no. 141/2000, the sponsor of an orphan medicine could request advice from the EMA on the conduct of the various tests and trials intended to demonstrate the quality, safety and efficacy of the respective medicinal product, before filing the marketing authorization application for the product in question.

5. Is there an expedited pathway for Orphan Drugs?

According to the EU legislation, the medicines authorised at centralized level, including orphan drugs, could undergo an accelerated assessment if they are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation.

The European Medicines Agency could perform such accelerated assessment in accordance with EU Regulation no. 726/2004. The authorisation timeframe would be reduced from 210 days to 150 days as of the filing of a valid application.

The Romanian legislation does not provide for an expedited pathway for the marketing authorisation of orphan medicines at national level, since such authorisation is granted by the European Medicines Agency at the EU centralized level.

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

As a rule, in order to be placed on the Romanian market, medicinal products should have a marketing authorisation issued by the National Agency of Medicines and Medical Devices at national level or by the European Medicines Agency at centralized level.

In case of orphan drugs, the marketing authorisation issued by the European Medicines Agency at EU centralized level is recognized in Romania. The marketing authorisation for orphan medicines issued by other countries are not recognized at local level.

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

Medicinal products could be reimbursed in the Romanian health insurance system if the following conditions are met: (1) they have a valid marketing authorisation; (2) their price for Romania is approved by the Ministry of Health and (3) they are included in the national list of reimbursed medicines, approved by the Romanian Government based on the health technology assessment (HTA) performed by the National Agency of Medicines and Medical Devices. These rules are applicable also to orphan drugs.

The HTA legislation stipulates specific conditions for orphan drugs, which could improve their chances to have a favourable HTA decision. For example, the HTA norms provide for the prioritization of the evaluation of orphan drugs and for special evaluation criteria for them.

If the National Agency of Medicines and Medical Devices issues a favourable HTA decision, the medicines in question should be included in the reimbursement list.

8. How are the prices of Orphan Drugs regulated?

The competent authority which approves the prices of medicinal products in Romania is the Ministry of Health. The Ministry approves the prices of prescription-only (Rx) medicines, as well as of the prices of over-the-counter (OTC) medicines released based on medical prescription.

By law, the pricing rules applicable to innovative medicinal products are also applicable to orphan medicines. The norms issued by the Ministry of Health provide, amongst others, that: (i) the manufacturer price for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in 12 (twelve) comparison countries; (ii) the price should be approved by the Ministry of Health within 90 days as of receiving the price application dossier; and (iii) the price is valid for 1 (one) year.

Further to the approval of the manufacturer price, the maximum wholesale and retail prices are calculated by the Ministry of Health according to a special formula, by considering the maximum applicable wholesale and pharmacy margins set forth by the applicable regulations. The approved prices are published in the national price catalogues.

Every year, the marketing authorisation holders and/or their representatives should submit a price correction dossier with the Ministry of Health for updating the price of each medicine placed on the Romanian market. The updated price will be valid also for 1 (one) year.

9. In case of reference price based on a basket of countries, what countries are included?

As per the Romanian legislation, the 12 (twelve) reference countries taken into account when establishing the price for medicinal products are Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

There has been no significant legal or judicial development in relation to orphan medicinal products in Romania, during the last years.

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

The Ministry of Health organized a working group which should draft a new pricing methodology for medicinal products. It is expected for the new methodology to provide special exemptions and favourable rules for the pricing of certain categories of medicines. This reform might also impact the reimbursement of medicines in the Romanian health insurance system.

Therefore, it is advisable for the pharmaceutical companies acting in this field to closely monitor the legal developments in Romania.

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5. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Romania

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country.

By law, certain psychotropic substances extracted from cannabis, namely the substance having the international nonproprietary name Dronabinol (specifically, trans-delta-9-tetrahidrocanabinol) are considered “useful for medicine”, and can be used under a strict control.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The competent regulatory authorities dealing with psychotropic and narcotic medicinal products, including cannabinoid medicines, are the Ministry of Health and NAMMD. The authorization for growing cannabis plants for medical purposes is granted by the Ministry of Agriculture.

Thus, as a rule, it is permitted to cultivate plants containing substances under national control (such as tetrahydrocannabinol (THC) – which can be found not only in Cannabis indica, but also in Cannabis sativa), based on an authorization from the Ministry of Agriculture and/or the local departments in its subordination, on condition that (1) the crop is processed for technical purposes, to produce stalk, fiber, seed and oils, or for medical and scientific purposes; and (2) the THC level on the entire surface of the cultivated hemp shall not exceed 0.2%.

3. Is there a specific regulatory framework for the authorization, pricing and reimbursement of Cannabinoid Drugs?

In order to be authorized for marketing, a cannabinoid medicine should have an active substance relevant for medicinal purposes. The Romanian legislation provides for the list of cannabinoid substances which are relevant for such purposes, as well as for the list of prohibited substances.

There are no specific legal requirements for the pricing and reimbursement of such products, meaning that they should follow the normal procedures applicable for all medicinal products.

4. Which are the cannabinoid drugs that have received market approval to date?

Based on the publicly available information it appears that no cannabinoid medicine was authorized for marketing in Romania.

5. Who can prescribe Cannabinoid Drugs?

Currently, there are no special provisions for the prescription of cannabinoid medicines.

However, since the law provides that certain cannabinoid substances are qualified as psychotropic substances relevant for medical purposes, please note that the psychotropic substances should be prescribed by physicians using special, secured forms, within the medical units duly authorized by the Ministry of Health (hospitals, ambulatory care units or treatment centers).

In principle, cannabinoid medicines could be subject to additional prescription restrictions, in accordance with the terms of the marketing authorization and the therapeutic guidelines which shall be issued by the Ministry of Health. Since these products should be used under a strict control, we anticipate that the authorities will issue specific guidelines for ensuring such control.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No, there is no such list.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

The in force legislation does not provide special prescription procedures in respect of medicinal products with cannabinoid composition. Thus, they should observe the prescription rules applicable to psychotropic substances (as mentioned at Section 5 above), as well as any other rules which may be laid down in their marketing authorization.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

This is not expressly provided by the law.

However, please be advised that in order to distribute psychotropic substances it is required to have an authorization from NAMMD and the Ministry of Health. During the authorization process, the regulatory authorities shall verify, amongst others, the procedures implemented by the distributors for ensuring the safety and the security of the supply chain, and the storage and handling conditions.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

No, there is no such list.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

There is no ongoing procedure for reforming or changing the legal framework applicable to such products.

11. When are they likely to come into force?

While cannabinoid medicinal products are authorized for marketing in other EU member states, it is advisable for the companies acting in this field to closely monitor the legal developments in Romania.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal Cannabis is currently not authorized by the national legislation.

While the law on psychotropic and narcotic substances stipulates that, under certain conditions, cannabis can be grown for medical and scientific purposes based on the authorization of the Ministry of Agriculture, the terms and conditions for using medicinal cannabis in Romania have not been regulated to date. Unauthorized distribution and/or use of cannabis products can fall under the umbrella of the criminal legislation.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The competent regulatory authorities in the medicine field are the Ministry of Health and NAMMD.

Assuming that the medicinal cannabis will be authorized in Romania, it is likely that these authorities will be competent also for this type of products.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Not provided by the in force legislation.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Not provided by the in force legislation.

The competent authority authorizing the import and/or export of narcotic and/or psychotropic plants, substances and compounds, including but without limitation to plants, substances and/or compounds containing THC, is the Ministry of Health. However, even if medicinal cannabis could fall under these categories, currently the legislation does not regulate a procedure for authorizing the production, import or export of medicinal cannabis.

The Agricultural Payments and Interventions Agency (APIA) grants the import and/or export licenses for the following products:

a) seeds of varieties of hemp for sowing, falling within CN code 1207 99 20;

b) true hemp, raw or retted, falling within CN code 5302 10 00; and
c) hempseeds other than for sowing, falling within CN code 1207 99 91.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Not provided by the in force legislation.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Not provided by the in force legislation.

18. How can patients obtain Medicinal Cannabis?

Not provided by the in force legislation.

19. Who can prescribe Medicinal Cannabis?

Not provided by the in force legislation.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is no such list.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Not provided by the in force legislation.

22. Where is Medicinal Cannabis available?

Not provided by the in force legislation.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

There is no such list.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

In 2019, a group of 88 senators and deputies from the Romanian Parliament proposed a Draft Law on medicinal cannabis.

In 2021, the Romanian Government expressed a negative point of view regarding this Draft Law and the legislative procedure is currently pending at the Parliament’s level.

This legislative procedure is pending at the Parliament’s level, as the Draft Law needs to be assessed by the specialized commissions of the Parliament. It is difficult to anticipate if it will be adopted in the initial form proposed to the Parliament or when it will enter into force. It is advisable for the companies acting in this field to closely monitor the legal developments in Romania.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

By law, medicinal products having an opioid composition can be authorized for marketing in Romania. Opium and certain other active substances fall under the category of narcotic substances relevant for medical purposes, under a strict control.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The main regulatory authorities are the Ministry of Health, NAMMD and the National Health Insurance House.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

There are no specific legal requirements for the authorization, pricing and reimbursement of such products, meaning that they should follow the normal procedures applicable for all medicinal products.

Thus, these products should be authorized for marketing (by NAMMD or by the European Medicines Agency), should have the price approved by the Ministry of Health, and could be approved for reimbursement by the Romanian Government and the reimbursement authorities (i.e., the Ministry of Health and the National Health Insurance House).

28. Which are the Opioid drugs that have received market approval to date?

Numerous opioid medicinal products have been granted marketing authorization in Romania, including codeine, oxycodone, fentanyl, remifentanil, morphine, pethidine and methadone.

29. Who can prescribe Opioid Drugs?

As a response to rising rates of opioid misuse, the opioid-prescribing practice has been subject to certain national regulatory restrictions. Hence, opioid medicinal products can be prescribed by physicians only within authorized medical units (hospitals, ambulatory care units) or within drug addiction treatment centers, duly authorized by Ministry of Health.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is no such list.

31. What approvals or notifications are required to prescribe Opioid Drugs?

The medical units and the treatment center where opioid medicines are prescribed should be authorized to carry out such activities by the Ministry of Health.

The physicians who prescribe such medicines (e.g., in hospital or in ambulatory care) do not require a special license. However, the law provides for various obligations and rules which should be observed by the attending physicians, when prescribing narcotic substances.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

In order to distribute psychotropic or narcotic substances it is required to have an authorization from NAMMD and the Ministry of Health. During the authorization process, the regulatory authorities shall verify, amongst others, the procedures implemented by the distributor for ensuring the safety and the security of the supply chain, and the storage and handling conditions.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no such list.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There is no ongoing procedure for reforming or changing the legal framework applicable to such products.

35. When are they likely to come into force?

N/A.

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6. Patents and Trademarks: Romania

A brief overview of the situation regarding patents and trademarks in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What are the basic requirements to obtain patent and trademark protection?

As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on the specific provisions stipulated by the Romanian Trademark Law no. 84/1998, respectively by the Romanian Patent Law no 64/ 1991.

The invention must:

Show an element of novelty, meaning the new characteristic which is not known in the existing knowledge of its technical field. The existing knowledge is called “prior art”.
Involve an “inventive step” or “non-obvious”, which means that it could not be obviously deduced by a person having ordinary skill in the relevant technical field;
Have an industrial application, meaning that it must be capable of being used for an industrial or business purpose beyond a mere theoretical phenomenon, or be useful. Its subject matter must be accepted as “patentable” under law. In this respect, scientific theories, aesthetic creations, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods, methods for medical treatment (as opposed to medical products) or computer programs are generally not patentable;

Be disclosed in an application in a manner sufficiently clear and complete to enable it to be replicated by a person with an ordinary level of skill in the relevant technical field.

Trademarks:

The Romanian trademark system is based on the first-to-file principle and registration is possible without preliminary use.

Romania is a party to the following international trademark treaties:

the Paris Convention for the Protection of Industrial Property;
the World Intellectual Property Organisation Convention;
the Madrid Agreement on the International Registration of Marks;
the Madrid Protocol;
the Nice Agreement on the International Classification of Goods and Services;
the Vienna Agreement Establishing an International Classification of the Figurative Elements of Marks; and
the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).

The right to a national trademark shall be acquired and protected by registration with OSIM, a European trademark with the European Union, and an international trademark with WIPO, were Romania is a designated country.

The first step to registration is filing a trademark application, which will allow the TM Office to verify the basic requirements for granting the requested protection:

➢ If the requested trademark consist in a sign able to be represented in the Trademarks Registry, in such a way as to enable the authorities and the public to clearly and precisely determine the subject-matter of the protection conferred on their proprietor;

➢ if the sign is distinctive;

➢ if the sign is available and lawful;

➢ if the applicant provides with the proof of payment of the filing and examination fee, in the amount prescribed by the law.

Unregistered marks

There is no requirement to use a mark in order to acquire trademark rights. The Romanian trademark system is based on the first-to-file principle and registration is possible without preliminary use. If a trademark is refused registration for lack of distinctive character, this can be overcome by showing that the mark has acquired distinctive character through use prior to its application date.

The protection afforded to unregistered marks is limited to well-known trademarks. In order for a trademark to be considered well-known, it must be widely known in Romania among the relevant segment of consumers of the goods or services to which the trademark is applied.

Supplementary Protection Certificate

A particular type of protection, under specific conditions, is expressly stipulated in the field of medicines, in addition to the protection granted by a patent, so called supplementary protection.

A Supplementary Protection Certificate (“SPC”) is granted only for medicines and phytopharmaceutical products and is limited to the active ingredient or the combination of the active ingredients, for which the marketing authorization was granted. Therefore, the subject matter of the SPC is not the same with the subject matter of the patent covering the related medicines/ phytopharmaceutical products.

The SPC could be obtained if the holder/ the basic patent or his successor in title meets the following requirements stipulate by the law:

➢ the product is protected by a basic patent in force;

➢ a valid marketing authorisation (to place the product on the market as a medicinal product) has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

➢ the marketing authorisation referred to in the previous point is the first authorisation to place the product on the market as a medicinal product;

➢ the product has not already been the subject of a certificate;

➢ the application for the SPC is lodged within six months of the date on which the said marketing authorisation was granted/ on which the patent is granted (in hypothesis when the patent is granted after the marketing authorisation);

Once granted, the SPC extends the patent protection in respect of the active ingredient/ combination of active ingredients as to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the European Union. Taking into account that the pharmaceutical sector is a complex and sensitive one, the SPC shall not be granted for a period exceeding five years, except specific cases of medicinal products approved for a new, second use or for paediatric use, assuming that the legal requirements are fulfilled..

2. What agencies or bodies regulate patents and trademarks?

OSIM is the sole administrative authority in Romania entrusted with the protection of industrial property.

OSIM is a specialized body of the central public administration, subordinated to the Government, having, inter alia, the following main powers and duties:

to elaborate the strategy for developing the protection of industrial property in Romania and to apply the Governmental policy in the field;
to register and examine applications in the field of industrial property;
to issue protection titles granting exclusive rights on Romanian territory to their holders;
to administer the national registers related to industrial property rights.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Products, substances or processes can be protected by patents. None of these can enjoy protection also as trademarks. Protection conferred by a trademark can however be obtained for tri-dimensional forms (especially a product’s form or the form of its packaging), provided that such protection is not for the product/ packaging itself.

Patents can be granted in order to protect products, including substances, or processes which meet the conditions of novelty, inventive step and industrial applicability.

Specific provisions are stipulated in the field of biotechnology. Assuming that general said requests are met, patents in this field shall be granted if inventions relate to:

a biological material which is isolated from its natural environment or produced by any technical process;
plants or animals, if not limited to a specific plant variety or animal breed;
a microbiologic process or other technical process or product obtained by this process, other than a plant variety or an animal breed;
an isolated element of the human body or otherwise produced by a technical process, including a sequence or a partial sequence of a gene, even though the structure of that element is identical with the structure of a natural element.

In particular, being of major interest for the pharma sector, the products consisting in substances or compositions to be used in treatment and diagnosis methods are able to gain protection by patent. Also, any substance or composition which is already part of the state of the art is patentable for use in relation to a treatment or diagnosis method for humans or animals if such use is not in the state of the art (patents for second medical use).

Products and processes excepted from patentability are expressly provided by the law:

Discoveries, scientific theories and mathematical methods;
Aesthetic creations;
Schemes, rules, methods for performing mental activities, in relation to games or economic activities, as well as computer programs;
Mere presentations of information;
Inventions the commercial exploitation of which would be contrary to the public order or morality, including those harmful to the health and life of humans, animals or plants and able to seriously affect the environment;
Plant varieties, animal breeds and essentially biological processes for the production of plants or animals, except for microbiological processes and products of them;
Inventions having as object the human body in its various formation and development stages and the mere discovery of one of its elements, including the sequence or partial sequence of a gene;
Treatment methods of the human or animal body, by surgery or therapy, and diagnosis methods performed on the human or animal body, except for products, in particular substances or compositions for use in any of these methods.

4. How can patents and trademarks be revoked?

TRADEMARKS

The registration of a trademark can be invalidated or revoked by filing an application with the competent court – the BucharestTribunal. As of 14 January 2023, the TM Office will also have the jurisdiction to settle the invalidation and or revocation requests..

Invalidity

The trademark invalidity application can be filed at any time during the protection period, based on any of the following grounds:

Breaching the legal provisions regarding the registration requirements;
The trademark application was filed in bad faith;

Invalidity has retroactive effects and can be requested to the Bucharest Tribunal. As of 14 January 2023, cancellation claims can also be filed with OSIM, in administrative procedures.

Revocation

A revocation action of a trademark can be filed at any time during the protection period, based on the following grounds:

Non-use for an interrupted period of 5 years, without justification;
The trademark has become either generic or deceptive;
The trade mark has been registered by a person who is not the applicant or holder.

PATENTS

After the registration of a patent, an interested party has an administrative remedy, by filing a revocation request with the OSIM (A) and a judiciary remedy, by requesting the annulation before the competent court, namely the Bucharest Tribunal (B).

A. The revocation of a patent can be sought within six months from publication of patent grant, if:

a. the subject-matter of the invention is not patentable;

b. it does not disclose the invention clearly enough so that a person skilled in the art can carry it out;

c. it extends protection beyond the contents of the filed application;

B. A patent can be annulled in the three above situations and also if:

d. the patent protection has been extended;

e. the patent holder is not entitled to the patent.

The patent annulment application can be filed at any time during the validity of the patent, except when it is based on the reasons mentioned at points a-c, where it can be filed at any time during the validity of the patent, but only after the expiry of the deadline for revocation.

The revocation or the annulment can be granted only partially where the grounds for revocation or annulment are valid only with regard to part of the patent.

5. Are foreign patents and trademarks recognized and under what circumstances?

TRADEMARKS

European Union trademarks are fully protected in Romania, in the same way as national trademarks.
International trademarks are also protected in Romania to the same effect as national trademarks, provided that Romania or the European Union are designated territories and that an application of extending the trademark protection is filed, according to the Madrid Agreement concerning the international registration of marks (the “Madrid Agreement”) and to the Protocol adopted at Madrid relating to the Madrid Agreement (the “Madrid Protocol”).

Generally, OSIM will proceed to examine such application, according to the national legislation, as in the case of a national application. Exception to this rule is provided for in article 6 quinquies of the Paris Convention, where a trademark registered in a member state of the Paris Convention shall be admitted tale quale, provided that it does not affect prior acquired rights, is distinctive, not contrary to the public moral or order and it is not capable of deceiving the public.

Another form of recognition of foreign rights is the possibility of claiming priority.

A trademark application filed in a foreign country which is member state of the Paris Convention or of the World Trade Organization may be invoked within 6 months from its deposit date in order to claim priority in Romania.

A priority claim can be translated as a request to receive for the Romanian application the deposit date of a foreign application.

PATENTS

Patents registered under the Patent Cooperation Treaty (“PCT”) and European patents validated in Romania are protected in Romania in the same way as national patents.

Also, OSIM is the receiving office for international applications, responsible with the verification and transmission of the application to the International Office according to the PCT.

For the purposes of the validation, the applicant has to file a form for opening the national phase – in case of international applications – and/or an application for extending the protection in the territory – in case of European applications – following to which the application shall be subject to the procedures provided by the national laws, exactly as a regular national application. The submission of the translation of the relevant documents with the OSIM is mandatory in order to be published in the Industrial Property Official Bulletin so as the patent could have full effects in Romania.

An international or a European application designating Romania will have the same deposit date in Romania as the deposit date of the prior application. Accordingly, the national application will take into consideration the priority claims invoked by way of international or European procedure.

The applicant has the possibility to limit its international or European application and continue the national phase only for a part of it.

An international application shall not have effects in Romania if the applicant has withdrawn the application or the application is deemed to be withdrawn according to the PCT, if a national phase or a regional phase before EPO has not been opened or in the regional phase opened before EPO does not designate Romania.

Other forms of recognition of foreign patents and applications are the state of art and the priority claim.
The state of art also includes the international applications for which the national phase has opened and the European applications designating Romania.

A proprietor can also enjoy the priority claim. A patent application filed in a foreign country which is member state of the Paris Convention or of the World Trade Organization may be invoked within 12 months from its deposit date in order to claim priority in Romania.

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

With regard to patents, the law adds a protection based on data and marketing exclusivity (A).

A. Without contradicting the applicable laws on patents and trademarks, the Health Law grants a marketing exclusivity period for the innovative medicines, equal to 10 years from the first authorization, during which the commercialization of the related generic medicines is prohibited. This period can be prolonged by maximum 1 year if new therapeutic indications for the medicines are discovered and authorized in the first 8 years from the first authorization.

Furthermore, the Health Law grants an 8 years period of protection for data exclusivity in connection with innovative medicines, during which the data resulted from the pre-clinical and clinical trials conducted in relation to the innovative medicines cannot be referenced in the filings for the related generic medicine, for the same substance.

Additionally to these 8 and 10 years of data and marketing exclusivity, a period of 1 year of exclusivity is granted for applying for a new indication of a substance with pre-established use, if significant clinical and preclinical trials have been conducted for the new indication.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Apart from the restrictions described at point 3., no other limitations regarding types of medicines or devices are provided by the Romanian laws.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Any license concerning a Romanian patent or trademark, regardless of the nationality of the licensor or of the licensee, must be registered with the OSIM in order to be ostensible towards third parties. Note should be made that the validity of the license is not conditioned by such registration.

The license must be registered in the Register administered by OSIM, with payment of an administrative fee, following to which the grant shall be published in the Official Bulletin of Industrial Property. As of the date of this publication, the license shall be enforceable against third parties.

However, enforceability against third parties can also be proven by a direct notice to the third parties conveyed by the licensor or licensee.

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7. Regulatory Reforms: Romania

The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. Are there proposals for reform or significant change to the healthcare system?

The Romanian authorities announced their intention to implement certain

reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system?

the new advertising norms for medical devices will bring significant changes in connection with the marketing and advertising activities which can be performed in Romania for such products;
the Ministry of Health set up a special working group in charge with the assessment of the current pricing methodology for medicinal products, aiming to improve the pricing methodology for the benefit of both the marketing authorisation holders and the patients;
the Romanian authorities contemplate the amendment of the legislation on the health technology assessment for medicinal products, based on in depth studies prepared by international financial institutions;
the improvement of the healthcare infrastructure, including by financing and building new hospitals and sanitary units;
the expansion of telemedicine and of the various types of medical services which can be provided at a distance;
new pilot projects in certain therapeutic areas;
the catalogue of medical devices reimbursed in Romania;
the reorganization of NAMMD.

2. When are they likely to come into force?

The legislative changes mentioned above could enter into force and be further developed in the upcoming period.

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8. Product Liability: Romania

Product liability in Romanian Pharma – a legal guide. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What types of liability are recognized in your jurisdiction?

The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case.

Additionally, the competent authorities in various fields can apply fines and other sanctions when the breach is related to competition law, consumer protection, misleading and comparative advertising, IP law.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The Health Law provides a general reference to the legislation applicable for each type of liability. Also, in several cases, the Health Law specifically stipulates the type of liability and sanction applicable to a particular breach or to blocks of breaches.

The civil liability refers to the civil obligation to cover any damage caused either by breach of contract (contractual liability) or by the committing of an illicit action (tort liability).

As a general rule, manufacturers are liable according to Law no. 240/2004 on the liability of manufacturers for damages caused by defective products. Manufacturers have to ensure the security of the manufactured product at a level of consumers’ expectancy considering the presentation of the product, its predictable uses and the date of releasing it on the market. Otherwise, they are liable for the current and future damage caused by the defects of their product. In order to trigger the civil liability of the manufacturer, the injured person must prove the damage, defect and causation between the defect and the damage.

Additionally, the Health Law specifically provides that the manufacturers of medical equipment and medical devices, medicinal substances and sanitary materials are liable according to civil law for the damage caused to patients during prevention, diagnosis and treatment activities, generated directly or indirectly by hidden defects of the products, during the warranty/validity period, in accordance with the legislation in force.

Criminal liability may be applied in several cases to manufacturers of medicines and devices for breaching the Criminal Code or other criminal law related provisions included within other laws. According to the Health Law, the breach of the regulations on medicines’ good clinical practice and the conduct of clinical studies by unqualified employees are considered criminal offences.

Administrative liability arises from administrative offences, sanctioned by the public authorities. Administrative offences may include: breach of the legislation related to competition or consumer protection, non-compliance with licensing, advertising, manufacturing and distribution requirements, etc.

Disciplinary liability is usually applicable in connection with (i) the disrespect of mandatory provisions on the profession or deontology and of good professional practices and (ii) labour obligations, by the employer to the employee, where a labour or collaboration agreement exists. The Health Law does not specifically detail the applicability of this type of liability in the case of manufacturers of medicines and medical devices.

Material liability is usually connected to labour relationships and it is triggered where a material damage is caused by one of the involved parties.

There is a thin line between the above-mentioned types of liabilities, which can be cumulated depending on the illicit deed causing the prejudice.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

According to the Romanian Civil Code, a legal person is liable for the deeds of its organs if committed in connection with the attributions or with the purpose of the occupied position at the respective company. The liability of the legal person does not exclude the liability of the natural person, regardless of its position in the company. The company is entitled to sue for compensation the natural person responsible for the illicit deed.

Similarly, from a criminal law perspective, the legal person, with the exception of the state and the public authorities, is liable for criminal offenses committed in pursuit of the object of activity or in the interest or on behalf of the legal person. The criminal liability of the legal person does not exclude the criminal liability of the natural person who contributed to the same deed.

4. How can a liability claim be brought?

Claimants can file civil and criminal challenges with the competent courts against a manufacturer, to claim for damage caused by the defect(s) of the product. As a rule, a product liability claim can be brought within three years as of the date the claimant was aware or should have been aware of the damage, the product’s defect and the identity of the manufacturer, but no later than ten years as of the date when the product in question was first placed on the market by the manufacturer.

NAMMD inspectors could apply sanctions (following inspections or complaints) in case of offences in connection with the breach of obligations incumbent to manufacturers.

Additionally, the Romanian legislation provides for different procedures to be carried out by the competent authorities in different fields.

Thus, as a rule, the competent authorities could apply sanctions when finding the applicable legislation is breached, following complaints (e.g., filed by consumers or competitors) following ex officio inspections or other specific procedures. This is the case of the sanctions applied, inter alia, by the Competition Council, National Authority for Consumer Protection, Ministry of Health, Ministry of Finance, National Audiovisual Council.

5. What defenses are available?

According to the Health Law, civil and administrative liability of marketing authorization holders, manufacturers and qualified healthcare professionals is not engaged for the consequences resulting from:

the use of a medicinal product other than for authorized indications;
use of an unauthorized medicinal product where such use is recommended or required by a competent national authority in response to a suspicion of spread or confirmed spread of pathogens, toxins, chemical agents or nuclear radiation, liable to produce damage.

Also, the legislation on liability of manufacturers for damages caused by defective products provides that manufacturers of various products are not liable in the following cases:

the product was not placed on the market by the manufacturer;
depending on the circumstances, the defect that caused the damage did not exist at the time the product was placed on the market or appeared after the product was placed on the market, due to causes independent of the manufacturer;
the product was not manufactured for trading or other form of distribution for the manufacturer’s economic purposes, and was not manufactured or distributed during its business activity;
the defect is due to compliance with mandatory requirements imposed by regulations issued by the competent authorities;
the state of scientific and technical knowledge at the moment the product was placed on the market did not allow the discovery of the defect;
the defect is caused by the consumer, due to non-observance of the instructions for use.

Note should be made that, by law, any contractual limitation or exemption from liability of the manufacturer is null and void.

Additionally, in terms of civil law, one common defense is the lack of causation between the illicit deed and the damage. Also, the rules on force majeure or fortuitous case could be applicable.

From a criminal law perspective, the offense is the sole ground of criminal liability. Therefore, no sanction can be applied if the concerned deed does not meet the conditions of an offense.

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9. Traditional Medicines and OTC Products: Romania

The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and for the homeopathic medicinal products.

Traditional herbal medicinal products can be authorized by NAMMD for marketing in Romania under a simplified 120 days authorization procedure, if they meet certain conditions, such as:

they should have adequate indications for this category of products which, due to their composition and purpose, are intended and designed for use without the supervision of a physician as to establishing a diagnosis, prescription and monitoring the treatment;
the means of administration must be oral, external and/ or by inhalation;
the information regarding the traditional use of the product should be sufficient, meaning that they prove that the product is not harmful under the prescribed conditions of use or that the pharmacological effects or the efficacy of the product are plausible based on its extended use and experience.

The marketing authorization for homeopathic medicinal products can also be granted by NAMMD under a simplified 120 days authorization procedure, if they meet all of the following conditions:

the means of administration is either oral or external;
there aren’t any specific therapeutic indications on the product’s labelling or in any information related to the respective product;
there is a high degree of dilution to guarantee a safe use; in particular, the homeopathic medicinal product may not contain either more than one part per 10,000 of the mother tincture or more than 1% of the smallest dose used in allopathy for the active substances whose presence in an allopathic medicinal product requires a physician’s prescription.

In certain cases, the 120 days period necessary for the issuance of the marketing authorization for traditional herbal medicinal products and for the homeopathic medicinal products may be extended by NAMMD, up to 210 days.

If these type of products do not meet the legal requirement for the simplified authorization procedures, they can be authorized by NAMMD under the general authorization procedure for medicinal products.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

In principle, homeopathic and traditional herbal medicinal products can be advertised directly to the public, provided that they have a valid marketing authorization, they are not released based on medical prescription and they are not reimbursed in the social health insurance system. For certain advertisements and promotional projects, it is required to obtain the prior approval of NAMMD.

It is noteworthy that the Romanian legislation provides for various restrictions and limitations in relation to the advertising and promotion of medicinal products to the general public, which should be assessed on a case by case basis.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

In the case of traditional herbal medicinal products:

the labelling and package leaflet should mention the product’s qualification as “traditional herbal medicine” and that: (a) the product is intended for use under the specified indications, exclusively based on its long-standing use; (b) the user should request an opinion from a physician or another healthcare professional if the symptoms persist or if any adverse reactions occur while using the product, other than the ones in the leaflet;
all advertising materials should include the following warning: “This traditional herbal medicinal product shall be used for the specified indications, exclusively based on long-standing use.”

The labelling and package of homeopathic medicinal products leaflet should mention the product’s qualification as “homeopathic medicine” and other details, such as:

the degree of dilution and the related symbols from the European Pharmacopoeia;
the name and address of the marketing authorization holder and manufacturer;
the expiry date and the pharmaceutical form;
safety precautions and warnings, as the case may be;
the indication “homeopathic medicinal product without any prior approved therapeutic indications”;
number of the manufacturing series; and
a special recommendation that the user should request an opinion from a physician if the symptoms persist.

In accordance with the Health Law, advertising materials designed for the general public, including the ones concerning homeopathic and traditional herbal medicines should not suggest, amongst others, that:

proper medical consultation or surgical intervention is not necessary, especially by offering diagnosis or long distance treatment suggestions;
the respective medicine has a guaranteed effect and is not likely to cause adverse reactions;
the effects are better than or equivalent to the ones of a different treatment or of another active substance, unless there is scientific evidence to support such claim;
the patient’s overall health can only be improved by using the advertised homeopathic or herbal medicine;
the patient’s overall health shall be affected if the product is not used.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Marketing Authorization

According to the Health Law, medicinal products can be authorized for marketing as over-the-counter (OTC) products if they do not fulfill the criteria for being qualified as products released based on medical prescription (Rx), by taking into consideration, amongst others, the following:

the direct or indirect risks that can occur if the product is used without a physician’s supervision, even if it would be correctly administrated;
the product’s composition, and specifically its substances or preparations thereof;
if the product is frequently used, and if the consumers use it incorrectly, to assess if there is any direct or indirect danger for human health;
if the product is normally prescribed by a doctor to be administered parenterally.

Price

As opposed to the price of Rx medicinal products which is approved by the Ministry of Health, marketing authorization holders are entitled to independently set the prices of their OTC medicinal products.

However, according to the Ministry of Health’s Order no. 368/2017, the prices of OTCs prescribed and dispensed in the national health insurance system should be approved by the Ministry of Health.

Trade

Pursuant to the Pharmacy Law, pharmacies can sell OTC medicinal products online, but they are not allowed to sell prescription – only medicines online.

5. Are there any limitations on locations or channels through which OTC products may be sold?

The distribution channels are similar for Rx and OTC medicinal products, since both types of products can be sold by the manufacturers and/or the wholesale distributors to the open circuit (community) pharmacies and to the closed circuit (hospital) pharmacies, which will dispense them to the patients.

Additionally, the Pharmacy Law was amended in 2018 to provide for the possibility of authorized community pharmacies to sell OTC medicines to the patients online. In order to perform online sales of medicines, the community pharmacies should submit a special notification to the Ministry of Health and create a website which should fulfill certain requirements, which should be further detailed in the near future by secondary legislation.

6. What health, advertising, and marketing claims may be made for OTC products?

According to the Health Law, the advertisements for OTC medicines should include a recommendation to carefully assess the information provided on the package or in the package leaflet, as follows: “This medicine can be released without medical prescription. Please read carefully the leaflet or the packaging information. In case of any adverse reaction, please seek the assistance of a physician or pharmacist.”

The claims used for OTC products should also comply with the general legal requirements applicable to medicinal products. If the advertising and/or promotional activities are designed for the general public, they should observe the requirements mentioned at Chapter 3 Questions 15 – 20.

7. Can OTC products be marketed or advertised directly to the public?

OTC medicinal products can be advertised directly to the general public, provided that general requirements on advertising medicinal products are met and the advertisement material mentions the warning formula specified in Chapter 4, Question 6, above. For certain promotional and educational materials addressed to the public, including for the information posted on internet websites, it is required to obtain the prior approval of NAMMD.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

According to the Health Law, NAMMD can approve the re-classification of a medicinal product from “subject to medical prescription” to “over-the-counter”, based on a prior assessment of any new information brought to its attention by the applicant, which would prove that the product in question does not longer meet the criteria for being qualified as Rx.

In this respect, NAMMD shall assess the criteria mentioned at Chapter 4, Question 6, above in relation to the updated situation of the concerned medicine.

Additionally, the Health Law provides that if the classification is changed based on certain significant pre-clinical tests or clinical trials, NAMMD shall not refer to the results of such tests or trials when examining a request by another applicant or marketing authorization holder for a change of classification of the same substance, for a period of 1 (one) year after the authorization of the initial change.

9. What are the requirements for the importation of either traditional medicines or OTC products?

In order to import OTC and/or other medicinal products in Romania, it is necessary to obtain an import authorization from NAMMD. To this end, the applicant should submit an application dossier with NAMMD, containing various information on the imported medicines, the import facilities and the relevant personnel, which will be verified by NAMMD during an inspection.

If the importer does not own their own warehouse, it could conclude a services agreement with a wholesale distributor which shall act as a logistic services provider.

The procedure for the issuance of the import authorization should be completed within 90 days from the filing of the complete dossier. The authorization shall specify the medicines which are imported and their manufacturers.

According to the Health Law, NAMMD should take adequate measures to ensure that the imported medicines were subject to relevant quality controls, and specifically that the batch release was performed in accordance with the requirements resulting from the marketing authorization.

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10. Marketing, Manufacturing, Packaging & Labeling, Advertising: Romania

Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?

In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national evaluation procedure or under the mutual recognition or decentralized procedures) or by the European Medicines Agency (EMA) at the centralized EU level.

For the new, innovative medicines, the marketing authorization application dossier contains various information regarding the product in question, its manufacturer, the characteristics of the active substance, the therapeutic indications and adverse reactions, including the results of the pharmaceutical tests, the pre-clinical tests and of the clinical trials, the risk management plan and the pharmacovigilance system to be implemented by the marketing authorization holder.

The marketing authorization is issued by NAMMD, under the national procedure, within a maximum of 210 days of submitting the complete application dossier. In case of the mutual recognition or decentralized procedures, where Romanian acts as interested member state, NAMMD should issue the marketing authorization within maximum 120 days from receiving the evaluation report from the reference member state.

In the case of medical devices, it is required: (a) at EU level, to obtain the CE trade mark and (b) at local level, to register certain medical devices in the National Medical Devices Database, by submitting an application dossier with NAMMD. The registration certificate for the National Medical Devices Database shall be issued within 60 days from the filing of the notification form and of the related documents with NAMMD.

2. What is the authorization process for the marketing of generic versions of these products?

The authorization process for generics is similar. The main difference is that if the applicant proves that the product is a generic version of a reference (innovative) medicinal product which has been authorized either in Romania, in another EU Member state or in the EU at centralized level for at least 8 (eight) years, it is not necessary to submit the results of the preclinical tests and of the clinical trials. Another difference is that, in practice, the marketing authorization for generic products may be issued faster than 210 days.

By law, the generic medicine authorized based on the results of pre-clinical tests and clinical trials of an innovative product cannot be placed on the market until 10 years have elapsed from the initial authorization of the latter (the “data exclusivity period”).

3. What are the typical fees for marketing approval?

When submitting the marketing authorization dossier for a medicinal product, the applicant should pay an administrative fee of EUR 5,000.

The administrative fee for the evaluation of the marketing authorization dossier ranges between EUR 900 and EUR 9,500 depending on the type of product, the relevant procedure and the applicable circumstances.

The fees are expressly provided by an order issued by the Ministry of Health. For example, the law provides for a fee of EUR 9,500 for the authorization of an innovative product under the national procedure, EUR 5,700 for the authorization of a generic product under the national procedure and EUR 6,650 for the authorization of a biosimilar under the national procedure.

4. What is the period of authorization and the renewal process?

The marketing authorization granted by NAMMD is valid for an initial period of 5 (five) years, at the end of which it can be renewed for an unlimited period. In justified cases, NAMMD can approve the renewal of the marketing authorization for a limited period of 5 (five) years.

The renewal procedure requires the marketing authorization holder to file, not later than 9 (nine) months before the expiry date, an application together with certain relevant information regarding the product, including a consolidated version of the marketing authorization dossier on the quality, safety and efficacy of the medicinal product, the evaluation of the data in the reports on suspected adverse reactions and the periodic updated safety reports and relevant data regarding the variations occurred after the marketing authorization.

5. What are the requirements, if any, for post-approval pharmacovigilance?

As a rule, marketing authorization holders should submit to the European Medicines Agency periodic updated safety reports containing (a) summaries of the relevant data on the benefits and risks of the medicine, including the results of the related studies, (b) a scientific assessment of the risk-benefit report and (c) relevant data on the sales and the prescription of the respective medicine. Such reports have to be provided in electronic format, in accordance with the timeframe set by the marketing authorization.

The periodic updated safety reports should be submitted with NAMMD:

before placing the product on the market, every 6 (six) months as of the marketing authorization date;
after placing the product on the market, (a) every 6 (six) months during the first 2 (two) years; (b) once a year, for the 3rd and 4th year after its placing on the market; and afterwards, (c) every 3 (three) years.

NAMMD assesses the periodic updated safety reports to determine potential new risks, changes in the risks already known or changes in the risk-benefit balance and, as the case may be, adequate measures concerning the terms of the marketing authorization. Based on such assessment, NAMMD could maintain, modify, suspend or withdraw the marketing authorization.

6. Are foreign marketing authorizations recognized?

The marketing authorization issued at centralized level by the European Medicines Agency (EMA) is valid in Romania. Before placing on the Romanian market a product authorized under the centralized procedure, the marketing authorization holder should submit certain information with NAMMD concerning the product’s classification.

The marketing authorization issued for a medicinal product in another EU member state can be used for obtaining the marketing authorization in Romania from NAMMD, pursuant to the mutual recognition procedure.

By way of exception, the medicines which are donated to Romanian healthcare units can be authorized for marketing in the European Economic Area or in the United States of America. All medicines donations need to be approved by NAMMD.

7. Are parallel imports of medicines or devices allowed?

Parallel imports of products from EU member States are allowed and supported by EU and Romanian legislation, as a tool for achieving and maintaining a Single Internal Market, based on the principle of free movement of goods. Parallel imports from non-EU Member States are not covered by this legal regime and hence they are subject to general import rules.

As a general principle, the hindering of parallel imports from EU Member States is subject to sanctions based on competition legislation and EU single market rules.

Pharma Regulatory perspective

The parallel imports of medicines, intended as cross-border sales of goods by independent distributors outside the manufacturer’s or its licensed distributors’ formal channels, must be carried out with the observance of specific regulatory conditions, particularly:

the product concerned by the import to be identical or very similar to a product already authorized for sale in Romania and
the distributor to hold a parallel import license from NAMMD (except for medicines authorized through a centralized procedure).

NAMMD issues parallel import authorizations when the following conditions are met:

the existence of a market authorization issued by the NAMMD for the primary directly distributed medicinal product;
the parallel imported medicine should be (a) imported from an EU member State or from the EEA; (b) subject to a market authorization in force in the country of export; (c) sufficiently similar to the primary distributed medicinal product, even though some differences regarding the excipients may exist; and
the applicant should provide data or arguments that make it at least plausible that the efficacy and safety of the primary directly distributed medicinal product apply also to the parallel imported medicine.

The parallel import authorization is issued by NAMMD within 45 days from the submission of the relevant complete file. The authorization is issued for each medicinal product and is valid for five years, with the possibility of renewal.

The parallel importer must:

hold a wholesale distribution authorization;
hold a manufacturing authorization, if the importer intends to amend the labelling or outer packaging;
comply with the rules on good distribution practice and, where applicable, the rules on good manufacturing practice.

The price of the parallel imported medicines should be approved by the Ministry of Health within 60 days from the receipt of the pricing application from the parallel import authorization holder.

Competition rules

The restriction of parallel trade of products, including medicines, qualifies as hardcore restriction of competition, which infringes both Article 5 of the Romanian competition law no. 21/1996 (the “Competition Law”) and Article 101 of the Treaty on the Functioning of the European Union (“TFEU”). Parallel trade restrictions cannot benefit of category exemption under European Commission Regulation 330/2010 and are very unlikely to benefit of individual exemption under Article 101 (3) TFEU or Article 5 (2) of the Competition Law. Such restrictions may be sanctioned by the Romanian Competition Council with fines ranging between 0.5% of the total revenues obtained by the relevant company on the Romanian territory and 10% of the worldwide turnover of the relevant company, where both the revenues and the turnover considered are achieved in the year prior to the issuance of the sanctioning decision.

Parallel trade restriction carried out through unilateral conduct of a company in a dominant position on the market, may raise competition risks as well, especially in cases of refusal to supply. Under relevant case law, although it is accepted that manufacturers should have the option of taking reasonable measures to protect their commercial interests, they may not refuse orders of a customary nature in an attempt to prevent parallel exports, as this may amount to an abuse of the dominant position in violation of article 6 of the Competition Law and Article 102 of the TFEU. These restrictions may also be sanctioned by the Romanian Competition Council with fines ranging between 0.5% of the total revenues obtained by the relevant company on the Romanian territory and 10% of the worldwide turnover of the relevant company. The revenues and the turnover considered are those achieved in the year prior to the issuance of the sanctioning decision. However, a Member State of destination of the import can legally stop or restrict parallel imports of certain products, if the restrictive measure aims at the protection of human health and life or the protection of industrial and commercial property (e.g. trademarks, patents).

IP law

The parallel importer is personally liable for legal issues resulting from the infringements of the brand or industrial property rights related to the imported product. Therefore, if a parallel importer breaches certain IP rights (e.g. in relation to registered trademarks), the holder of the relevant IP rights can request the parallel importer to solve the issues and/or pay damages.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

The Health Law, the Advertising Guidelines approved by the Ministry of Health’s Order no. 194/2015 and the industry codes provide for various limitations concerning gifts and sponsorships which can be granted to healthcare professionals and healthcare organization, as well as rules on the services and consultancy agreements that may be concluded with them.

According to the Health Law, healthcare professionals are prohibited to be supplied with, offered or promised any gifts, pecuniary advantages or benefits in order to prescribe, purchase, supply, trade or administer medicines. The breach of these provisions can also fall under the umbrella of the anti – bribery legislation.

Promotional materials may be granted to healthcare professionals only if their value is not higher than RON 150 (roughly EUR 30), including VAT, and if they are relevant to the medicinal or pharmaceutical practice.

Physicians can receive sponsorships for certain medical, educational and/or scientific activities, including but without limitation for the participation to promotional and scientific events. Pursuant to the Health Law, the sponsorship can cover relevant expenses such as travel and accommodation costs, while the payment for entertainment is forbidden.

Non-profit organizations (NGOs) acting in the healthcare field can receive sponsorships for their activities in the medical, educational, scientific and humanitarian field, and in certain other fields provided for by the Sponsorship Law.

Similar to the Sunshine Act from the USA, the Romanian legislation expressly requires pharmaceutical and medical devices companies, and the wholesale and retail distributors, to declare to NAMMD and the Ministry of Health all sponsorships granted to healthcare professionals and to healthcare organizations, as well as the agreements concluded with such persons and entities. This information is published on the authorities’ website.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturing of medicinal products in Romania, including the partial manufacturing activities such as re-packaging and re-labelling, can only be performed by the entities holding a manufacturing authorization issued by NAMMD.

In order to obtain the manufacturing authorization, one should submit with NAMMD an application dossier containing various information regarding:

the personnel involved in the manufacturing activities, including the qualified person which should be specialized in one of the following fields: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical technology and biology;
the manufacturing premises and the technical equipment;
the system implemented for supervising the manufacturing process; and
the medicines and pharmaceutical forms which are produced or imported.

According to the Health Law, NAMMD should inspect the premises, to verify the accuracy of the information provided by the applicant, and should issue the authorization within 90 days of submitting the necessary documentation.

NAMMD is the competent authority also in the medical devices field, and in this capacity it issues the authorizations for the trade, repair, maintenance and installation of medical devices. The law does not expressly regulate the procedure for obtaining an authorization for the manufacturing of medical devices in Romania.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

The Romanian legislation on medicines manufacturing is compatible with the Good Manufacturing Practices approved by the European Medicines Agency, since Directive no. 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use was transposed into the Romanian legislation.

According to the local legislation, the issuance of the manufacturing authorization and of the good manufacturing practices certificate by NAMMD is carried out in accordance with the principles and rules set forth by the European Guidelines on Good Manufacturing Practices. In this respect, NAMMD should:

verify the observance of the principles and guidelines on Good Manufacturing Practices for medicinal products issued by the European Commission; and
comply with the procedures approved at the level of the European Union regarding the manufacturing inspections and the information exchange;
register the certificates on good manufacturing practices in the European Union database, which is managed by the European Medicines Agency.

In 2017, the Scientific Council of NAMMD issued the updated guidelines on good manufacturing practices, in accordance with the latest updates in the European legislation on medicines manufacturing.

11. What is the inspection regime for manufacturing facilities?

NAMMD carries out periodic and sometimes unannounced inspections at the premises of manufacturing entities to determine if the latter comply with the guidelines on good manufacturing practices and the other applicable requirements, aiming to ensure the protection of the public health at a level at least equivalent to that of the European Union.

NAMMD’s inspectors are empowered to control the activities performed by the manufacturing units, including to take samples of medicinal products for independent laboratory tests, as the case may be. The findings from the inspection and the required measures shall be comprised in the inspection report, which shall be communicated by NAMMD to the holder of the manufacturing authorization.

By law, the inspections carried out by NAMMD should comply with the inspection procedures issued by the European Commission and with the local guidelines transposing into the local legislation the EU enactments on inspection procedures.

In addition to inspections carried out by NAMMD, the manufacturers should ensure compliance with the requirements set forth in the GMPs guidelines by implementing a self-inspection system for the manufacturing facilities. The conclusions of any such inspection should be included in a report, along with the relevant proposals on corrective measures, as the case may be.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

According to the Health Law, the inspections concerning the manufacturing facilities are carried out by NAMMD’s inspectors. The law provides for various rules on the collaboration with the European Medicines Agency and other competent authorities, amongst which:

NAMMD cooperates with the European Medicines Agency and exchanges information with the latter concerning the inspections, to ensure that legal requirements on medicinal products are observed;
the inspections can be carried out either in Romania or in a third country, or in another EU Member State, based on the request of NAMMD, of another Member State, of the European Commission or of the European Medicines Agency;
NAMMD should communicate to the European Commission and the European Medicines Agency the relevant conclusions of the inspection.

Consequently, the European Medicines Agency is entitled to request the performance of the inspection and to cooperate with NAMMD during the inspection, however the inspection activities shall be carried out by NAMMD. The law does not expressly provide for the possibility of foreign inspectors to carry out the inspection.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Medicinal products:

According to the applicable legislation and guidelines, medicinal products must be stored separately from other products, with the purpose of avoiding alteration and protecting them from the harmful effects of light, humidity, temperature, as well as other external factors. In addition, storage facilities must be adequately illuminated and have a solid structure and sufficient capacity as to ensure a safe storage and handling.

The access to medicinal products must be limited to authorized personnel. Inside the storage areas, the presence of food supply, beverages, and articles for smokers and medicinal products for personal use is strictly forbidden.

The handling and/or transportation activities should be performed using special vehicles and equipment, in a manner that prevents any leakage, rupture, contamination and mixing of substances. Moreover, it is mandatory to plan the transport based on a risk assessment approach. Regardless of the means of transportation, the distributor should be able to prove that the products have not been exposed to conditions that might compromise their quality and integrity.

In respect of the packaging requirements envisaged by the law, the mandatory information should be mentioned on the label in Romanian language (solely or with other language). The law provides for certain exceptions to this rule (i.e., for certain orphan medicines). Also, the inclusion of a package leaflet in the package of all medicinal products is mandatory, unless all the information to be mentioned thereto is written on the secondary or primary packaging.

Medical devices:

By law, in order to be traded in Romania, the medical devices must be designed, manufactured and packaged in such a way that their characteristics and performance during use are not affected by transport and storage, in accordance with the instructions and information provided by the manufacturer. Also, it is necessary to minimize the risk of contaminants and residues to persons involved in their transport and storage as well as to users of the devices, taking into account the intended purpose of the product. Special attention should be paid to exposed tissues, duration and frequency of exposure.

The devices delivered in a sterile condition must be designed, manufactured and packaged in disposable packages and/or in a way that ensures that they are sterile when placed on the market, during storage and transport under conditions specified by the manufacturer, and that they remain sterile until damage or opening of the protective packaging.

In respect of packaging medicinal products, the CE marking is mandatory, provided in a conspicuous, clearly legible and indelible manner, either on the device or on its sterile package, as well as included in the instructions for use. Custom-made medical devices and medical devices intended for clinical investigation are exempt from compliance with this condition.

The package and/or the label of the medical device must allow the differentiation between identical or similar traded products, in both sterile and non-sterile form. As well as in the case of medicines, the label should be in Romanian language (solely or with other language).

14. What information must be included in medicine and device labeling?

The information on the label of medicinal products, provided on the primary and on the secondary packaging, includes:

the name of the medicinal product followed by its strength and pharmaceutical form;
the active substances, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a particular volume or weight;
excipients list;
route of administration;
special warning that the product must be kept out of the reach and sight of children;
date of expiry (month and year);
special storage requirements;
special precautions related to the disposal of unused medicinal products and waste materials;
name and address of the marketing authorization holder and its local representative, as the case may be;
marketing authorization number;
manufacture batch number;
instructions for use, for OTC medicinal products;
safety precautions, where applicable.

The label of the medical devices should mention:

the name/trade name and address of the manufacturer; for the devices imported in the European Union in view of trade, the name and address of the authorized representative of the non EU-manufacturer should be mentioned on the label;
CE mark-up;
the details strictly necessary for the user to identify the medical device and the content of the package;
the claim “sterile”, if the case;
the lot number or the serial number of the device preceded by the words “LOT NUMBER” or “SERIAL NUMBER” or an equivalent symbol, as appropriate;
an indication of the date (year and month) by which the device could be safely used, as the case may be;
an indication that the device is for single use, as the case may be;
the claim „custom-made device”, in case of custom-made devices;
the claim „exclusively for clinical investigation”, if the device is intended for clinical investigations only;
special storage and/or handling conditions;
special instructions for use;
warnings or safety precautions, as the case may be;
year of manufacture, for active devices;
sterilization method, if the case;
statement that the device contains a derivative of human blood, if the case.

15. What additional information may be included in labeling and packaging?

The primary and the secondary package of medicinal products may provide for the following additional information:

graphic symbols and icons designed to clarify certain information included in the labeling and patient information leaflet;
other specifications compatible with the summary of product characteristics, which might prove useful to the patient, provided that any advertising intended element is excluded;
a translation in one or more languages besides Romanian, bearing in mind that the information provided must be identical in all the languages used.

Medical devices

In certain cases, the information provided by the manufacturer can be in the form of symbols. Any such symbol or identification color used shall be in compliance with the European harmonized standards. Where there are no such standards, the symbols and colors used shall be described in the documentation provided for the medical device.

Also, if the intended purpose of the device is not obvious to the user, the manufacturer must clearly mention it on the label, as well as in the instructions for use.

16. What items may not be included in labeling and packaging?

By law, the information included on the labeling and packaging of the medicinal product shall not include elements which entail an advertising purpose. Also, the restrictions regarding misleading and comparative advertising, unfair practices and consumer protection should apply accordingly.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Medicinal Products:

As a general rule, the information provided for advertising purposes must be in accordance with the summary of product characteristics and, as a general rule, shall not be comparative or misleading. The competent authority in this fields is NAMMD.

By law, the advertisement for a medicinal product:

should be accurate, balanced, equitable, objective and complete to enable those to whom it is addressed to form their own opinion on the therapeutic value of the medicinal product in question;
should be based on an up-to-date assessment of all relevant evidences and clearly reflect such evidences;
should encourage the rational use of the medicinal product, without exaggerating its therapeutic properties;
should not encourage self-medication or the unreasonable use of the medicine;
should not be misleading, subliminal or misleading by distortion, exaggeration, unjustified accentuation, omission or any other way;
should not suggest that a medicinal product or an active ingredient has any merit, quality or special property if this cannot be scientifically documented;
should not prejudice respect for human dignity;
should not include discrimination based on race, gender, language, origin,
social origin, ethnicity or nationality;
should not harm the image, honor, dignity and private life of individuals.

In addition to the above mentioned requirements, the Advertising Norms provide certain restrictions for the advertising addressed to the general public, such as the prohibition to advertise medicinal products:

without marketing authorization in Romania;
without the approval of NAMMD, where such is required;
released only based on medical prescription;
containing narcotic or psychotropic substances;
prescribed and released in the health insurance system, with the exception of vaccination campaigns performed by the pharmaceutical industry and approved by the Ministry of Health.

It is also prohibited to include in the advertisement information suggesting, inter alia, that:

proper medical consultation or surgical intervention is not necessary, especially by offering diagnosis or long distance treatment suggestions;
the medicinal product has a guaranteed effect and is not likely to cause adverse reactions;
the patient’s overall health can be improved only by using the advertised medicinal product;
emphasizes a certain recommendation from healthcare professionals whose celebrity could encourage the consumption of such medicinal products.

Medical devices:

The applicable legislation regulates a specific procedure for the authorization by NAMMD, as competent authority, of the advertising materials for medical devices and provides for certain rules and limitations regarding the advertising and promotion of such products:

In case of promotion to the public:

Medical devices companies will be able to promote to the public only the medical devices which could be used without medical intervention. The advertising materials designed for the public should be approved in advance by the NAMMD, based on the request of the device’s manufacturer, importer, or local distributor. By law, the NAMMD should assess the advertising materials within 30 days of the request.

The advertising materials should not be misleading, should present accurate, verifiable, updated, and complete information for the target audience consistent with the user manual, and the claims regarding the product’s intended use and its benefits should be backed up by relevant scientific proof.

In case of promotion to the healthcare professionals:

Advertising materials intended for healthcare professionals should contain specific information concerning the medical device and should comply with certain requirements. Such materials should expressly indicate that they are designed exclusively for healthcare professionals and provide a minimum level of information regarding the medical device’s name, indications, class, and details regarding proper use.

The NAMMD is empowered to perform compliance checks on material designed for healthcare professionals, even if the company producing that device or material was not required to obtain the NAMMD’s authorization before using the material on the Romanian market.

Furthermore, the Ministry of Health recently published the draft advertising norms for medical devices which provide, among other relevant aspects, the main rules in connection with:

misleading and comparative advertising, the rational use and the conformity of the medical devices;
promotion of medical devices to the healthcare professionals;
promotion of medical devices to the public;
evaluation and monitoring of all forms of advertising of medical devices;

The new advertising norms for medical devices are expected to enter into force in 2022.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicinal products:

As a rule, medicinal products are sold and released to the patients by the open circuit (community) pharmacies or by the closed circuit pharmacies, at the authorized premises of such pharmacies. In order to supply medicines to the patients, the pharmacy needs to be authorized by the Ministry of Health.

According to the Pharmacy Law no. 266/2008, as republished and further amended, certain community pharmacies could be authorized to sell OTC medicinal products online, based on a special authorization to be issued by the Ministry of Health. The secondary legislation issued by the Ministry of Health in 2019 lays down the procedure and the requirements for setting up and operating online pharmacies. Currently, there are several online pharmacies authorized and functioning in Romania.

Medical devices:

Medical devices can be sold via various distribution channels, meaning that they can be acquired in pharmacies, in hospitals and on the internet, from the entities authorized to supply such products. The delivery via post is possible, provided that the transportation ensures the observance of the applicable distribution requirements (e.g., handling, storage, temperature), as the case may be.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

Medicinal products:

Internet advertising for medicinal products includes webpages, e-mails, forums, blogs or any other form of electronic support (except for social networks or Android, iOS or any other mobile application).

Activities which entail using internet as a platform for advertising medicinal products to the public require the prior approval of NAMMD. The concerned webpages should contain, amongst others, the following information:

identity and address of the owner of the webpage;
complete references on the source of every medical information within the webpage;
the target audience of the webpage;
the number of the advertising visa and date of issuance;
relevant information for investors, media and general public, including financial data, descriptions of research and development programs, a list of all available products;
non-promotional information on health education, characteristics of the diseases concerned, prevention, screening and treatment methods, as well as other information aimed at promoting public health;
relevant aspects of therapeutic alternatives, including, where appropriate, surgery, diet, behavioral modification and other interventions that do not require the use of medicines;
the latest approved information, package leaflet and summary of product characteristics (SmPC) of the advertised medicines;
non-promotional aspects for patients and for the general public with regard to the OTC portfolio of the pharmaceutical company;
ink the public assessment report(s) issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use or by a competent national competent authority;
recommendation to consult a healthcare professional for further information.

It is prohibited to advertise medicinal products through e-mail, mobile phones (SMS), mobile apps (for example, Android or iOS) or social networks.

Advertising of prescription based medicines via internet to healthcare professionals is permitted provided that:

• the marketing authorization holder proves that access to such information is restricted to persons other than health professionals through a valid and verifiable password system; the information provided must contain the full SmPC;
• website providers must ensure that the materials posted on the website do not contain information inconsistent with applicable national and international regulations.

Medical devices:

The audiovisual regulations provide for certain limitations on the advertisement of medical devices on TV and on radio. Amongst others, it is forbidden:

to advertise a medical device released based on medical prescription;
to broadcast advertising materials where healthcare professionals, medical
associations or pharmacists recommend the use of such products;
to broadcast advertising materials in TV shows for children or during the commercial breaks preceding or subsequent to the broadcast of such shows.

The draft advertising norms for medical devices, published by the Ministry of Health in 2022 for public consultations, expressly mention internet advertising (excluding social media or mobile applications) as a form of advertising for medical devices. According to the advertising norms, the advertising materials promoted on the internet should comply with the same rules and conditions as any other form of advertising for medical devices.

The draft advertising norms also provide, among others, that:

in case of promotion to healthcare professionals: (i) the company should prove that a valid and verifiable system is in place in order to restrict the access to information of people other than healthcare professionals; (ii) the website providers should ensure that the published materials do not contain information that contravenes national and international advertising regulations in force;
as a rule, all forms of internet advertising for medical devices should be evaluated and authorized by NAMMD;
the advertising of medical devices through e-mail, mobile (including text messages) or through the social media is forbidden.

20. May medicines and devices be advertised or sold directly to consumers?

OTC medicinal products may be advertised to the public, subject to certain restrictions, as mentioned at Chapter 3 Question 17 above.

Medical devices can be advertised and sold directly to consumers, by observing the applicable legal requirements referred to in the sections above.

In all cases, both for medicines and for medical devices, it is prohibited to use misleading or comparative claims, as well as unfair commercial practices.

21. How is compliance monitored?

NAMMD is the main authority in Romania monitoring and ensuring compliance with the regulatory provisions on medicines and medical devices.

Thus, NAMMD is competent to monitor compliance with the legal requirements set for the marketing, manufacturing, packaging and labeling, as well as advertising and promotion of medicinal products and medical devices.

In this respect, NAMMD, among others, carries out inspections, issues authorizations and approvals for the purpose of manufacturing, marketing, labeling and advertising for such products, issues guidelines, norms and decisions, supervises and controls the quality of medicinal products and medical devices, applies sanctions in case of breach.

22. What are the potential penalties for noncompliance?

Depending on the type of infringement, NAMMD, National Consumer Protection Agency, the Ministry of Finance, the Romanian Audiovisual Council can apply various fines and sanctions, including the suspension, withdrawal or cancellation of certain authorizations, and the withdrawal from the market of certain products.

By way of example, the non-compliance with the requirements of the law on advertising medicinal products constitutes a minor offence which can trigger an administrative fine ranging between RON 10,000 (roughly EUR 2,000) and RON 30,000 (roughly EUR 6,000). This fine can be applied to the manufacturer, importer, wholesale or retail distributor.

The breach of the legal requirements on advertising medical devices constitutes a minor offence which can trigger an administrative fine ranging between RON 2,000 (roughly EUR 400) and RON 20,000 (roughly EUR 4,000). In addition, NAMMD may apply various sanctions for the failure to comply with the legal provisions, including having the medical device withdrawn from the market, being prohibited from using the medical device or placing it on the market, and having the authorizations held by the medical-device importers and distributors withdrawn or suspended.

According to Government Ordinance no. 2/2001, the following additional (complementary) sanctions might be applied by the competent authorities in case of offenses: (a) the suspension or, as the case may be, cancellation of the approval/endorsement/authorization for carrying out the activity; (b) the closing of the unit; (c) the blocking of the bank account; (d) the suspension of the activity of the relevant entity; (e) the withdrawal as a temporary or final measure of the license or approval for certain operations; (f) seizure of the goods designated, used or resulting from the contravention. As a rule, the sanctions provided by GO no. 2/2001 could be applied depending the gravity of the offense and by taking into account the circumstances of the deed, the means and the purposes of the offense, the consequences, as well as the background of the relevant offender.

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11. Preclinical & Clinical Trial Requirements: Romania

An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.

2. How are clinical trials funded?

A clinical trial is normally financed by its sponsor, who can delegate certain financial operations to a contract research organization (“CRO”).

The payments made by the sponsor and/or the CRO are used for the financing of all activities for implementing the trial in accordance with its protocol, including without limitation, for the payment of the fees of investigators and of the services performed by healthcare institutions.

The financing of the clinical trial and the relevant agreements to be concluded with the investigators and with the institutions are assessed by NAMMD / Ethics Committee, when submitting the application for performing the clinical trial in Romania.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

According to the applicable regulations, the clinical trial protocol should provide:

general information regarding the sponsor, investigators and laboratories;
certain information regarding the investigated product, its use and the target population;
the clinical trial’s objectives;
the selection and withdrawal of the subjects;
the treatment administered to the subjects;
the evaluation of the trial’s efficacy and safety;
statistical information;
quality assurance and quality control provisions;
ethical aspects;
data processing aspects;
financing, insurance and certain other aspects provided by the clinical trial guidelines.

In order to perform clinical trials in Romania, it is required to obtain an authorization from the National Agency for Medicines and Medical Devices (“NAMMD”) and the favorable opinion of the National Bioethics Committee for Medicinal Products and Medical Devices (“NBCMMD”), which shall assess, inter alia, the clinical trial protocol.

As part of the authorization procedure, NBCMMD should issue a prior opinion on the trial and its protocol. Any major amendment to the clinical trial protocol should be approved by NBCMMD and the NAMMD, before its implementation.

4. What are the requirements for consent by participants in clinical trials?

Subjects participating in clinical trials should give their written, dated and signed consent, willingly expressed after receiving adequate information concerning the nature, significance, possible consequences and risks of the trial, before their inclusion in the trial.

In the case of minors and persons unable to give an informed consent, it is their legal representative’s responsibility to provide the required consent. Also, if the trial subject is unable to write, they can verbally give the consent in the presence of at least one witness.

The clinical trial subjects have the right to withdraw their written consent anytime, at their sole discretion.

5. May participants in clinical trials be compensated?

Clinical trial subjects cannot be paid or receive other financial advantages for their participation in clinical trials. Certain limited expenses, such as travel costs, could be reimbursed in accordance with the clinical trial protocol.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The protection of clinical trial subjects is ensured by adequate medical supervision, aimed at identifying and reporting any adverse reactions and other issues during the clinical trial. The reports on adverse reactions are submitted with the regulatory authorities.

In order to indemnify the subjects, the sponsor should conclude an insurance agreement with an insurance company, otherwise NAMMD shall not approve the performance of the clinical trial in Romania.

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12. Regulatory, Pricing and Reimbursement: Romania

The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The regulatory authorities competent in these fields are:

the Ministry of Health (http://www.ms.ro/);
the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and
the National Health Insurance House (http://www.cnas.ro/).

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The main enactment in the pharmaceutical and healthcare fields in Romania is Law no. 95/2006 on healthcare reform, as republished and further amended and supplemented (the “Health Law”), which regulates, amongst others:

for medicinal products (including biologicals): the marketing authorization, manufacturing, import, distribution, labelling, advertising, promotion and pharmacovigilance activities;
for medical devices: the trade, distribution and the performance of certain services and activities.

The secondary legislation consists of Government Decisions, Government Ordinances, Orders, Decisions and Norms issued by the Ministry of Health, the National Agency for Medicines and Medical Devices (NAMMD) and the National Health Insurance House (NHIH), such as:

A. Marketing Authorization:

Ministry of Health’s Order no. 1448/2010 approving the Regulations regarding the marketing authorization and supervising of medicinal products for human use;
Emergency Ordinance no. 46/2021 on establishing the institutional framework and the measures for implementing Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Government Decision no. 54/2009 on the conditions for the trade of medical devices;
Government Decision no. 798/2003 on the conditions for the trade and use of in vitro diagnostic medical devices;
Ministry of Health’s Order no. 1009/2016 on the registration of medical devices in the national database.

B. Distribution:

Government Decision no. 696/2021 for the approval of services packages and of the Framework Agreement on the conditions of providing medical assistance, medicines and medical devices within the social health insurance system for 2021-2022;
Government Decision no. 423/2022 for the approval of national health programs;
Government Decision no. 720/2008 for the approval of the List of international non-proprietary names (INNs) of medicines out of which insured persons benefit with or without personal contributions, based on medical prescription, within the social health insurance system, and of the international non-proprietary names of medicines provided under the national health programs.

C. Pricing

Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use.

D. Reimbursement

Government Decision no. 140/2018 for the approval of services packages and of the Framework Agreement on the conditions of providing medical assistance within the social health insurance system for 2018-2019;
Government Decision no. 155/2017 for the approval of national health programs for 2018 and 2019;
Government Decision no. 720/2008 for the approval of the List of international non-proprietary names (INNs) of medicines out of which insured persons benefit with or without personal contributions, based on medical prescription, within the social health insurance system, and of the international non-proprietary names of medicines provided under the national health programs.

3. What are the steps to obtain authorization to develop, test, and market a product?

A. Medicinal products (including biologicals):

In order to perform clinical trials on medicinal products for human use, it is necessary to obtain the authorization of the National Agency for Medicines and Medical Devices (“NAMMD”) and the favorable opinion of the National Bioethics Committee for Medicinal Products and Medical Devices (“NBCMMD”). The laboratories and the other units performing the tests should be duly authorized by NAMMD and by the Ministry of Health and/or the competent health department.

To trade a medicinal product on the Romanian market, it is necessary to obtain a marketing authorization and a price approval order for the respective product.

The marketing authorization is issued either:

at national level, by NAMMD, under the national evaluation procedure or under the mutual recognition or decentralized procedures; or
at centralized level, by the European Medicines Agency (“EMA”).

The authorization procedure should be completed within a maximum of 210 days from the date of filing of a valid application. During this procedure, the regulatory authority shall assess, amongst others, the results of the pharmaceutical and pre-clinical tests, as well the results of the clinical trials.

After obtaining the marketing authorization, the medicine’s price should be approved by the Ministry of Health. By law, the Ministry should issue an order approving the medicine’s price within 90 days from the date of filing of the price application dossier.

The prices of medicinal products (i.e., the manufacturer price and the maximum wholesale and retail prices) are published in the National Public Catalogue (the “Public Catalogue”) and in the National Catalogue of the Prices of Medicinal Products Authorized for Marketing in Romania (also known as the “CANAMED”).

The entities performing the manufacturing, the import, the wholesale distribution or the retail distribution activities should be duly authorized for performing such activities. In Romania, the manufacturing, the import and the wholesale distribution authorizations are issued by NAMMD, while the pharmacy license is issued by the Ministry of Health.

Furthermore, certain medicinal products, including the ones having in their composition psychotropic and narcotic substances, are subject to special authorization, distribution and prescription rules.

B. Medical devices:

Medical devices should have the CE marking in order to be traded in Romania. An additional registration step is the inclusion of the medical device in the National Database of Medical Devices, held by NAMMD.

The entities performing the manufacturing, the import, the wholesale distribution and the retail distribution activities should be duly authorized by NAMMD.

4. What are the approximate fees for each authorization?

A. Medicinal products (including biologicals):

The administrative fees for the marketing authorization of a medicinal product under the national procedure are EUR 5,000 (paid when the marketing authorization dossier is submitted with NAMMD) plus EUR 9,500 (due for the evaluation of the marketing authorization dossier).

The fees are generally lower for the evaluation of generic medicines (e.g., EUR 5,700), for biosimilars (e.g., EUR 6,650), and for medicines authorized under the mutual recognition and/or decentralized procedure. The exact value of the fees are determined by NAMMD by taking into account the particular situation of each product.

B. Medical devices:

There is no administrative fee for the registration of medical devices by NAMMD in the National Database of Medical Devices.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

A. Medicinal products (including biologicals):

By law, the marketing authorization issued by NAMMD is valid for 5 (five) years.

In view of its renewal, the marketing authorization holder should submit to NAMMD, not later than 9 (nine) months before the expiry date:

a consolidated version of the dossier on the quality, safety and efficacy, an evaluation of data in the reports on suspected adverse reactions and the updated periodic safety reports;
the variations which occurred after the issuance of the marketing authorization.

After its renewal, the marketing authorization is valid for an unlimited period, unless NAMMD decides to renew it for an additional five-year term only, due to pharmacovigilance-related reasons.

B. Medical devices:

The registration of medical devices in the National Database of Medical Devices is valid for an unlimited period, as long as there is no change which would require the amendment of the registration. Pursuant to the latest changes in the national legislation, the functioning authorization issued by NAMMD for the companies which import or distribute medical devices shall be valid, as a rule, for a of 3 (three) years period.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The marketing authorization procedure for generic products is simplified, compared to the procedure for the innovative (brand-name) medicinal products.

Thus, after 8 (eight) years from the issuance of the marketing authorization of an innovative medicinal product, its generic can apply for marketing authorization without supplying the results of the pre-clinical tests and of the clinical trials. To this end, the generic applicant should prove that the reference innovative product was authorized for at least 8 years in Romania, in the European Union under the centralized procedure or in another EU Member State.

In such case, the generic product cannot be placed on the market until 10 years have passed from the initial authorization of the reference innovative product.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?

By law, in the case of combinations between a medical device and a medicinal product:

the device shall be deemed a medical device, if it is designed for administering a medicinal product; in this case, the administered product is subject to the medicines’ regulations;
the combination product shall be subject to the regulations applicable to medicines, if such device is placed on the Romanian market as a single, complete product, exclusively intended to be used in the given combination.

For the marketing authorization of medicinal products containing a combination of active substances which are in the composition of certain authorized medicines, but have not yet been used in such combination for a therapeutic purpose, it is necessary to submit the results of new pre-clinical tests and clinical trials for the respective combination.

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

NAMMD is the competent regulatory authority that monitors the medicines placed on the Romanian market and the activities carried out by the pharmaceutical companies, manufacturers, distributors, importers and exporters of medicines. In this respect, NAMMD:

performs quality assessments on the authorized medicinal products, carrying out inspections at manufacturing and distribution facilities and other monitoring activities;
supervises the pharmacovigilance activities designed to collect information on the risks of medicinal products placed on the market;
requires post-authorization safety assessments, if there are concerns about the risks of certain medicinal products;
performs inspections for ensuring the compliance with the guidelines on good manufacturing practices and with the guidelines on good distribution practices;
applies various fines and sanctions, including the suspension and the with drawal of certain medicinal products from the market, and the suspension and the withdrawal of the authorizations of the entities in breach of the pharmaceutical legislation.

In view of monitoring compliance in the medical devices field, NAMMD:

performs periodic audits and evaluations regarding the medical devices placed on the market, and other activities for supervising the activities in this field, as well as inspections at the premises of the entities involved in the medical devices activities;
applies various fines and sanctions to the entities and persons in breach of the medical devices legislation.

9. What is the potential range of penalties for noncompliance?

According to the Health Law, failure to observe the legislation in the pharmaceutical and healthcare fields can trigger the disciplinary, civil, administrative or criminal liability, depending on the circumstances of each case.

In the pharmaceutical field the authorities may apply fines, ranging between RON 10,000 (roughly EUR 2,000) and RON 100,000 (roughly EUR 20,000) per breach, as well as other sanctions, such as:

the suspension, withdrawal or cancellation of the authorization; and
the withdrawal of the product from the market.

In the medical devices field, the fines range between RON 2,000 (roughly EUR 400) and RON 20,000 (roughly EUR 4,000) per breach.

When applying a fine or other main sanction, the authorities are entitled to apply additional (complementary) sanctions, such as: (a) the suspension or, as the case may be, cancellation of the approval/endorsement/authorization for carrying out the activity; (b) the closing of the unit; (c) the freezing of bank accounts; (d) the suspension of the activity of the relevant undertaking; (e) the withdrawal as a temporary or final measure of the license or approval for certain operations; (f) seizure of the goods used or resulting from the offence.

10. Is there a national healthcare system? If so, how is it administered and funded?

The Romanian public health insurance system is coordinated at national level by the National Health Insurance House (“NHIH”), which has in its subordination 42 local public health insurance houses.

NHIH has, among others, the following responsibilities:

proposing, with the prior notice of the Ministry of Health, legislative measures for ensuring the proper functioning of the health insurance system;
approving the regulations on the collection, management and control of
the social health insurance fund;
drawing up and updating of the registries of insured patients;
guiding and monitoring the enforcement of the regulatory provisions by the local health insurance houses;
drafting the national framework agreement regarding the provision of medical assistance in the social health insurance system;
elaborating forecasts, strategies, studies and analyses on the development and functioning of the health insurance system in Romania, with the aim of further improving it;
monitoring the reimbursement of medicinal products;
preparing the lists of medicinal products (trade names) reimbursed within the social health insurance system, in line with the health technology assessments made by NAMMD and the Government’s decisions.

The financing of the Romanian health insurance system is ensured by mandatory contributions to the public health insurance system by individuals and legal entities, which are collected in the National Sole Social Health Insurance Fund (“NSSHIF”), managed by the NHIH.

The NSSHIF is used for funding the entire public health insurance system, including the national health programs, for providing medical services, medicinal products and medical devices to insured individuals.

Other financing sources include grants from the state budget and from the budget of the Ministry of Health and local authorities, and donations and sponsorships made by individuals and legal entities.

Moreover, pharmaceutical companies pay a clawback tax for certain medicines traded on the local market, which is also meant to cover the financing of the public health insurance system.

11. How does the government (or public) healthcare system function with private sector healthcare?

In Romania, public and private healthcare providers operate in parallel.

The insured patients can receive medical services, in the public health insurance system, either:

in public healthcare units; or
in private healthcare units, which have concluded reimbursement agreements with the competent health insurance house (i.e., the NHIH or a house in its subordination).

12. Are prices of drugs and devices regulated and, if so, how?

The price of: (a) medicinal products released based on medical prescription (Rx medicines) and (b) over-the-counter medicinal products (OTC medicines) prescribed to patients in the social health insurance system, has to be approved by the Ministry of Health. The price of other OTC medicines can be established independently by their marketing authorization holders.

To obtain the price approval, the medicine’s marketing authorization holder should submit an application to the Ministry of Health, together with certain documents regarding the prices of the same product in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.

As a rule, the manufacturer price proposed by the marketing authorization holder for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in the 12 comparison countries. However, the price of immunologic medicines and of medicines derived from blood or human plasma (e.g., albumin, coagulation factors and human immunoglobulin) should be lower than or (at most) equal to the average of the lowest 3 (three) prices of the same product in the 12 comparison countries. If the medicine has a price approved in only one of the 12 comparison countries, the price proposed for Romania should be lower than or (at most) equal to the price in the respective country. If there is no price approved in any of the 12 comparison countries, the price for Romania could be approved at the level proposed by the marketing authorization holder or its representative.

The price of generic medicinal products should be lower than or (at most) equal to the generic reference price, which is set at a value representing 65% of the price of the reference innovative medicinal product, while the price of biosimilars should be lower than or (at most) equal to the biosimilar reference price – representing 80% of the price of the reference innovative medicine.

As a rule, the price of off-patent innovative medicines should be lower than or (at most) equal to the generic reference price or, as the case may be, the innovative reference price, depending on the patent expiry date.

The medicines’ pricing norms provide for an exception to the 65% referencing rule, in case of the medicines approved for the first time in the CANAMED price catalogue and for the ones which fall under the following category: the only medicine having a certain international non-proprietary name (INN), strength and pharmaceutical form included in the CANAMED. For such products, the 12-country comparison will apply, however their price shall not be reduced according to the 65% referencing rule.

According to the pricing norms, the prices of medicinal products (including the manufacturer price, as well as the maximum wholesale and retail prices) should be approved within 90 days, and should be published by the Ministry of Health in an order approving the price catalogue.

If a medicine is reimbursed in the national health insurance system, its reimbursement price shall be approved according to certain specific rules applicable to each reimbursement list.

The price of medical devices is not regulated. However, in the case of reimbursed medical devices, their reimbursement value is approved by the Ministry of Health and/or the NHIH.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

Patients insured in the national health insurance system can receive medicinal products and/or certain medical devices from pharmacies which have concluded reimbursement agreements with health insurance houses, either free of charge or by making a co-payment.

The price of a medicine can be reimbursed at a level of 20%, 50%, 90% or 100%, depending on the reimbursement list where the medicine is included. The list of the international non-proprietary names (“INNs”) reimbursed in Romania is approved by the Government. Based on the INN Reimbursement List, the NHIH and the Ministry of Health issue the lists providing the trade names and reimbursement values applicable for medicinal products in the social health insurance system and the national health programs.

Certain medical devices are reimbursed in the national health insurance system, at a value established by the Ministry of Health and/or the NHIH.

NHIH and the other public health insurance houses in its subordination cover the reimbursed value, by providing the reimbursement amounts to the pharmacies releasing the reimbursed medicinal products and/or medical devices, based on special supply agreements.

The role of private payers in relation to the reimbursement of medicines and/or medical devices is not expressly regulated by the legislation currently in force in the healthcare field.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Medicinal products and medical devices are prescribed by physicians and are dispensed to the patients by pharmacies and hospitals.

As a rule, the insured patients obtain the reimbursed medicines free of charge or with a price reduction from a pharmacy which has previously concluded a supply (reimbursement) agreement with the NHIH or with the local health insurance house.

Thus, pharmacies in a contractual relationship with the health insurance houses are entitled to be reimbursed the counter value of the medicinal products that were previously dispensed to the patients. To this end, pharmacies submit reimbursement data for each month, to the competent health insurance house. The health insurance house should pay the pharmacies the reimbursement amounts within 60 days of submitting the relevant documentation.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

According to applicable legislation, the prescribing physicians have various obligations related to patient care, information and safety, among which:

to observe the confidentiality of the patients’ medical data;
to inform the patient on the purpose and nature of the medical intervention, as well as on the consequences and risks of such procedure, to ensure that every medical intervention is performed based on the informed consent of the patient or their representative;
to comply with the anti-bribery and conflict of interest obligations, and not to receive any sponsorships or improper advantage meant to influence their medical decision;
to declare the sponsorships received from pharmaceutical and medical devices companies to NAMMD, which will make such information available to the public.

The medicines are usually prescribed by their international non-proprietary name, and not their trade name (except for biologicals and certain other products), by using the electronic prescription form.

The pharmacists dispensing the medicinal products and medical devices to the patients are obliged to ensure the confidentiality of the medical data and to provide adequate information to the patients regarding the relevant products. If the physician prescribes a certain international non-proprietary name (and does not mention the medicine’s trade name), the pharmacist should first recommend the cheapest product having the respective international non-proprietary name.

The pharmacists should comply with certain conflict of interests and incompatibilities obligations set forth by the applicable legislation.

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