The Pharma Legal Handbook: Slovakia

The legal framework for orphan drugs and rare diseases in the Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

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

The Slovak legislation does not have a specific legal definition for Rare Diseases. The Slovak Act on Medicinal Products rather refers to the Regulation (EC) No. 141/2000 with respect to rare diseases.

 

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

Yes, this designation exists in Slovakia. However, as described in our answer to question No. 1 above, the Slovak legislation refers to the Regulation (EC) No. 141/2000 with respect to the definition of rare diseases.

 

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?)

There is no specific regulatory framework for the authorization of Orphan Drugs in Slovakia. According to the Annex to the Regulation (EC) No. 726/2004, medicinal products that are designated as orphan medicinal products developed are authorized through the centralized procedure (the respective marketing authorization is issued by the European Commission and is valid for all EEA member states).

 

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

As stated above, there is no specific regulatory framework for the authorization of Orphan Drugs in Slovakia and related requirements and all orphan medicinal products are authorized through the centralized procedure.

No relaxed clinical trial or scientific evidence requirements in respect of Orphan Drugs are provided by the EU legislation. However, the EU offers other “incentives” to encourage the development of Orphan Drugs by way of, e.g. scientific advice, “protocol assistance” (a type of scientific advice relating to the criteria for authorization of an orphan drug), market exclusivity, possibility of administrative fees reduction (depending on the status of the sponsor and the type of service required).

 

5. Is there an expedited pathway for Orphan Drugs?

According to the European Medicines Agency, orphan medicinal products will not automatically qualify for accelerated assessment (150 days, instead of 210 days for the opinion of the Committee for Medicinal Products for Human Use). However, an accelerated evaluation might be initiated by the CHMP in exceptional cases when a medicinal product is intended to meet a major public health need.

 

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

In general, foreign marketing authorizations are not valid in the Slovak Republic and authorization of local authorities is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states. Please also refer to Answer No. 6 to Chapter 3: Marketing, Manufacturing, Packaging & Labelling, Advertising.

 

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

In Slovakia, there is no specific reimbursement regulation related to the orphan drugs. Reimbursement of orphan drugs is regulated by the same legislation as the Reimbursement of other medicinal products. Please refer to Answers Nos. 12 and 13 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview. Only a part of the orphan drugs is currently fully reimbursable from the Slovak public health insurance system.

 

8. How are the prices of Orphan Drugs regulated?

In Slovakia, there is no specific pricing regulation related to the orphan drugs. Pricing of orphan drugs is regulated by the same legislation as the pricing of other medicinal products. Please refer to Answer No. 12 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.

 

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

For the calculation of the “European reference price of a medicinal product”, the average price comparison of three lowest prices in other (only) EU countries is used.

 

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

No.

 

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?

No.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

The legal framework for biosimilars and biologics in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

Biosimilar medicines are not considered the same as generic medicines in Slovakia. A similar biological medicinal product, also known as “biosimilar”, is a product which is similar (not identical) to a biological medicinal product that has already been authorised in the EAA, a so-called “reference medicinal product”.

The active substance in case of biological medicinal products is made from living organisms. As a result, there may be some minor differences from the reference medicinal product; natural variability is inherent to all biological medicinal products. However, these minor differences are not clinically meaningful, i.e. no differences are expected in safety and efficacy.

 

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

In general, any invention that meets the requirements of novelty, inventive step and capability of industrial application can be patented under Slovak patent law. The Slovak patent law addresses also biotechnological inventions which are also patentable, even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used, including inventions which concern:

• 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;
• microbiological or other technical process or a product obtained by means of such a process; or
• 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, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

There are certain inventions which are excluded from the patentability under Slovak patent law e.g., inventions relating to the human body at various stages of development, invention which commercial use would be contrary to public policy or good manners (in particular, methods of human cloning, use of human embryo for industrial or commercial purposes).

Should the biologic medicine fulfil the statutory requirements outlined above, it should be patentable under Slovak law. Given the nature of biosimilar medicines in terms of their high similarity to biological medicinal products, their patentability seems to be rather questionable. Although a different element related to the biosimilar medicine (e.g. a difference in the production process of the biological material) can fulfil the criteria of an invention under the Slovak patent law, it should be carefully assessed from the perspective of the process of obtaining the marketing authorization during which the highly similarity of the biosimilar medicine must be proved.

 

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?

The Act on Medicinal Products basically states in connection with the marketing authorization of biosimilar medicines that the applicant is required to submit the results of the relevant toxicological and pharmacological test and the clinical trials related to the differences between the “reference” biological medicinal product and biosimilar medicines; it is not necessary to submit the results of toxicological and pharmacological test and the clinical trials already carried out in relation to the reference biological medicinal product.

Otherwise, there is no specific regulatory framework for the marketing authorization of biosimilar medicines in Slovakia. According to the Annex to the Regulation (EC) No. 726/2004, medicinal products developed by means of biotechnological processes and medicinal products for treating of specific diseases (e.g. auto-immune diseases), basically most of the biosimilar medicines, are authorized through the centralized procedure (the respective marketing authorization is issued by the European Commission and is valid for all EEA member states).

 

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?

As discussed in Answer No. 3 above, most of biosimilar medicines are authorized through the centralized procedure by the European Commission. The European Medicines Agency has issued several guidelines on biological medicinal products and Q&As to assist developers prepare marketing authorisation applications.

According to the European Medicines Agency, the development of biosimilar medicines relies heavily on comparability studies to establish (high) similarity to the reference product, whereas comparability is conceived as a stepwise process that is tailor-made for each product. When assessing the marketing authorisation applications for biosimilars, the applicants must thus mainly demonstrate this similarity through comprehensive comparability studies with the reference product.

The respective data and documentation to be provided by the applicant are specified in Directive 2001/83/EC, in particular in Annex No. 1 which is supplemented by sections containing additional special requirements for biological medicinal products (e.g. with respect to toxicological and pharmacological tests, the requirements may have to be adapted for individual biological medicinal products).

 

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

According to the Guideline on similar biological medicinal products of the European Medicines Agency, the reference medicinal product must be a medicinal product authorised in the EEA, on the basis of a complete dossier in accordance with the provisions of Article 8 of Directive 2001/83/EC. Further, according to the Regulation (EC) No. 726/2004, the medicinal products for human use (including the biological medicinal products) which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data exclusivity and a ten-year period of market exclusivity (this period can be extended to a maximum of 11 years).

 

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

The Guideline on similar biological medicinal products of the European Medicines Agency provides for an exemption in order to facilitate the global development of biological medicinal products and to avoid unnecessary repetition of clinical trials. Under this exemption, it may be possible for the applicant to compare the biological medicinal products in certain clinical studies and in in vivo non-clinical studies with a non-EEA authorised version of the reference medicinal product which will need to be authorised by a regulatory authority with similar scientific and regulatory standards as European Medicines Agency (e.g. ICH countries). However, it will be the applicant’s responsibility to demonstrate that the comparator authorised outside the EEA is representative of the reference product authorised in the EEA.

 

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

There is no special legislation for the regulation of the prices of biosimilar medicines nor original biological drugs. In Slovakia, the Slovak Ministry of Health is the competent authority, among other matters, for the pricing and categorization of the medicinal products.

Under the Slovak special pricing legislation, ERP is used when setting the prices of medicinal products in order to be registered into the “List of medicinal products with officially determined price” or “List of categorized medicinal products”. Generally, the “European reference price of medicinal product” cannot be exceeded when setting the price of a medicinal product. For the calculation of the “European reference price of a medicinal product”, the average price comparison of three lowest prices in other EU countries is used.

 

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

There is no special legislation for the reimbursement policy of biosimilar medicines nor original biological drugs. In Slovakia, the Slovak Ministry of Health is the competent authority, among other matters, for categorization of the medicinal products.

Medicinal products in general with officially determined price are fully reimbursable from the public health insurance system only when administered within hospital care (uninterrupted health care for more than 24 hours). In order to become (partially or fully) reimbursable from the public health insurance system also when administered within out-patient care or when dispensed by pharmacies, the respective medicinal product must be listed in the “List of categorized medicinal products”. Please also see our answer to question No. 7 above.

 

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

As indicated our answers to questions Nos. 10 and 11 below, the biological medicinal products are practically excluded from the substitution given their nature based on similarity. Having said that, the biosimilar competition does not seem to have an impact on the reimbursement policy of the original (reference) biologicals.

 

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?

In general, the physician is responsible for the correct choice of the active substance or the medicinal product when prescribing a medicinal product to the patient. In case of medicinal products (fully or partially) reimbursable from the public health insurance, the physician is obliged prescribe the medicinal product by way of stating, among other details, “only” the respective active substance (without specifying the brand name of the respective medicinal product). However, the physician may also specify the brand name of the respective medicinal product, along with the specification of the respective active substance. On the pharmacy level, the pharmacist is obliged to inform the patient on the possibility of the substitution which can be dispensed based on the respective medical prescription and on the amount of the surcharge. However, this legislation does not specifically consider biological medicinal product or biosimilars.

 

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

As specified in our answer to question No. 10 above, in Slovakia, the physician is responsible for the correct choice of the active substance or the medicinal product when prescribing a medicinal product to the patient. Further, the legal definition of the drug substitution encompasses only the medicinal products with the identical active substance, and thus it is conceived for the generic substitution. So, basically the prescription of biosimilars can be considered as physician-led switching.

 

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?

In Slovakia, there is basically no specific legal framework regarding the post—authorisation requirements, including pharmacovigilance, for biological medicinal products. So, the post—authorisation requirements related to “standard” medicinal products apply also on biological medicinal products, including biosimilars.

 

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?

All medicinal products are carefully monitored after they are placed on the EU market. In addition to such standard monitoring, the European Medicines Agency maintains a list of medicinal products that are under additional monitoring in the EU. This list includes medicinal products authorised in the EU (centrally or nationally authorised) that are being monitored particularly closely by regulatory authorities, including the Slovak State Institute for Drug Control. These medicinal products have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means.

The reason why these medicinal products are being monitored even more intensively then other medicinal products is that there is less information available on them than on other medicinal products (e.g., because they are new to the market or there is limited data on their long-term use). According to the European Medicines Agency, the list includes also biological medicines authorised after 1 January 2011 (it applies to all biological medicinal products including biosimilars).

 

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)

No, in particular due to the fact that biosimilars are rather new to the Slovak market.

 

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?

No.

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

The legal framework for localization in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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?

There are generally not such rules. However, the handling with medicinal products (as defined by the Act on Medicinal Products), in particular the production of medicinal products and wholesale distribution of medicinal products and provision of pharmacy services, requires a special license for the respective activity issued under the Act on Medicinal Products e.g. the authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required for manufacturing of medicinal products. However, the State Institute for Drug Control recognizes the authorization for manufacturing of medicinal products issued by the respective authority of another EEA member state. The same applies to authorizations for wholesale of medicinal products issued by the respective authority of another EEA member state. The authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required also for import of medicinal products from non-EEA countries.

With respect to clinical trials, these also require the approval of the State Institute for Drug Control. Under the Act on Medicinal Products, the sponsor or its representative must have a residency (in case of an individual) or its registered seat (in case of a legal person) in an EU member state. Clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the marketing approval must submit a declaration that the clinical trial performed outside the EEA meets the ethical requirements as required by the Act on Medicinal Products.

 

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

No.

 

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)?

Foreign marketing authorizations are basically not valid in the Slovak Republic and authorization of local authorities (i.e., the State Institute for Drug Control) is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states.

Marketing authorization may be also received within the EEA following simplified procedures, i.e., the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). Still, a separate authorization issued by the State Institute for Drug Control is required. Further, the applicants for the marketing authorization must have their residency or registered seat in the Slovak Republic or in another EEA member state.

 

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)?

No, the pricing process for pharmaceutical products in not impacted by localization policies in Slovakia.

 

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)?

No, the reimbursement of pharmaceutical products in not impacted by localization policies in Slovakia.

 

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)?

No, the access to public tenders in general is not impacted by localization policies in Slovakia.

 

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?

Import tariffs, importation and exportation permits are generally regulated on an EU level, without any complex local rules existing in Slovakia. The authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required for import of medicinal products from non-EEA countries. The State Institute for Drug Control is also involved in case of export of medicinal products (partially or fully) reimbursable from the public health insurance system from the Slovak Republic.

Slovakia offers certain attractive taxation schemes for companies involved in research and development. For example, Slovak tax law enables companies to apply for (an additional) tax base deduction of 200% of R&D costs incurred in the respective tax year. The tax base deduction may be further increased if the funding of R&D activities by the taxpayer intensifies over time.

Slovakia also offers a partial (50%) exemption on incomes from exploitation of IP/IT rights developed in the Slovak territory.

 

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

Slovakia in general offers investment incentives (through either direct subsidies or tax holidays), but without a specific focus on the pharmaceutical sector.

 

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?

No such discussions are currently in place in Slovakia.

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes. In our understanding, Cannabinoid Drugs are medicinal drugs containing active compounds of cannabis (such as THC and CBD) as opposed to psychoactive cannabis per se intended for recreational use.

 

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

The regulatory authority with jurisdiction over Cannabinoid Drugs in the Slovak Republic is the State Institute for Drug Control which is directly controlled by the Ministry of Health.

 

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

No. Authorization and pricing and reimbursement of cannabinoid drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview).

 

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

The only cannabinoid drug that has received market approval in the Slovak republic to date is Sativex oral spray (registration No. 63/0251/12-S, registration holder: GW Pharma (International) B.V., the Netherlands, type of registration procedure: mutual recognition procedure).

Sativex contains extracts from cannabis – cannabinoids (THC and CBD; each 100 microliters of spray contain 2.7 mg of THC and 2.5 mg of CBD). Sativex is used in treatment of multiple sclerosis, specifically for betterment of symptoms related to muscular stiffness (spasticity). Sativex can be prescribed only after other medicine for muscular stiffness proved ineffective.

Treatment by Sativex can be initiated by a physician with specialization in respective medical field (specialist). Before initiation of treatment, specialist must first assess the patient’s medical state (specialist mainly assesses gravity of patient’s muscular stiffness and reactions to previous treatments). After the initial assessment, patient undergoes a 4-weeks testing of Sativex after which the specialist performs additional assessment to determine whether treatment shown intended effects. Treatment by Sativex can continue only after the 4-weeks testing shown significant betterment of spasticity symptoms.

 

5. Who can prescribe Cannabinoid Drugs?

Under the Act on Medicinal Products, cannabinoid drugs can be prescribed by a physician. However, if their prescription is linked to a specialization of the physician in respective medical field (specialist), they can be prescribed only by such specialist. The specialist is required to have a specific numeral code assigned by the Health Care Surveillance Authority and an agreement on provision of healthcare with the health insurance company in which respective patient is insured in place.

Cannabinoid drugs can be also prescribed by a general physician (GP) based on recommendation of a specialist listed in patient’s medical record.

Cannabinoid drugs can only be prescribed on the specific form of prescription labelled by diagonal blue stripe. These forms must be registered. In addition, the physician is obliged to create so-called “prescription record” signed with the qualified electronic signature into the electronic patient’s medical record.

 

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

No. Cannabinoid drugs can be prescribed by any doctor who fulfils the conditions outlined in Answer No. 5 to this article.

 

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

No approvals or notifications are required. Authorized doctors can prescribe cannabinoid drugs to their patients in their own discretion after thorough assessment of medical state of an individual patient. Please also refer to Answers No. 4 and 5 to this article.

 

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

There are few specific rules which must be fulfilled by subjects handling with the cannabinoid drugs. Under the respective legislation, handling with cannabinoid drugs means (inter alia) wholesale distribution of cannabinoid drugs and provision of apothecary care by pharmacies.

Handling with cannabinoid drugs is regulated by the Act on Medicinal Products and the Act on Narcotic and Psychotropic Substances.

Cannabinoid drugs are broadly categorized as drugs containing narcotic and psychotropic substances. Subject can be handling with drugs containing narcotic and psychotropic substances (i.e. also with cannabinoid drugs) solely based on two different authorizations granted by the State Institute for Drug Control (general authorization granted pursuant to the Act on Medicinal Products and special authorization granted pursuant to the Act on Narcotic and Psychotropic Substances):

1. General authorization is necessary for handling with any kind of drugs (not just cannabinoid drugs). Applicant for a general authorization must meet the conditions set out in the Act on Medicinal Products.
2. Special authorization is required when handling with drugs containing narcotic and psychotropic substances – i.e. also with cannabinoid
   drugs. Applicant must fulfil requirements set out in the Act on Narcotic and Psychotropic Substances.

The only organizations authorized to sell cannabinoid drugs to public are the pharmacies which fulfil conditions set out by respective legislation described above. Pharmacies can sell these drugs directly to patients upon presentation of an official medical prescription and verification of the identity of the patient.

Wholesale distribution of cannabinoid drugs can be performed by subjects who fulfil conditions set out by respective legislation described above. Under the Act on Medicinal Products, these subjects can distribute cannabinoid drugs mostly (but not exclusively) to pharmacies and healthcare facilities.

 

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

No. Any pharmacy/wholesale distributor fulfilling conditions outlined in answer No. 8 to this “Chapter 8: Cannabinoid Drugs” is authorized to sell/distribute cannabinoid drugs.

 

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

Yes. Currently, there is a proposal subject to discussions of the Slovak Parliament to amend the Act on Narcotic and Psychotropic Substances. It is being proposed to exclude “Cannabidiol (CBD)” from the list of psychotropic substances since it is neither in the list of psychotropic substances under the Convention on Psychotropic Substances of 1971 nor in the list of narcotics under the Convention on Narcotic Drugs of 1961. As a result, medicinal products containing such substance would be considered as “regular” medicinal products and no special authorisation regarding them would be required. On the other hand, it is being proposed to add certain syntetic cannabinoids to the list of psychotropic substances.

 

11. When are they likely to come into force?

The proposed date of the effectiveness of this amendment is 1 May 2021.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No. Under Medical Cannabis we understand psychoactive cannabis used for medicinal purposes.

In fact, under the Criminal Code, it is illegal to possess, manufacture, import, export, purchase, sell, exchange or procure cannabis under the threat of imprisonment up to 25 years or life imprisonment, depending on amount of cannabis in question and other specific details of particular case. This also includes cannabis intended for medicinal use as the Slovak law does not differentiate between medicinal cannabis and cannabis for recreational use.

 

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

There are no regulatory authorities with jurisdiction over medicinal cannabis. Please refer to answer No. 12.

 

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

There is no regulatory framework. Please refer to answer No. 12.

 

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

It is forbidden to produce and import cannabis intended for medicinal use in the Slovak republic.

Under the Act on Narcotic and Psychotropic Substances it is however permitted to produce and import cannabis intended for industrial or research purposes based on special authorization granted by the Ministry of Health.

It is also permitted (without any special authorization) to import/export seeds of certain cannabis types listed in Common Catalogue of Varieties of Agricultural Plant Species (published in accordance with Council Directive No. 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species).

 

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

No approval or notifications are necessary. Please refer to answer No. 12.

 

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

There is no regulatory framework. Please refer to answers No. 12.

 

18. How can patients obtain Medicinal Cannabis?

Patients cannot legally obtain medicinal cannabis in the Slovak Republic.

 

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis cannot be prescribed in the Slovak Republic.

 

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

No. Please refer to answers No. 1 et seq. to this article.

 

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

No approval or notifications are required.

 

22. Where is Medicinal Cannabis available?

Medicinal cannabis is not legally available in the Slovak Republic.

 

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

No.

 

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

No.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes.

 

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

Regulatory authorities with jurisdiction over opioid drugs are the State Institute for Drug Control and the Ministry of Health.

 

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

No. Authorization, pricing and reimbursement of opioid drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview).

 

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

Act on Narcotic and Psychotropic Substances establishes a list of narcotic and psychotropic substances which are contained as a medicament in the drug (annex No. 1 to the Act on Narcotic and Psychotropic Substances).

Act on Narcotic and Psychotropic Substances also distinguishes so-called excluded preparations which contain narcotic and psychotropic substances listed in annex No. 1 to the Act on Narcotic and Psychotropic Substances in quantity and concentration further stated in annex No. 2 to the Act on Narcotic and Psychotropic Substances. This includes opioid drugs containing certain narcotic and psychotropic substances in such small quantity and concentration that represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse. Such opioid drugs are excluded from scope of the Act on Narcotic and Psychotropic Substances.

Any drug containing narcotics listed in annex No. 1 to the Act on Narcotic and Psychotropic Substances (whether or not they fall under the scope of the Act on Narcotic and Psychotropic Substances) can receive market approval provided that the conditions set out by respective legislation are met. In this regard please refer to answer No. 27 in connection with answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.

 

29. Who can prescribe Opioid Drugs?

Under the Act on Medicinal Products, opioid drugs can be prescribed by a physician. However, if their prescription is linked to a specialization of the physician in respective medical field (specialist), they can be prescribed only by such specialist. The specialist is required to have a specific numeral code assigned by the Health Care Surveillance Authority and an agreement on provision of healthcare with the health insurance company in which respective patient is insured in place.

Opioid drugs can be also prescribed by a general physician (GP) based on recommendation of a specialist listed in patient’s medical record.

Opioid drugs can be prescribed on the specific form of prescription labelled by diagonal blue stripe. These forms must be registered. In addition, the physician is obliged to create so-called “prescription record” signed with the qualified electronic signature into the electronic patient’s medical record.

Opioid drugs containing narcotics and psychotropic substances in only small quantity and concentration which represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse can also be prescribed on general form of description.

 

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

No. Opioid drugs can be prescribed by any doctor who fulfils the conditions outlined in answer No. 29 to this article.

 

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

No approvals or notifications are required. Authorized doctors can prescribe opioid drugs to their patients in their own discretion after thorough assessment of medical state of an individual patient.

 

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

Only organizations authorized to sell opioid drugs to public are the pharmacies which fulfil conditions set out by respective legislation (described in answer No. 8).

Pharmacies can sell these drugs directly to patients upon presentation of an official medical prescription and verification of the identity of the patient.

Wholesale distribution of opioid drugs can be performed by subjects who fulfil conditions set out by respective legislation (described in answer No. 8”). Under the Act on Medicinal Products, these subjects can distribute opioid drugs mostly (but not exclusively) to pharmacies and health care facilities.

Opioid drugs containing narcotics and psychotropic substances in only small quantity and concentration which represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse can also be sold/distributed based on general authorization by the State Institute for Drug Control only (no second – special authorization for handling with opioid drugs containing narcotic and psychotropic substances is necessary).

 

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

No. Any pharmacy/wholesale distributor fulfilling conditions outlined in answer No. 32 to this article (in connection with answer No. 8) is authorized to sell/distribute opioid drugs.

 

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

Yes. Currently, there is a proposal subject to discussions of the Slovak Parliament to amend the Act on Narcotic and Psychotropic Substances. It is being proposed to include further substances to the list of narcotics or the list of psychotropic substances based on the decision adopted on the 63rd Session of the United Nations Commission on Narcotic Drugs, including the synthetic opioid crotonyl fentanyl.

 

35. When are they likely to come into force?

The proposed date of the effectiveness of this amendment is 1 May 2021.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

The legal framework for regulatory reform in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

E-Health

With effect as of 1 January 2018, mandatory e-Health system has been introduced in the Slovak Republic. This reform included the introduction of an electronic health book of a patient, the possibility of prescribing and dispensing the medicinal products and medicinal devices via electronic means, and creation of the national e-health platform – National Health Information Centre. Further functionalities were introduced to e-Health system (such as applications My Health, eAlert or patient summary) and existing functionalities have been improved during the years 2019/2020, while eLab functionality is still being developed (as of February 2021).

 

Clinical Trial Regulation

The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation comes into application. The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a publicly available Clinical Trials Information System (formerly the EU clinical trial portal and database). The European Medicines Agency (EMA) will set up and maintain the information system, in collaboration with the member states and the European Commission.

 

Medical Device Regulations

In 2017, the European Parliament adopted the new EU Regulation on Medical Devices (2017/745) and the EU Regulation on In Vitro Diagnostic Medical Devices (2017/746).

The new Regulations will introduce major changes, such as high-risk medical devices are going to be subject to stricter pre-market control, large part of the information of the EU database on medical devices (EUDAMED) will be made publicly available, requirements for labeling will be increased, requirements for updating of technical documentation will be stricter, a new medical device identification system based on a unique device identifier (UDI) will be introduced, an “implant card” for patients containing information about implanted medical devices will be introduced, the manufacturers will be required to have measures in place to provide sufficient financial coverage in respect of their potential liability.

 

2. When are they likely to come into force?

E-Health – ongoing.

Clinical Trials Regulation – 2021. Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System through an independent audit. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. The entry into application of the Regulation is currently estimated to occur in December 2021. According to the information published by the European Medicines Agency, once the Clinical Trials Information System is launched, it will be immediately available for authorities and clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Clinical Trials Regulation will apply.

Medical Devices Regulations – the EU Medical Devices Regulation (2017/745) will come fully into force on 26 May 2021 (after the laps of the transitional period) and the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) will come fully into force on 26 May 2022 (after the laps of the transitional period).

 

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

An insight into patents & trademarks in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

PATENTS

One can file for patent protection for any invention, in all fields of technology, provided it is new, involves an inventive step, and is capable of industrial application and the fee is paid. Patent protection lasts for 20 years from the date of filing the application and is subject to yearly maintenance fees.

TRADEMARKS

For trademarks, main requirements are the ability of the designation to be capable of (i) distinguishing the goods or services of one undertaking from those of other undertakings; (ii) being represented in the register of trademarks of the Industrial Property Office of the Slovak Republic (the “Industrial Property Office”) in a way that enables the respective authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor; and (iii) the payment of the fee. Trademark protection lasts for 10 years from the date of filing the application and it is possible to renew the validity of the protection on the basis of the application and subject to payment of the fee for further 10 years (repeatedly).

 

2. What agencies or bodies regulate patents and trademarks?

In the Slovak republic, patents and trademarks are regulated by the Industrial Property Office.

 

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

PATENTS

There is no specific list of inventions that can be patented. Any invention that meets the requirements of novelty, inventive step and capability of industrial application can be patented providing this invention is not, in particular:

• discovery, scientific theory and mathematical method;
• aesthetic creation;
• scheme, rules or methods for intellectual acts, games or doing business;
• computer program;
• presentation of information;
• plant variety and animal breed or, basically, any biological means of creation of plants or animals;
• surgical or therapeutic methods of treatment of the human body or animal body, and diagnostic methods and methods for the prevention of diseases exercised on the human body or animal body, except for products, in particular substances or mixtures, usable in any of the above mentioned methods;
• invention relating to the human body at various stages of development or relating only to the appearance of any of the elements of the human body;
• invention which commercial use would be contrary to public policy or good manners (in particular, methods of human cloning, use of human embryo for industrial or commercial purposes).

 

TRADEMARKS

Under Slovak law, any designation, in particular words (including personal names), designs, letters, numerals, colors, the shape of goods or of the packaging of goods, or sounds, provided that such designation is capable of distinguishing itself and can be represented in the register of trademarks of the Industrial Property Office in the manner as outlined in answer No. 1 of this “Chapter 6: Patents and Trademarks” shall be registered.

A designation shall not be registered if it:

• is devoid of any distinctive character;
• consists exclusively of signs or indications which may serve, in business  relationships, to designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or provision of the services, or other characteristics of the goods or services;
• consists exclusively of signs or indications which have become customary in the current language or in established business practices;
• consists exclusively of the shape or another characteristic of the goods, which result from the nature of the goods themselves, which are necessary to obtain a technical result, or which give substantial value to the goods;
• is contrary to public policy or good manners;
• may mislead the public, in particular about the nature, quality or geographical origin of the goods or services;
• has not been authorized by the competent authorities and is to be refused pursuant to Article 6ter of the Paris Convention for the Protection of Industrial Property (the “Paris Convention”);
• its use or registration would be contrary to national law or contrary to obligations of the Slovak Republic or the European Union arising from international treaties, in particular concerning the protection of designations of origin and geographical indications, traditional terms for wine and guaranteed traditional specialties;
• includes badge or emblem of significant symbolic value, especially religious symbols;
• includes badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and which are of public interest, unless the consent of the competent authority to their registration has been given;
• is the subject of an application which has not been manifestly filed in good faith;
• consists of, or reproduces in their essential elements, an earlier plant variety denomination registered in accordance with national law, or international treaties to which the Slovak Republic or the European Union is a party, providing for protection of plant variety rights, and which are in respect of plant varieties of the same or closely related species.

 

4. How can patents and trademarks be revoked?

 

PATENTS

Patent ceases to exist in the following cases:

• its validity has expired;
• owner of the patent does not pay a maintenance fee;
• owner of the patent renounces the ownership of the patent;

Patent will be revoked by the Industrial Property Office (on the basis of the third party’s application or ex offo) if:

• the conditions for its granting have not been met;
• invention is not described in a sufficient and clear manner so that it could be executed by an expert;
• the scope of the patent overreaches the scope of the original application, or if the scope of the patent granted as a result of partition of an application overreaches the scope of the6 original application;
• the scope of patent protection has been extended;
• invention cannot be protected by a patent;
• the owner of the patent holds no right to the invention;
• at the request of the owner.

 

TRADEMARKS

Trademark ceases to exist in the following cases:

• its validity has expired, unless an application for the renewal of the validity of the protection has been filed;
• owner of the trademark renounces the ownership of the trademark.

Trademarks will be revoked by the Industrial Property Office the trademark based on the third party’s application, if:

• trademark was not the subject of factual use in connection with goods or services for a period of minimum five consecutive years;
• as consequence of activity or inactivity of the owner, the trademark has become the common name for goods or services in respect of which it is registered;
• in consequence of the manner of the use of the trademark by the owner or a third party with the consent of the owner in relation to the goods or services for which it is registered, the trademark may mislead the public, in particular on the nature, quality or geographical origin of those goods or services.

Trademarks will be revoked by the Industrial Property Office the trademark based on the concerned party’s application on grounds of a court decision under which:

• trademark containing the name and surname or picture of an individual, or his/her pseudonym, infringes the rights to the protection of the personality;
• trade mark containing the name or business name of an individual or legal person affects its reputation;
• trademark interferes with older copyrights;
• use of this trademark is an unfair competition.

The Industrial Property Office declares the trademark invalid, if the legal requirements for its registration have not been met at the time of its registration. It also declares the trademark invalid in cases in which the Industrial Property Office must refuse the registration of the trademark into the register of trademarks as a result of objections against the registration, e.g. the trademark is identical with the earlier trademark and the affected goods or services are identical with the goods or services for which the earlier trademark is protected, or because of its identity with, or similarity to, the earlier trademark and the identity or similarity of the goods or services covered by the earlier trademark there exists a likelihood of confusion on the part of the public; the likelihood of confusion includes the likelihood of association with the earlier trademark.

 

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

PATENTS

Under the Patent Act, a European patent granted by the EPO under the European Patent Convention has the same force as a Slovak patent, if the applicant included the Slovak Republic as a country in which it seeks patent protection. The patent owner must still submit the translation of the patent documentation into the Slovak language to the Industrial Property Office and pay the publication fee. The Slovak Republic is also a party to the Patent Cooperation Treaty which makes it possible to seek patent protection simultaneously in a large number of countries by filing a single “international” patent application. Nevertheless, the granting of the patent which would be valid for the Slovak Republic remains under the control of the Industrial Property Office in the so-called the “national phase” (the national phase follows the international phase). Nevertheless, the procedures performed during the international phase facilitate the procedures to be carried out by the Industrial Property Office during the national phase.

 

TRADEMARKS

All European Union trademarks registered in the register of European Union trademarks maintained by the EUIPO are also valid in the Slovak Republic. The Slovak Republic is also a party to the Madrid Protocol. Thus, foreign trademarks are recognized via the WIPO’s Madrid system if the applicant includes the Slovak Republic in its application for international registration. If the Industrial Property Office does not notify the WIPO about the refusal of the trademark protection in the Slovak Republic within the statutory deadline, the international registration of the trademark has the same effects as the trademark registered in the register of trademarks of the Industrial Property Office.

 

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

In case of generic medicines that have to be registered with the State Institute for Drug Control, the applicant must prove that the product to be registered is bioequivalent to the reference medicinal product which has been registered in at least one EEA member state for at least eight years. Further, the holder of the marketing authorization for the generic medicine is not allowed to place this product on the market until ten years following the marketing authorisation of the reference medicinal product.

 

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

There are no restrictions explicitly stated in the Slovak legislation on the types of medicines or devices that can be granted patent and trademark protection, except for the general restrictions as provided in Answer No. 3 of this article.

 

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

Patent and trademark license agreements are subject to registration with the Industrial Property Office in order to make them enforceable against third parties.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

All about product liability in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

The Slovak legal order recognizes three types of liability: civil, criminal, and administrative.

Civil liability may be further divided into contractual liability, which results from a failure to comply with contractual obligations (e.g. failure to perform a contract or defective performance of agreed obligation) and non-contractual (delictual) liability, which results from a failure to comply with obligations stipulated by applicable law.

The Slovak criminal law is codified in the Criminal Code, which sets for particular merits of criminal offences. However, the Criminal Code binds only individuals. As of 2016, the concept of direct criminal liability of legal entities has been introduced in the Slovak Republic. This means that certain criminal offences may commit also legal entities. A legal entity shall be liable for criminal offences committed by its statutory body or its member (e.g. managing director), or its controlling or supervising body (e.g. member of the supervisory board), or any other individual authorised to represent the legal entity or adopt decisions on behalf of the legal entity (e.g. proxy) if such criminal offences were committed (i) in favour of the legal entity, (ii) on its behalf, or (iii) via such legal entity or within the scope of its business. Moreover, a legal entity will also be criminally liable in cases when the supervising person (even negligently) enabled other individual, which was acting under the authority given to it by the legal entity, to commit a criminal offence. Legal entity can be criminally liable only for committing criminal offences specifically listed in the Act on Criminal Liability of Legal Entitles.

The Slovak administrative law has not been codified so far in the Slovak Republic. It is scattered in several legal acts which specify the respective administrative offences, the sanctions to be imposed by the respective administrative authority, etc.

 

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

Civil liability:

One of the general principles of the Slovak legal order is that everyone shall be liable for damage caused by failure to comply with legal obligations, i.e., contractual or obligations stipulated by applicable law. Since, generally, no contract exists between the manufacturer and the third parties buying its medicines or devices on the market, if the product causes damage to these third parties, the manufacturer shall be liable for such damage on the grounds of the non-contractual (so-called “delictual”) liability. A general product liability is regulated by the Act on Liability for Damage Caused by Defective Products (based on the EU Product Liability Directive 85/374/EEC) under which a producer is liable for damage caused on health, life of other item, which results from a defective product. In this case, if the damage caused on health or life was caused to more injured parties, the liability of the producer is limited to maximum of approx. EUR 116,000,000.

 

Criminal liability:

The Criminal Code contains several merits related to endangering life or health, in particular endangering health due to unauthorized medicines and devices, unauthorised use and falsification of medicines and devices. However, these criminal offences inflict individuals, not legal entities. There are also certain general criminal offences, e.g. unlawful business activity, harming a consumer, which cover also legal entities in general.

 

Administrative liability:

The Act on Medicinal Products stipulates specific merits of administrative liability of manufacturers of medicines which include, e.g. manufacture of medicine out of scope of granted permit, failure to have or use a system for securing the quality of the production, failure to comply with the requirements of the good manufacturing practices during the production of medicinal products and the control of their quality.

As regards the medical devices, the Slovak Republic is bound by the EU Regulation on medical devices (2017/745). The Act on Conformity Assessment Procedures of Products contains sanctions for breaching certain obligations resulting from the obligatory conformity assessment procedures in relation to products which require such procedures which can be imposed also on the manufacturer of medical devices.

 

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

Civil liability:

In general, a claim arising from the civil liability cannot extend to corporate executives, employees or representatives of the company. Under certain circumstances, the manufacturer as an entity can claim the paid compensation regressively from its corporate executives, employees or representatives. The Commercial Code stipulates the conditions of the liability of its corporate executives towards the company. Basically, the corporate executive shall be liable towards the company for all caused damage, if he/she breaches his/her obligations when acting as a corporate executive of the company, unless he/she proves that he/she was acting with professional care and in good faith that he/she was acting in the interest of the company. The liability of employees towards his/her employer is regulated in the Labour Code. Under the Labour Code, an employee is liable for damage caused when breaching his/her obligations in relation to performing working duties or in direct connection therewith and for damage caused by wilfully acting contrary to good moral conduct. The employer must prove the employee’s fault. An employee’s liability for damages caused as a result of wilful misconduct is unlimited. On the other hand, an employee can be held liable for damages caused as a result of his/her negligence only up to four times his/her average monthly salary.

 

Criminal liability:

The court examines who has committed a criminal offence. Therefore, if the specific individual has fulfilled all the constituent elements of merit of specific criminal offence, the court shall adjudicate that such individual is criminally liable. Under the Slovak legislation, criminal proceedings can run towards the legal entity and an individual for the same criminal offence simultaneously, whereas each is liable independently.

 

Administrative liability:

The Act on Medicinal Products specifies certain administrative offences that may be committed specifically by a professional representative responsible for production of medicinal products or a professional representative responsible for securing of quality of medicinal products. These representatives must be appointed in case of a manufacturer of medicinal products and must be either in employment relationship to the manufacturer, unless the representative is a statutory body of the manufacturer.

 

4. How can a liability claim be brought?

Civil liability claims shall be brought through civil courts.

The law contains a formal procedure for filing criminal complaints. In case of suspicion that a criminal offence has been committed, a criminal complaint may be submitted to any public prosecutor or police officer. However, only courts are entitled to decide on guilt and in this respect impose criminal penalty.

Anybody may file with the administrative body an informal complaint or request for investigation. There is generally, however, no obligation of the respective authorities to initiate proceedings upon such request. On the other hand, certain administrative body are obliged to act “ex offo” if they become aware of infringement of the respective laws.

 

5. What defenses are available?

Generally, the damaged party as the plaintiff has the burden of proof before the civil court that the product is defective, that the damage has occurred and the casual link between the defective product and the resulting damage. Therefore, the defendant may primarily assert that the plaintiff has failed to meet the burden of proof.

Pursuant to the Civil Code if the defendant proves that he/she/it has not caused the damage shall relieve of the liability for such damage. However, the Civil Code sets out also types of claims for damage, when the entity is liable regardless he/she/it have caused the damage or not; the Civil Code in this regard sets out circumstances under which such entity may liberalize itself.

Pursuant to the Act on Liability for Damage Caused by Defective Products a manufacturer of a defective product may liberalize itself if it proves one or more of the following circumstances have occurred:

• the manufacturer has not placed the product into circulation; or
• according to the circumstances that preceded the damage, it is probable that the product was not defective at the time when the product was put into circulation or that such defect has occurred afterwards; or
• the product was neither manufactured by the manufacturer for sale or any form of use for economic purpose nor distributed by the manufacturer within its business activities; or
• the defect has occurred due to compliance of the manufacturer with its obligations resulting from generally binding legal regulations; or
• the state of scientific and technical knowledge at the time when the manufacturer has placed the product into circulation was not such as to enable the detection of the defect.

The manufacturer of a component of a defective product may also liberalize itself provided that the defect is attributable to the construction of the complete product, in which the component has been fitted or to the instructions given by the manufacturer of the complete product or damage was caused as a result of instructions set out in manual of the complete product.

As regards the administrative liability under the Act on Medicinal Products, the manufacturer relieves itself from breaching of its obligations set out in the Act on Medicinal Products (i.e., its acting will not be considered an administrative offence), if it proves before the respective administrative authority that it could not fulfil the given obligations due to exceptional circumstances which it could not change by itself. In addition, according to the Act on Medicinal Products, the holder of the marketing authorization for a medicinal product is obliged to be responsible for damage caused by the registered medicinal product, if it was used in accordance with the data specified in the respective marketing authorization. Also, the issued marketing authorization does not relieve the manufacturer or the holder of the marketing authorization from liability for potential damage which had occurred when using the medicinal product in line with the approved summary of product characteristics and with package leaflet.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

The low-down on the situation regarding traditional medicines and OTC products in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

Traditional herbal medicinal products and homeopathic medicinal products are regulated by the Act on Medicinal Products and its regulations. Traditional herbal medicinal products may receive a marketing authorization following a simplified registration procedure (e.g., it is not required to submit the documentation about results of the clinical trial). The applicant has to submit evidence published in scientific works that the herbal medicinal product has been used for at least 30 years before the submission of the application, including at least 15 years within the EEA member states. This is, however, not required if the traditional herbal medicinal product subject to the application contains herbal preparations or herbal substances listed in the EU list of herbal preparations and herbal substances issued by the European Commission. In case of a traditional herbal medicinal product non listed in the EU list, the State Institute of Drug Control takes into account the marketing approval issued by the competent authority of another EEA member state when assessing the application. If the herbal medicinal product has been used in the EEA member states less than 15 years, but still fulfills the remaining requirements for the simplified registration procedure, the State Institute for Drug Control passes the application to the Committee for Herbal Medicinal Products (HMPC) which has been set up at the European Medicines Agency in order to assess whether the requirements for the simplified registration procedure have been fulfilled.

Homeopathic medicinal products may also receive a marketing authorization following a simplified registration procedure if specific requirements under the Act on Medicinal Products are met, e.g. they are administered orally or externally, they may not contain more than 1 part per 10,000 of the mother tincture or more than 1:100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription. Otherwise, the process of the marketing authorization is the same as in case of (usual) medicinal products.

 

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

Yes, subject to certain restrictions (please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising).

In addition, with respect to traditional herbal medicinal products, in case of any advertising of medicinal products intended for the public the marketed medicinal product must contain also the following text: “Traditional herbal medicinal products for use in indications verified exclusively based upon long-standing use.”

In addition, the Act on Advertising enables the advertising of homeopathic medicinal products which are not registered in the Slovak Republic.

 

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

All medicinal products, including traditional herbal and homeopathic medicines are subject to advertising restrictions regulated by the Act on Advertising. For further information please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

The advertising of medicinal products, regardless of the targeted group (professional or non-expert public), must be consistent with the summary of product characteristics, must promote the rational use of the medicinal product by providing the objective information on the product characteristics, without exaggerating the characteristics of the medicinal product, and at the same time, the advertising shall not be misleading. In addition to the general advertising requirements, any advertising of medicinal products intended for the public shall be drawn so that it is clear that it is an advertising and that the marketed medicinal product can be clearly identified and contain the particulars specified in the Act on Advertising (e.g., the name of the medicinal product, an explicit and understandable appeal to the users to carefully read the user’s written information that is accompanied to the medicinal product). The advertising of medicinal products intended for the public shall not contain several elements specified in the Act on Advertising which, e.g. gives the impression that medical examination or medical treatment is unnecessary, gives the impression that the effects of the medicinal product are guaranteed and are not accompanied by any adverse effects or are better than or equal to the effects of another medicinal product or other treatment, suggests that good health could be improved by using the medicinal product.

The Act on Advertising provides also specific restrictions for advertising of traditional herbal medicinal products, namely the text must contain the following: “Traditional herbal medicinal product for indications certified exclusively for long-term use.”

 

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

Over-the-counter medicinal products are regulated by the Act on Medicinal Products and its regulations. Process of registration, marketing authorization, manufacturing etc. is in general the same as for all medicinal products. For more information please refer to Answers in Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

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

Over-the-counter medicinal products may be sold only in pharmacies. The online sale of over-the-counter medicinal products can only be performed by the holder of the license to operate a public pharmacy.

 

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

Advertising and marketing of over-the-counter medicines are regulated by the same regulations as other medicinal products. For further information please see Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

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

Over-the-counter medicines may be marketed (but only via pharmacies – please refer to Answer No. 5 of Chapter 4: Traditional Medicines and Over-the-Counter Products) and advertised directly to the public. For further information please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

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

The State Institute for Drug Control re-evaluates the classification of a medicinal product in the process of prolonging the registration of the medicinal product or in case when new findings on a registered medicinal product are discovered. If the State Institute for Drug Control discovers new facts about the quality, effectiveness and safety of a medicinal product, it will assess the classification and, if necessary, modify the classification in accordance with the criteria set out in Act on Medicinal Products.

If the State Institute for Drug Control changed the classification of a medicinal product on the basis of pharmacological-toxicological testing or clinical trials, the application of another applicant for a change of the classification of a medicinal product containing the same active substance will not rely on the results of these tests one year after the first change in the classification of the medicinal product.

 

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

Generally, in order to import medicinal products (including the traditional herbal and over-the-counter medicinal product) from the third countries (non-EEA countries), it is necessary to obtain a manufacturing authorization. The imported medicinal products must comply with the GMP requirements. Every batch of imported medicinal products manufactured in third countries must undergo an analysis of all active substances in an EEA member state in line with the registration requirements before it can be released into the EEA market (including the Slovak market). Certain third countries have in place a mutual recognition agreement between the EU and the third country. In such case, special conditions are applicable for such import, e.g. the full analytical testing is not required. If the medicinal product has been released to an EEA member state, it is possible to import it into the Slovak Republic “only” within the authorization for wholesale distribution of the medicinal products.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

MEDICINAL PRODUCTS

In the Slovak Republic, the following authorization procedures are available in order to obtain the market authorization of new drugs:

National procedure:

The national procedure applies, if the new medicinal product has not been authorized in any other EEA state and the applicant for the marketing authorization intends to market the new drug only in the Slovak Republic. The relevant authority for issuance of the authorization is the State Institute for Drug Control. The applicant must submit the European application form via the electronic system “eApplication”. The applicant must also submit the Slovak application form (original) and the completed European application form in paper form. The data in both forms must correspond with each other. Along with the required documentation (e.g., documentation about the results of the clinical trial), the applicant shall submit the samples of the finished medicinal product, the active substances and excipients (in the quantity required for 3 complete analyses).

When reviewing the application, the State Institute for Drug Control examines, among other matters, if the medicinal product, according to the submitted documentation, complies with the requirements of efficiency, safety and quality, if the requirements of the good clinical practice have been met during the clinical trial, if the manufacturer and importer from the countries outside the EEA are able to provide for the production and control, the risk-benefit balance associated with the use of the medicinal product is favourable.

Decentralized procedure:

The decentralized procedure applies, if the new medicinal product has not been authorized in any other EEA member state yet and the applicant for the marketing authorization intends to market the new drug in two or more EEA member states, including the Slovak Republic. The identical application for marketing authorization must be submitted simultaneously to the competent authorities of the concerned member states. In case of the Slovak Republic, the competent authority is the State Institute for Drug Control. The list of the EEA member states, to whom an application for the marketing authorization has been submitted, forms a part of the application. The applicant requests one of the member states concerned to prepare the assessment report about the medicinal product; such member state is then called a reference member state. If the Slovak Republic is the reference member state, the State Institute for Drug Control prepares draft of the assessment report and provides this report to the concerned member states for their comments within 120 days after the receipt of the application. The final assessment report represents then the basis for the local authorizations. If the Slovak Republic is not the reference member state, the applicant does not have to submit the samples of the finished medicinal product, the active substances and excipients to the State Institute for Drug Control.

Mutual recognition procedure:

The mutual recognition procedure is based on the recognition of an existing national marketing authorization (issued in an EEA member state) by one or more other EEA member states. The holder of the authorization informs the reference member state (if the Slovak Republic is not the reference member state) about submitting the application for the mutual recognition to the State Institute for Drug Control. The holder of the authorization also requests the reference member state to prepare the assessment report or to update the report (which was already prepared when granting the authorization) and provide it to the State Institute for Drug Control. If the Slovak Republic is the reference member state, the State Institute for Drug Control prepares the assessment report or updates it within 90 days following the receipt of the application and submits it to the concerned member states for their comments. The final assessment report represents then the basis for the local authorizations. If the Slovak Republic is not the reference member state, the applicant does not have to submit the samples of the finished medicinal product, the active substances and excipients to the State Institute for Drug Control.

Centralized procedure:

Medicinal products can also be authorized with a single application in all EEA countries by the European Commission through the centralized procedure. This authorization is then valid for all EEA member states, including the Slovak Republic, and no separate authorization of the State Institute for Drug Control for the Slovak Republic is then necessary.

With respect to the authorization process for the marketing of traditional herbal medicinal products and homeopathic medicinal products, please refer to Answer No. 1 of Chapter 4: Traditional Medicines and Over-the-Counter Products.

 

BIOLOGICS

The Act on Medicinal Products specifically addresses biologics only in connection with the authorization procedure in case of biologics which are similar to a reference biological medicinal product (so-called biosimilars). If such product does not meet the definition of a generic medicinal product, in particular due to differences between this product and the reference biological medicinal product in starting material used or technological differences in the production process, the results of the relevant toxicological and pharmacological test and the clinical trials related to these differences only must be submitted. It is not necessary to submit the results of toxicological and pharmacological test and the clinical trials already carried out in relation to the reference biological medicinal product to the State Institute for Drug Control. With respect to authorization process for the marketing of generics, please refer to Answer No. 2 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.)

 

MEDICAL DEVICES

In order to place a medical device on the Slovak market, the manufacturer is obliged to register itself (if the manufacture’s place of business or registered seat is in the Slovak Republic) and the medical device with the State Institute for Drug Control (manufacturer’s registration). If the manufacture’s place of business or registered seat is outside the EEA, the manufacturer must appoint a representative, i.e. an individual with residency or place of business in EEA, or a legal person with the registered office in EEA, notify the State Institute for Drug Control about the appointment. If the representative’s residency, place of business or registered office is in the Slovak Republic, it has to carry out the manufacturer’s registration. If the representative’s residency, place of business or registered office is outside the Slovak Republic (however, within the EEA), no registration with the State Institute for Drug Control is required, only its notification as described below (the registration process should be carried out in the EEA member state where the representative has his/her residency, place of business or registered seat).

If the manufacture’s place of business or registered seat is outside the Slovak republic (however, within the EEA), it is sufficient to notify the State Institute for Drug Control in writing about the identification data of the manufacturer and the identification of the medical device (including its labelling and instructions for its use), in case of medical devices of class IIa, IIb and III. In case of medical devices of class I and in vitro diagnostic medical devices, this notification is optional.

For the purpose of the registration or the notification, the applicant submits to the State Institute for Drug Control an application form, along with the required documents (e.g., the manual for the medical device, the respective certificates). In case of the notification, the set of document required is smaller. After the manufacturer’s registration or upon receipt of the manufacturer’s notification, the State Institute for Drug Control will assign the medical device with a code, in both cases within 30 days.

The State Institute for Drug Control continuously maintains, inspects and updates the database of medical devices. If the medical device ceases to comply with the requirements for placing on the market or putting into service, the State Institute for Drug Control decides on the cancellation of the registration or removes the medical device from the medical device database and informs the manufacturer or the representative in writing. The State Institute for Drug Control enters the registration data of the manufacturer, the representative (if any) and the medical device into the European Database on Medical Devices (Eudamed).

In addition, the EU Medical Devices Regulation (2017/745) which is directly applicable in the Slovak Republic should fully apply from 26 May 2021. As a result, the respective provisions of the Act on Medicinal Products will be replaced by the regulation of the EU Medical Devices Regulation. Under the Act on Medicinal Products, the Slovak Office of Standards, Metrology and Testing is the authority responsible for notified bodies under Article 35 of the EU Medical Devices Regulation in the case of the Slovak Republic. With respect to clinical investigations which have started to be conducted prior to 26 May 2021 will continue to be conducted under the Act on Medicinal Products.

With respect to in vitro diagnostic medical devices, the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) should fully apply in the Slovak Republic as of 26 May 2022. Until then, the respective provisions of the Act on Medicinal Products apply.

 

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

A generic version of a medicinal product requires also the marketing authorization issued by the State Institute for Drug Control. In case of generics, the applicant must prove that the product is bioequivalent to the reference medicinal product which has been registered in at least one EEA member state for at least eight years. In such case, the applicant does not have to submit to the State Institute for Drug Control the results of the toxicological, pharmacological and clinical testing carried out by the applicant for the generic version, as the applicant can submit the results of these testing already carried out in relation to the reference medicinal product. In addition, the applicant must provide the State Institute for Drug Control with all information and documents as required in the case of authorization procedure of a new medicinal product, except for the abovementioned.

The holder of the marketing authorization for the generic medicinal product is not allowed to place this product on the market until ten years following the marketing authorisation of the reference medicinal product.

 

3. What are the typical fees for marketing approval?

The fees for marketing approval are published at the webpage of the State Institute for Drug Control (click here).

 

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

The State Institute for Drug Control has 210 days for reviewing the application following its delivery. In the event that the application is not complete and the State Institute for Drug Control requests for its completion, the period shall be interrupted until the date of the submission of the required information, but no longer than by 180 days.

Marketing authorization of a medicinal product is valid for five years. The State Institute for Drug Control may prolong the validity of the authorization on the basis of a written application submitted no later than nine months before the expiry date of the authorization, and on the basis of the review of the risk-benefit balance of the medicinal product.

Based on reasonable grounds relating to the supervision of medicinal products (including the exposition of a nonsufficient amount of patient to the medicinal product), the State Institute for Drug Control may decide to extend the marketing authorization of a medicine for additional five years. Otherwise, it will issue a decision to extend the marketing authorization for an unlimited period of time.

 

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

The registration holder must designate a person responsible for the pharmacovigilance with her/his residency in an EEA member state and a contact person for the pharmacovigilance in the Slovak Republic. The registration holder shall provide the State Institute for Drug Control and the European Medicines Agency with the details of these persons.

The registration holder is obliged, in particular:

• to keep and, upon request, make available to the State Institute for Drug Control the pharmacovigilance system master file;
• to establish, manage and operate a risk management system for each medicinal product;
• to monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions
  of the marketing authorization;
• to ascertain whether new risks have occurred or whether the risks have changed or whether there has been a change in the risk-benefit balance, and to monitor the pharmacovigilance data and on the basis of these findings to update the risk management system;
• to evaluate suspected adverse reactions to the medicinal product and report them to the EudraVigilance database as required by the applicable
  legal regulations.

The physicians, other healthcare providers, persons authorized to dispense medicines and health insurance companies are also required to immediately notify the State Institute for Drug Control of suspected adverse reactions to the medicinal product of which they learned after its registration. On the basis of the assessment of a report of suspected serious adverse reaction of a medicinal product, the State Institute for Drug Control may change, suspend or revoke the marketing registration of a medicinal product.

The registration holder shall also submit electronically a periodic safety update report to the European Medicines Agency, which contains:

• data on the benefit and risks of a medicinal product, including the results of all studies, with regard to their potential impact on the marketing approval of a medicinal product;
• a scientific assessment of the risk-benefit balance of a medicinal product;
• data on the number of packages of the medicinal product sold, the number of medical prescriptions available to the registration holder, including an estimate of the number of persons on which the medicinal product was dispensed.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are basically not valid in the Slovak Republic and authorization of local authorities is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states.

Marketing approval may be also received within the EEA following simplified procedures, i.e., the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). Still, a separate authorization issued by the State Institute for Drug Control is required.

 

7. Are parallel imports of medicines or devices allowed?

The Act on Medicinal Products regulates condition of the parallel imports of medicinal products. Parallel import of medicinal products may only be granted to the holder of the authorization for the wholesale distribution of medicinal products. Parallel import authorization may be granted only if a parallel imported medicinal product is registered in another EEA member state under the same conditions as a medicinal product registered in the Slovak Republic. The parallel imported medicinal product must not differ in quality, effectiveness and safety from the reference medicinal product. The medicinal product shall be distributed from the given EEA member state to the Slovak Republic:

• under the same name;
• with qualitatively and quantitatively identical active substances;
• with identical dosage form and appearance;
• with identical packaging sizes;
• with identical inner and outer packaging and with the same graphic design
  of both packaging;
• by the same manufacturer, excluding the manufacturer of the inner and outer packaging and of the written information for the user of the medicinal product.
• An application for a parallel import authorization shall be filed with the State Institute for Drug Control, which will decide on it within the period of 45 days. The authorization for parallel import of a medicinal product is valid for one year from the date on which the authorization decision became effective; this authorization may be extended for another year, even repeatedly, by the application filed at least three months before the expiry date of the authorization.

With respect to the medical devices, the manufacturer’s registration with or the notification of the State Institute for Drug Control are required. For more details please refer to Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

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 restrictions on marketing practices can be found in the Act on Medicinal Products and the Act on Advertising. The Act on Medicinal Products prohibits to certain subjects (e.g., holders of authorization for manufacturing of medicinal products, holders of marketing approval, and the pharmacies) directly or through a third person, to induce, encourage, or otherwise influence the doctor entitled to prescribe medicinal products with respect to their prescription. Further, it is also prohibited (with respect to certain subjects, including the holders of authorization for manufacturing of medicinal products, holders of marketing approval, the pharmaceutical companies), directly or through a third person, to finance, sponsor, or otherwise directly or indirectly financially or materially support other than professional events or participation of healthcare professionals on other than professional events. The amount of the expenditures for marketing and promotion related monetary or non-monetary benefits provided to healthcare professionals (including the information about the respective healthcare professionals) are subject to reporting duties towards the National Centre of Healthcare Information under the conditions specified in the Act on Medicinal Products. According to the Act on Advertising, it is not allowed to visit persons authorized to prescribe medicinal products during their office hours in order to promote medicinal products and these persons are not allowed accept such visits.

The Act on Advertising regulates also prohibition of certain activities, such as supplying, offering and promising gifts, monetary and material benefits or profits to persons authorized to prescribe or dispense medicinal products. The persons authorized to prescribe or dispense medicinal products are also not allowed to require or accept such gifts, monetary and material benefits or profits. The marketing authorization holder may, upon written request, provide a sample of medicinal products only to a person authorized to prescribe medicinal products. The quantity of samples provided is limited to two pieces of the smallest package of the registered medicinal product per year. This sample must be labeled “FREE MEDICAL SAMPLE – NOT FOR SALE” and must be accompanied by the summary of product characteristics. Medicinal product that contains narcotic and psychotropic substances may not be provided as samples.

The Act on Advertising regulates also the sponsorship of promotional events and scientific congresses attended by the persons authorized to prescribe or dispense medicinal products which is also considered as a form of advertising. The hospitality being offered, directly or indirectly, at these events must always be strictly limited to the main scientific objective of the event and it must not be extended to persons other than healthcare professionals. According to the Act on Medicinal Products, a professional event is an event aimed exclusively on professional, scientific or educational purpose of healthcare professionals. Entertainment may form part of such events in the reasonable extent, whereas the entertainment cannot timely exceed 20% of the entire event (excluding time for travel and overnight accommodation).

The pharmaceutical companies in the Slovak Republic usually also adhere to the Ethical Code of the Pharmaceutical Industry in Slovakia which regulates the marketing practices of medicinal products in more detail, or the respective Codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA), e.g. EFPIA HCP Code.

 

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

The requirements for manufacturing of medicinal products are primarily set out in the Act on Medicinal Products, in Decree of the Ministry of Health on the Requirements on the Good Manufacturing Practice, and in EU Good Manufacturing Practice (GMP) guidelines – Volume 4.

According to the Slovak legislation, the manufacturing of medical devices does not require any special authorization. Although, the manufacturer’s registration with or the notification of the State Institute for Drug Control are required before the manufacturer places the medical device on the Slovak market. For more details please refer to Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising. As regards the manufacturing of medical devices, the Slovak Republic is bound by the EU Regulation on medical devices (2017/745). The manufacturer of medical devices must also observe the Act on Conformity Assessment Procedures of Products and related legal regulations.

The supervision authority in connection with manufacturing of medicinal products and medical devices is the State Institute for Drug Control.

 

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?

According to the Act on Medicinal Products the manufacturing requirements of medicinal products must comply with EU GMPs.

EU and US have entered into a mutual recognition agreement on GMP inspections. As of 11 July 2019, the Slovak Republic has become the final EU member to be given the powers to carry out good GMP inspections at a level equivalent to that prevailing in the US.

 

11. What is the inspection regime for manufacturing facilities?

Inspections of manufacturing facilities are carried out by the State Institute for Drug Control to ensure compliance with the obligations under the Act on Medicinal Products and the requirements of GMPs. The State Institute for Drug Control may carry out initial inspections, unannounced inspections or repeated inspections on its own initiative, at the request of another EEA member state, the European Commission or the European Medicines Agency, or on the initiative of other entities as specified in the Act on Medicinal Products (e.g. the holder of the manufacturing authorization, the holder of the authorization for wholesale distribution of the medicinal products).

Inspection is carried out by the inspectors of the State Institute for Drug Control who are authorized to, in particular:

• enter the facilities in which the medicinal products are handled, in case of suspicion that these are handled there without the necessary authorization;
• collect samples in the necessary amount and extent (without any consideration) for performing of an independent analysis;
• examine all records and documents, request for information and explanation relating to the subject matter of the inspection.

The failure to comply with the requirements of GMPs during manufacturing of medicinal products is deemed an administrative offence according to the Act on Medicinal Products and can be subject to a fine imposed by the State Institute for Drug Control.

 

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

In the Slovak Republic, the State Institute for Drug Control and its inspectors primarily responsible for inspecting manufacturing sites located in the Slovak Republic. Under the Act on Medicinal Products, in case of a repeated inspection, the inspector performing the initial inspection may be joined by two inspectors from the competent authority of other EEA member states which are not concerned parties in the respective dispute (in case that the competent authority of other EEA member state disagrees with the report on the results of the inspection performed by the State Institute for Drug Control).

 

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

MEDICINAL PRODUCTS

Specific requirements for storage, packaging and handling of medicinal products are regulated by the Decree of the Ministry of Health on Good Manufacturing Practice (GMP) Requirements and the Good Distribution Practice (GDP) Requirements, and also in the Decree of the Ministry of Health on Good Pharmacy Practice (GPP) Requirements.

As regards the premises for the wholesale distribution, the storage areas for medicinal products, active substances, excipients and packaging shall have an area of at least 150 m2 and medicinal products containing narcotic and psychotropic substances shall not be stored here, these shall be stored separately. A separate area shall be for receipt, unpacking and sorting of deliveries, and a separate area shall be for the preparation of deliveries to the pharmacies and their shipment. The Decree on the GMP and GDP Requirements specifies also the minimal material and technical equipment for the storage of medicines, active substances, excipients and packaging (e.g., calibrated thermometers and hygrometers in all premises intended for storage, refrigerators or refrigerator boxes with calibrated storage thermometers). These areas shall be kept clean.

Medicinal products, active substances, excipients and packaging are kept separate. No other goods may be stored in the same storage area. Medicinal products must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. Temperature and humidity shall be regularly recorded, controlled and evaluated. If storage conditions require special conditions for the temperature and humidity of the storage department, the storage departments shall be equipped with devices indicating the failure to keep the required temperature and humidity. Medicinal products with expired expiration dates must be separated from other medicines and stored in a separate compartment; such medicinal products must be disposed of in accordance with the special legislation. Medicinal products with damaged closure or packaging and contaminated medicinal products shall be withdrawn from the storage. If they are not destroyed immediately, they must be stored in a separate area to avoid further handling.

Medicinal products, active substances, excipients and packaging are kept separate. No other goods may be stored in the same storage area. Medicinal products must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. Temperature and humidity shall be regularly recorded, controlled and evaluated. If storage conditions require special conditions for the temperature and humidity of the storage department, the storage departments shall be equipped with devices indicating the failure to keep the required temperature and humidity. Medicinal products with expired expiration dates must be separated from other medicines and stored in a separate compartment; such medicinal products must be disposed of in accordance with the special legislation. Medicinal products with damaged closure or packaging and contaminated medicinal products shall be withdrawn from the storage. If they are not destroyed immediately, they must be stored in a separate area to avoid further handling.

Medicinal products, active substances, excipients and packaging shall be transported in a way to prevent the damage of the document with delivery information, their destruction, spillage or loss, the exposition to excessive heat, cold, light, moisture, microorganisms and parasites. If the transport of medicinal products requires the controlled temperature conditions, the transport shall be carried out only by motor vehicles that meet these conditions. Additional requirements apply to motor vehicles in which medicinal products containing narcotic and psychotropic substances can be transported (e.g., windows with grates, built-in safe).

 

MEDICAL DEVICES

The requirements for storage, packaging and handling of medical devices are less strict than those of medicinal products. They are primarily regulated in the Decree on GPP Requirements. Medical devices shall be stored separately from the medicinal products, active substances, excipients, dietetic food and additional assortment of the pharmacy. They must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. It is necessary to monitor, record and evaluate the temperature and humidity in the storage areas on the daily basis.

Medical devices with expired dates of usable life or medical devices with damaged or dirty packaging must be stored separated and labelled “discarded”.

 

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

MEDICINAL PRODUCTS

The following must appear on the outer and immediate packaging of a medicinal product (in the Slovak language):

• the product name, the strength, the pharmaceutical form, and, if necessary, an indication as to whether it is a medicine intended for babies, children or adults; if the medicinal product contains no more than three active substances, an international non-proprietary name shall be provided and if such name does not exist, the common name;
• the list of active substances using international non-proprietary names of active substances, their quantity per dosage unit, depending on the form of administration, in weight units or volume units;
• the pharmaceutical form and the contents of the packaging in weight units, volume units or pieces;
• list of those excipients whose specification on the outer packaging is necessary for the proper use of a the medicinal product; if the medicinal product is injectable or intended for use on the skin or eye, all excipients must be state;
• the method and the route of administration way of use of the medicine;
• a special warning that the medicinal product must be stored out of reach of children;
• specific warnings, if this is necessary for the medicinal product;
• unencrypted expiry date (month and year);
• special storage precautions, if any;
• the method of disposal of unused medicinal products or waste materials from the medicinal products, and a reference to the method of collection of unused medicinal products;
• the name and surname, the address of residence of the registration holder, in the case of a natural person; or, the name or business name, registered seat and legal form of the registration holder, in the case of a legal entity;
• the number of the registration authorization;
• the batch number;
• classification of the medicinal product into the group of prescription-only medicinal products or into the group of non-prescription medicinal products;
• purpose and instructions on the use of a non-prescription medicinal product;
• the GTIN number, if the medicinal product is labeled with it;
• safety feature that enables the authentication of the medicinal product, identification of its packaging and the detection of unauthorized handling with the medicinal product.

The Act on Medicinal Products specifies the minimal particulars which must appear on immediate packaging which take the form of blister packs or on which the particulars above cannot be displayed.

As regards the package leaflet, it must be prepared in line with the summary of product characteristics and must be in the Slovak language. The Act on Medicinal Products lists the respective particulars which must appear on the package leaflet in the order as specified in the Act on Medicinal Products.

 

MEDICAL DEVICES

Each medical device must be accompanied by the information necessary for the safe and proper use of the medical device and for identification of the manufacturer, taking into account the education and knowledge of potential users. Each package of medical device shall be accompanied by instructions for use. Medical devices of class I and class IIa, the use of which is safe even without instructions do not need to contain instructions for use provided their use is secured also without the instruction for use.

The labelling of the medical device must include, inter alia, the following information:

• the manufacturer’s identification data;
• the information necessary for the user for the identification of the medical device and the contents of the packaging;
• the batch number or its code;
• the year and month until the medical device can be used safely (if necessary);
• indication that the medical device is intended for disposable use (if necessary);
• special storage and / or handling conditions;
• special instructions for use and warnings.

 

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

The outer packaging of the medicinal products may also include pictorial markings, price of the medicinal product, details on the conditions of reimbursement of the medicinal product based on public health insurance, and details of the authenticity and identification of the medicinal product. The package leaflet may include sings or pictorial characters in order to explain certain information.

 

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

Labeling and packaging must not contain any additional information not anticipated by the Act on Medicinal Products, or not approved during the registration process before the State Institute for Drug Control. Please also refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

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

According to the Act on Advertising, advertising of medicinal products must meet the general requirements for advertising, e.g., it must be in accordance with competition rules and good morals, must not be hidden and must not have signs of unfair commercial practices. The advertisement may not present food and nutritional supplements as if they had the effects of a medicinal product. The Act on Advertising sets out in which cases a comparative advertisement is allowed.

The advertising of medicinal products, regardless of the targeted group (professional or non-expert public), must be consistent with the summary of product characteristics, must promote the rational use of the medicinal product by providing the objective information on the product characteristics, without exaggerating the characteristics of the medicinal product, and at the same time, the advertising shall not be misleading.

The Act on Advertising prohibits advertising of medicinal products:

• which are not registered in Slovak Republic;
• which contain narcotics, psychotropic substances and preparations;
• whose expenditure is subject to medical prescription;
• whose expenditure is not subject to medical prescription but are reimbursed on the basis of public health insurance.

The above mentioned prohibition does not apply to vaccination campaigns authorized by the Ministry of Health and to advertising intended for persons authorized to prescribe and dispense medicinal products. Further, the Act on Broadcasting and Retransmission prohibits media commercial communication regarding medicinal products subject to medical prescription or medicinal products which are reimbursed from the public health insurance, and prohibits advertising of medicinal products containing narcotic, psychotropic, and other addictive substances.

In addition to the general advertising requirements, any advertising of medicinal products intended for the public shall be drawn so that it is clear that it is an advertising and that the marketed medicinal product can be clearly identified and contain the particulars specified in the Act on Advertising (e.g., the name of the medicinal product, an explicit and understandable appeal to the users to carefully read the user’s written information that is accompanied to the medicinal product). The advertising of medicinal products intended for the public shall not contain several elements specified in the Act on Advertising which, e.g. gives the impression that medical examination or medical treatment is unnecessary, gives the impression that the effects of the medicinal product are guaranteed and are not accompanied by any adverse effects or are better than or equal to the effects of another medicinal product or other treatment, suggests that good health could be improved by using the medicinal product.

The Act on Advertising provides also certain specific advertising requirements towards the professional public in case of which the prohibition on advertising of prescription-only medicinal products does not apply. Advertising of medicinal products to the professional public must include:

• basic information on the medicinal product that complies with the summary of product characteristics;
• classification of the medicine according to the method of dispensation; • date of preparation or date of update;
• the documentation (part of the medicine promotion) must contain pre-cise and up-to-date information that is verifiable and sufficiently complete to enable the recipient to make his/her own opinion on the therapeutic value of the medicinal product;
• price offers, tables and other illustrations (taken from medical journals or other scientific works) that are used in the documentation must be reproduced faithfully and the exact source must be given.

As regards the medical devices, their advertising is not so strictly regulated in comparison with the advertising of medicinal products. Basically, the advertising of medical devices must comply with the general requirements for advertising.

With respect to restrictions on marketing practices, please also refer to Answer No. 29 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

Additionally, as regards medical devices, the EU Medical Devices Regulation (2017/745) expressly prohibits to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the medical device’s intended purpose, safety and performance by:

• ascribing functions and properties to the device which the medical device does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the medical device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the medical device in line with its intended purpose;
• suggesting uses for the medical device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

 

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

Medicinal products can only be dispensed in pharmacies. Medical devices can be dispensed in pharmacies and in the respective trading places for medical devices, or in optical shops (optical medical devices). Non-prescription medicinal products and medical devices (subject to limitations) can be sold also online (and delivered via post). The online sale of medicinal products can only be performed by the holder of the license to operate a public pharmacy (with respect to medicinal products or medical devices) or holder of the license to operate a trading place for medicinal devices (with respect to medical devices).

 

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

There are no specific restrictions and requirements for electronic marketing of medicinal products and the advertising of medicinal products must comply with requirements described in Answer No. 17. of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising. Additionally, according to Act on Electronic Communications and the Act on Advertising, it is prohibited to send commercial notices via electronic means without prior customer’s consent (subject to exemptions provided in the Act on Electronic Communications).

According to the Ethical Code of the Pharmaceutical Industry in Slovakia (although the code is not obligatory, the pharmaceutical companies in the Slovak Republic usually adhere to its provisions), any information provided to the healthcare (professional) community on the internet websites, that is part of the marketing, must comply with applicable legislation and any other regulations governing the content and form of advertising and marketing of medicinal products. Such information shall be clearly marked as “information to the healthcare professionals”, whereas the information need not to be encrypted or otherwise restricted only to the healthcare professionals.

 

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

Prescription-only and reimbursable medicinal products cannot be advertised to consumers. Prescription-only medicinal products can be sold directly to the consumer subject to the presentation of the respective prescription. For further information please refer to Answers No. 17 and 18 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

21. How is compliance monitored?

Compliance with legal requirements of the Act on Advertising is monitored primarily by the State Institute for Drug Control with respect to the medicinal products and the Slovak Trade Inspection with respect to medical devices.

 

22. What are the potential penalties for noncompliance?

If the State Institute for Drug Control detects a violation of the Act on Advertising, it will prohibit circulation of such advertisement. In addition, the State Institute for Drug Control may impose a fine to the advertiser and to the marketing authorization holder of up to EUR 66,400 and to the sponsor of the advertisement a fine of up to EUR 166,000.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Preclinical and clinical trial requirements in Slovakian Pharma – a legal guide. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

No, clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the marketing approval must submit a declaration that the clinical trial performed outside the EEA meets the ethical requirements as required by the Act on Medicinal Products.

 

2. How are clinical trials funded?

In the Slovak Republic, clinical trials are generally funded by sponsors from the pharmaceutical industry. According to the Act on Medicinal Products, the sponsor is an individual or a legal person who manages and finances the clinical trials. The sponsor can be represented in the matters connected with the clinical trial on the basis of a power of attorney by an individual or a legal person (the Representative, usually a contract research organization); nevertheless, the sponsor remains responsible for the performance of the clinical trial in line with the Act on Medicinal Products. The sponsor or its Representative must have a residency (in case of an individual) or its registered seat (in case of a legal person) in an EU member state.

The financing arrangements of the clinical trial are generally regulated in a separate agreement between the sponsor and the investigator.

 

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

According to the Act on Medicinal Products, a clinical trial shall be conducted according to a trial protocol which contains the following:

• objectives and design of the clinical trial;
• criteria for inclusion of the participants in the clinical trial and their exclusion from the clinical trial;
• methodology of monitoring and managing the clinical trial;
• requirements for storage and handling of the investigational medicinal product;
• methodology of the statistical evaluation and manner of publishing the generated results;
• the approved protocol modifications; and
• the data about the investigator.

The trail protocol must be prepared in line with the requirements of the Guideline for good clinical practice (ICH) and the trail protocol itself must contain a declaration that the clinical trial will be conducted in line with this guideline.

The trail protocol (among other documents) must be submitted to and approved by the respective Ethics Committee and the State Institute for Drug Control. In order to obtain an approval of the State Institute for Drug Control, the respective Ethics Committee must issue a positive opinion to the clinical trial.

 

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

The participants in a clinical trial should be firstly thoroughly advised on the scope, nature, consequences and risks of the clinical trial. The advice must be given clearly and in suitable language and the participants must be given sufficient time in order to freely decide to give their consent. The informed consent must be in writing, dated and signed by the participant capable of giving his/her consent. If the participant is not capable of giving his/her consent, the informed consent must be signed by the legally designed representative of the participant. If the participant is capable of giving his/her consent, however, he/she is incapable of writing, he/she can give his/her consent orally into a deed in the presence of at least one witness who will sign this deed.

The information for the participants must contain, among other matters, the following:

• information on the clinical trial and its objectives;
• possible benefit of the clinical trial to the participant;
• possible risks and disadvantages of the clinical trial to the participant;
• advice on other treatment possibilities;
• provision for confidentiality of personal data;
• information on the rights of the participant;
• information on possibility of the participant to withdraw from the clinical  trial at any moment and on manner and consequences of possible interruption of the clinical trial;
• information on compensation of the participant;
• measures for providing for an adequate compensation in case of damage  to the health of the participant in connection with his/her participation in  the clinical trial;
• sources of financing of the clinical trial;
• opinion of the Ethics Committee.

Additional requirements apply on minors, and adults who are incapable of exercising legal acts.

 

5. May participants in clinical trials be compensated?

In Slovakia, the participants in the clinical trials may be compensated. The information on their compensation (including the amount, the manner, and the payment schedule) or reimbursement of expenses should be included in the informed consent to be signed by each participant in the clinical trial. This information should be, however, formulated in a non-motivating manner. The compensation should be paid out in portions, and not as a lump sum paid out at the end of the clinical trial. In addition, the sponsor is obliged to pay all expenses connected with the clinical trial, including all expenses for the examinations and therapies as specified in the protocol.

When reviewing the application for the opinion to the clinical trial, the respective Ethics Committee observes also the arrangement on the compensation or reimbursement of expenses to be provided to the participants. It also reviews whether it does not represent a pressure on the participants or their unreasonable influencing.

 

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

The statutory condition for conducting a clinical trial is the existence of the insurance policy covering the civil liability insurance for damage caused to the participant concluded by the healthcare provider. According to the Act on Medicinal Products, the sponsor bears all expenses connected with the conclusion of this insurance policy. Also, when reviewing the application for the opinion to the clinical trial, the respective Ethics Committee observes also the insurance policy covering the liability insurance for damage concluded by the sponsor, if the health of the participant is damaged or if the participant dies in connection with the clinical trial. Generally, the insurance does not cover claims of the investigator caused as a result of its unprofessional treatment or negligence, or claims of the investigator or the participant caused as a result of their acting at variance with the protocol.

In addition, the sponsor is obliged to reimburse all expenses related to the treatment of health complications and possible permanent consequences on the health of the participant caused as a result of the clinical trial.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

 

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

In the Slovak Republic, the main regulatory authorities over medicinal products, biologicals, and medical devices are the State Institute for Drug Control and the Ministry of Health.

 

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

In the Slovak Republic, the main regulatory framework for the authorization of medicinal products, biologicals, and medical devices is the Act on Medicinal Products and related regulations (including respective EU regulations which are directly applicable in the Slovak Republic). As regards the pricing and reimbursement of medicinal products, biologicals, and medical devices, the main regulatory framework is the Act on Reimbursement of Medicinal Products and Medical Devices from the Public Health Insurance System and related regulations.

 

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

In the Slovak Republic, the handling with medicinal products and medical devices, in particular the production of medicinal products, wholesale distribution of medicinal products and provision of pharmacy services, requires a special license for the respective activity issued under the Act on Medicinal Products.

The authorization for manufacturing of medicinal products is required for manufacturing of medicinal products. The State Institute for Drug Control recognizes the authorization for manufacturing of medicinal products issued by the respective authority of another EEA member state. The authorization for manufacturing of medicinal products is required also for import of medicinal products from non-EEA countries. If the applicant fulfils the respective obligations specified by the Act on Medicinal Products, the State Institute for Drug Control issues the authorization for manufacturing of medicinal products within 90 days following the delivery of the application.

The clinical trials require the approval of the the State Institute for Drug Control. In order to obtain the approval of the State Institute for Drug Control, the respective Ethics Committee must issue a positive opinion to the clinical trial. The State Institute for Drug Control then decides on the application within 60 days (subject to certain exemptions provided in the Act on Medicinal Products) following its delivery.

In order to place the medicinal product on the Slovak market, the marketing authorization of the State Institute for Drug Control is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states. The State Institute for Drug Control has 210 days for reviewing the application following its delivery. Marketing authorization may be also received within the EEA following simplified procedures, i.e., the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). Still, a separate authorization issued by the State Institute for Drug Control is required.

Please see Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising for the details about the process for obtaining the marketing authorization of new medicinal products and other medicinal products in the Slovak Republic and the requirements for placing medical devices into the Slovak market.

 

4. What are the approximate fees for each authorization?

The administrative fee for the authorization for manufacturing of medicinal products amounts to EUR 100 if the manufacturer is an individual and EUR 250 if the manufacturer is a legal entity.

The administrative fee for the registration of the manufacturer of a medical device amounts to EUR 720 (according to the Scale of Fees issued by the State Institute for Drug Control effective as of 1 January 2021).

The administrative fee for the decision on the approval of the clinical trial amounts to EUR 331.50 with respect to medicinal products and EUR 165.50 with respect to medical devices (to be increased to EUR 300 for clinical trials of medical devices under the EU Medical Devices Regulation (2017/745)).

The administrative fees for marketing approval are published at the webpage of the State Institute for Drug Control (click here).

The price list of the services provided by the State Institute for Drug Control sets prices for additional activities performed by the State Institute for Drug Control, e.g., issuance of a certificate on compliance with the requirements of the GMP.

 

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

Marketing authorization of a medicinal product is valid for five years. The State Institute for Drug Control may prolong the validity of the authorization on the basis of a written application submitted no later than nine months before the expiry date of the authorization, and on the basis of the review of the risk-benefit balance of the medicinal product.

Based on reasonable grounds relating to the supervision of medicinal products (including the exposition of a non-sufficient amount of patient to the medicinal product), the State Institute for Drug Control may decide to extend the marketing authorization of a medicine for additional five years. Otherwise, it will issue a decision to extend the marketing authorization for an unlimited period of time.

 

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

A generic version of a medicinal product requires also the marketing authorization issued by the State Institute for Drug Control. In case of generics, the applicant must prove to the State Institute for Drug Control that the product is bioequivalent to the reference medicinal product which has been registered in at least one EEA member state for at least eight years. In addition, the applicant must provide the State Institute for Drug Control with all information and documents as required in the case of authorization procedure of a new medicinal product, except for the following. The applicant does not have to submit to the State Institute for Drug Control the results of the toxicological, pharmacological and clinical testing carried out by the applicant for the generic version, as the applicant can submit the results of these testing already carried out in relation to the reference medicinal product.

In the Slovak Republic, there is basically no difference between local manufacturers and foreign-owned manufacturers. However, the applicants for the marketing authorization must have their residency or registered seat in the Slovak Republic or in another EEA member state. In case of medical devices, the procedure differs if the manufacture’s place of business or registered seat is outside the Slovak Republic (please see Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising for more details).

 

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

There is no specific regulation on the combination products. Basically, combination products drug + drug and drug + biologic fall under the regulatory framework of medicinal products and the Act on Medicinal Products should be applicable.

With respect to the combination products drug + device, biologic + device and drug + biologic + device, if the medical device and the medicinal products (the active substance) form an integral product, the medical device is intended only for use in such combination, is not reusable, and fulfils the technical requirements of the safety and effectiveness as specified by specific legal regulations, it shall be tested and approved as a medicinal product. Further, when deciding whether a product is a medicinal product or a medical device, the main effect shall be considered. Also, when deciding whether a product is a medicinal product or a medical device, the main effect shall be considered with respect to the medicinal product, and the main mechanism of the effect by which the purpose of determining specified by the manufacturer is achieved shall be considered with respect to the medical device. In addition, the EU Medical Devices Regulation (2017/745) which regulates also these matters should fully apply in the Slovak Republic from 26 May 2021.

 

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

The State Institute for Drug Control performs state supervision over the compliance with the Act on the Medicinal Products and fulfilment of obligations imposed on the basis of its decisions and measurements with respect to specified subjects, including the manufacturer of medicinal products and medical devices, the wholesale distributors. In addition, it carries out inspections in order to ensure compliance with the requirements of GMP, GDP and good clinical practice in the area of human pharmacy.

The State Institute for Drug Control also operates and manages the pharmacovigilance system which is regularly audited by the State Institute for Drug Control. The pharmacovigilance system is also obligatory for the holders of marketing authorization which must also evaluate suspected adverse reactions to the medicinal product and report them to the EudraVigilance database. The physicians, other healthcare providers, persons authorized to dispense medicines and health insurance companies are also required to immediately notify the State Institute for Drug Control of suspected adverse reactions to the medicinal product of which they learned after its registration. On the basis of the results of the information from the pharmacovigilance system, the State Institute for Drug Control may change, suspend or revoke the marketing registration of a medicinal product. The State Institute for Drug Control also participates in the pharmacovigilance process in the EU.

With respect to the medical devices, the State Institute for Drug Control performs supervision over the medical devices and records and evaluates information about reported accidents, defects and malfunction of medical devices. In addition, the EU Medical Devices Regulation (2017/745) which is directly applicable in the Slovak Republic should fully apply from 26 May 2021. As a result, the respective provisions of the Act on Medicinal Products regulating the supervision over the medical devices and related matters will be replaced by the regulation of the EU Medical Devices Regulation. Still, the State Institute for Drug Control will perform the responsibilities of the Slovak Republic as the member state under the EU Medical Devices Regulation.

In general, the Slovak regulatory regime can be deemed comparable with the EU law. The State Institute for Drug Control frequently refers to European Medicines Agency’s Guidelines and other related documents. EU and US have entered into a mutual recognition agreement on GMP inspections. As of 11 July 2019, Slovakia has become the final EU member to be given the powers to carry out good GMP inspections at a level equivalent to that prevailing in the US.

 

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

In general, the State Institute for Drug Control can impose a fine ranging from EUR 300 to EUR 35,000 or Ministry of Health can impose a fine ranging from EUR 500 to 1,000,000 for non-compliance with the Act on Medicinal Products (depending on the breach). In case of a repeated breach, the fines can be doubled (or in certain cases even tripled).

The respective authority which issued the respective authorization may also suspend the activity to the respective authorization holder and order to remove the ascertained failure, revoke the respective authorization, to suspend or to revoke the registration of the medicinal product. With respect to the medical devices, the State Institute for Drug Control can prohibit the clinical testing of the medical device, its placement on the market or operation, its removal from the market or operation.

 

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

Yes, there is a national healthcare system in Slovakia. The healthcare system in Slovakia is based on the principle of universal accessibility of health care and solidarity, mandatory health insurance, free choice of the respective health insurance company and a basic package of healthcare covered by the public health insurance.

In general, all Slovak residents (subject to exceptions specified by the Act on Health Insurance) must mandatorily participate in the public health insurance system. The Slovak legislation specifies the respective types of healthcare covered by the public health insurance system and the extent of the coverage; basically, the public health insurance system fully covers preventive medical examinations, diagnosis of a disease, and treatment of priority diseases as specified by the Slovak legislation; it also regulates the medicinal products which are fully and partially covered by the public health insurance and the respective conditions thereof.

The Ministry of Health is responsible for the general management of the healthcare system and health insurance system, the price regulation and preparation of the state health policy objectives. Certain responsibilities of the Ministry of Health have been delegated to the regional level (e.g. issuance of authorizations of certain health care providers). The supervision of the healthcare system is under the scope of the Health Care Surveillance Authority (established by the Act on Health Insurance Companies) whose executive bodies are appointed by the Slovak government based on the proposal of the Minister of Health.

The Health Care Surveillance Authority is the competent authority for the issuance of the authorization for performance of public health insurance to the health insurance company. The health insurance companies are obliged to provide for the healthcare for their clients. They have a key role in the system of the purchase of healthcare services by contracting the respective healthcare providers. The compulsory contributions to the public health insurance system are collected by the health insurance companies and are redistributed according to the system of risk adjustment (the system takes into consideration the groups of the insured persons according to their age, gender, economic activity and pharmacy-based costs).

The Slovak public health insurance system is based on compulsory monthly contributions (largely employment-based contributions) of the subjects to the health insurance system (including the state which pays the insurance payments for socially least favoured individuals, like children, students, pensioners, etc.) to their respective health insurance company (currently only 3 insurance companies have the respective authorization to perform the public health insurance in Slovakia, 1 insurance company is owned by the state). The insurance payments paid by the state are paid by the Ministry of Health from the state budget. The public health insurance system is partially financed also from the budgets of the respective regions and municipalities, and from out-of-pocket payments of patients, e.g. surcharges for the prescribed medicinal products. In comparison with the public health insurance, private health insurance is rather negligible in the Slovak Republic.

 

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

In the Slovak Republic, the public healthcare providers provide mostly the inpatient healthcare services. They are usually profit-making or non-profit-making entities, founded by the Ministry of Health or the respective regional entity or municipality. The public healthcare system constantly faces the lack of finances, material/equipment and personnel. The state determines the minimal network of public healthcare providers with which all health insurance companies have to conclude the agreements in order to preserve the principle of universal accessibility of the public healthcare system.

The outpatient clinics are usually in private hands. There are also few private healthcare providers which provide inpatient healthcare services. The health insurance companies have in place the agreements also with certain private healthcare providers, so certain services provided to the patients by these providers can be fully or partially covered by the public health insurance system.

 

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

The prices of medicinal products and medical devices are regulated as further described. The competent authority for the price regulation is the Ministry of Health. In general, medicinal products with officially determined price and registered in the “List of medicinal products with officially determined price” are fully reimbursable from the public health insurance system only when administered within hospital care (uninterrupted health care for more than 24 hours). In order to become (partially or fully) reimbursable from the public health insurance system also when administered within out-patient care or when dispensed by pharmacies, the respective medicinal product must be listed in the “List of categorized medicinal products”.

The prices of partially or fully reimbursable medicinal products are set as maximal prices using the reference price calculation method of three lowest prices in EU countries. On the basis of individual decisions, the Ministry of Health determines the maximum covered by the public health insurance system, the maximum surcharge paid by the patient and the maximal price of the medicinal product in the pharmacy (this price includes the respective VAT, the wholesale and the pharmacy mark-ups). The list of the reimbursable medicinal products which contains, among others, these maximums, is published by the Ministry of Health. In addition, the price regulation issued by the Ministry of Health contains the regulation of maximal mark-ups for wholesale distributors and pharmacies with respect to medicinal products supplied to inpatient and outpatient clinics and pharmacies (subject to limitations specified in the price regulation). Over-the-counter medicinal products are not subject to price regulation. The similar price regulation of partially or fully reimbursable medicinal products and the regulation of maximal mark-ups for wholesale distributors and pharmacies apply on medical devices.

 

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

In general, the medicinal products and medical devices are fully reimbursable during inpatient care, if the patient is covered by the public health insurance and the healthcare provider is public or the private healthcare provider has in place the agreement with the health insurance company of the patient which covers the provided services.

In outpatient sector, the medicinal products and medical devices are fully or partially reimbursable, if they are included in the list of reimbursable medicinal products/medical devices on the basis of individual decisions of the Ministry of Health; the list also specifies the amount of the surcharge of the patient (if any). Otherwise, the patient has to pay for the medicinal products and medical devices in full.

In individual cases, the respective insurance company may pay its client the surcharge paid by the client for the partially reimbursable medical products/medical devices, or pay its client a part of the entire amount of the non-reimbursable medical products/medical devices provide (or even the entire amount in exceptional cases) if it is in line with the statutory provisions.

In comparison with the public health insurance, private health insurance is rather negligible in the Slovak Republic.

 

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

Medicinal products can only be dispensed in the hospital pharmacies, in the public pharmacies and in branches of public pharmacies. Medical devices can be dispensed in the hospital and public pharmacies, in the respective trading places for medical devices, or in optical shops (optical medical devices). The pharmacies and trading places for medical devices must have the authorization for provision of pharmacy services. Operation of optical shops is only subject to a trade license (a positive statement of the State Institute of Drug Control is, however, required).

These dispensers are compensated through the public health insurance system and by payments of patients.

 

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?

These responsibilities are primarily set out in the Act on Medicinal Products. The holder of the authorization for provision of pharmacy services must, inter alia:

• to secure the purchase of the medicinal products only from the manufacturers of the registered medicinal products, the holders of the marketing  authorization, the holders of the authorization for wholesale distribution of the medicinal products;
• provide the pharmacy services in line with the Act on Medicinal Products  and comply with the requirements of the good pharmacy practice and the  Slovak Pharmaceutical Code;
• to immediately notify the State Institute for Drug Control of suspected  adverse reactions to the medicinal products;
• to provide professional information about medicinal products, medical devices, to consult the determination and monitoring of a medical treatment;
• to provide information and counselling in such a way that ensures the effectiveness and safety of the treatment by the medical products and medical devices;
• n case of medicinal products reimbursable from the public health insurance, to inform the patient on the possibility to choose an alternative medicinal product and on the amount of the surcharge for all alternative medicinal products which can be dispensed on the basis of the respective medical prescription.

 

 

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Click the following links to read more legal articles from Slovakia:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs