The Pharma Legal Handbook: Uruguay

Important legal questions related to cannabinoid drugs, medicinal cannabis and opioid drugs in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes. We understand Cannabinoid Drugs as psychoactive cannabis for recreational non-medical use, as opposed to Medicinal Cannabis (understood as cannabis used for pharmaceutical purposes), the regulatory framework of which is described in “Medicinal Cannabis” below.

Law 19,172 defines psychoactive cannabis as flowering tops (buds), with or without fruit, of the female cannabis plant, except for seeds and leaves when separated from the stem, which have a natural tetrahidrocannabinol (THC) content equal to or greater than 1% of its volume.

 

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

The regulatory authorities with jurisdiction over Cannabinoid Drugs are the Institute for Cannabis Regulation and Control (IRCCA), the Ministry of Public Health (MSP), and the Ministry of Livestock, Agriculture and Fisheries (MGAP).

 

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

Yes. The regulatory framework related to Cannabinoid Drugs includes:

• Law 19,172 – “Marijuana and its derivates”. Passed on December 20, 2013, this Law establishes that “The State will assume the control and regulation of the activities of importing, exporting, planting, growing, harvesting, producing, acquiring under any title, storing, commercializing and distributing cannabis or its derivatives, or hemp, as applicable, through institutions to which it may grant legal mandates….”, with the IRCCA having the broadest powers of inspection and control.

Regarding advertising, Article 11 of the Law prohibits any kind of direct or indirect advertising, promotion or endorsement of Cannabinoid Drugs by any means of communications (print media, radio, television, cinema, magazines, filming in general, posters, billboards, brochures, banners, e-mail, Internet technologies, and any other pertinent type of media).

Article 13 of Law 19,172 provides that “The protection measures on social spaces established by art. 3 of Law 18,256 shall apply to psychoactive cannabis….” Article 3 of Law 18,256 prohibits smoking or keeping tobacco products lit in enclosed public places which are of public use or a workplace, also including “… enclosed spaces and unroofed interior spaces located within the built-up area.” Hence, the ban regarding smoking tobacco in public indoor places extends to cannabis.

Penalties (including criminal liability) for violations and offenses under the provisions of the Law include: warnings, monetary fines, confiscation and/or destruction of offending goods or items, suspension of licenses, closure of establishments, etc.

When passed, the Law was challenged by the United Nations as constituting a violation of existing international law under the argument that Uruguay would be adopting by law the 1988 “United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances” and several other international cooperation treaties that seek control, penalties, etc., for illegal transportation of drugs and substances, cannabis included.

• Law 14,294. This Law, which regulates narcotics use and commercialization, establishes in Article 3 (as amended by Law 19,172) that: “Plantation, cultivation, harvesting and marketing of any plant from which narcotic drugs or other substances causing physical or psychological dependence may be extracted shall be prohibited, with the following exceptions: a) When performed with the exclusive purpose of scientific research or for the development of therapeutic products of medicinal use. In such cases, plantation or cultivation must be authorized in advance by the Ministry of Public Health and shall remain under its direct control. Specifically, in the case of cannabis, plantation and cultivation must be authorized in advance by the IRCCA, and shall remain under its direct control….; b) Plantation, cultivation and harvesting, as well as industrialization and dispensing, of psychoactive cannabis for other purposes, provided that they are performed under the framework of current legislation and with prior authorization by the IRCCA, which shall remain under its direct control….; c) Plantation, cultivation and harvesting, as well as industrialization and commercialization, of cannabis for non-psychoactive use (hemp). Plantation or cultivation, in such cases, must be authorized in advance by the Ministry of Livestock, Agriculture and Fisheries and shall remain under its direct control….; d) Plantation, cultivation, harvesting, storage for research purposes as well as industrialization for pharmaceutical use, provided they are performed under the framework of current legislation and in accordance with regulations, which must have the prior authorization of IRCCA and shall remain under its direct control; e) Plantation, cultivation and harvesting of psychoactive cannabis plants by membership clubs, which shall be controlled by the IRCCA…”. Furthermore, Article 6 of this Law provides that both import and export of cannabis must have prior authorization from the MSP, which will issue the certificate allowing this activity.

The Ministry of the Interior shall have the task of “prevention, control and prosecution of all acts involving the import, export, production, manufacture, trading, marketing or illegal use of substances regulated by this law.”

• Decree 120/014. This Decree regulates Law 19,172 and consists of 104 articles, divided into five titles: “Psychoactive Cannabis for Non-medical Use,” “Cannabis Registry,” “Institute for Cannabis Regulation and Control (IRCCA)”, “Violations and Penalties”, and “Tax Provisions.”

Only three mechanisms are provided for use of Cannabinoid Drugs: purchase at pharmacies, membership in a cannabis club, or home-growing.

• Users purchasing Cannabinoid Drugs at pharmacies must register with the IRCCA, which guarantees personal data protection. Registration may be made by any legally competent person over 18 years of age with legal or natural Uruguayan citizenship or duly proved permanent residence in the country.

The maximum amount to be acquired may not exceed 40 grams per month per user, with a maximum of 10 grams per week. Cannabinoid Drugs are sold at pharmacies in 5-gram packages with warning messages concerning their health effects.

• Another way to acquire Cannabinoid Drugs is through “Cannabis membership clubs,” which also require registering, as civil associations with the Ministry of Education and Culture first, and then as grower clubs with the IRCCA. For this purpose, they must specify the growing location and appoint a technician in charge of the crop.

The aforementioned clubs shall have a minimum of 15 and a maximum of 45 members. If at any time a club has fewer members than the minimum required, it may be dissolved or, otherwise, a one-year term is given to reach the 15-member requirement.

• As a third option, consumers may also opt for home-growing, for which they must also register with the IRCCA. In this case, the regulations provide that household planting cannot exceed six plants, regardless of the number of persons living thereat or the family relationship among them. The maximum annual amount in this case is 480 grams.

Provisions are clear and establish that access to, and use of, Cannabinoid Drugs shall be exclusively as mentioned hereinabove, thus excluding all other types of businesses, such as sale at coffee shops, for instance.

Persons under 18 years of age will not have access to Cannabinoid Drugs (art. 14 of the Law).

• Decree 372/014. This Decree, in force since December 2014, allows “Plantation, cultivation and harvesting, as well as industrialization and commercialization, of cannabis for non-psychoactive use (hemp). Plantation or cultivation, in such cases, must be authorized in advance by the Ministry of Livestock, Agriculture and Fisheries and shall remain under its direct control.”

Hemp refers to plants or parts of plants of the Cannabis genus, leaves and flowering tops (buds), not containing more than 1% THC, including derivatives of such plants and parts of plants. The varieties of hemp seeds to be used may not contain more than 0.5% THC.

• Decree 128/016. This Decree prohibits the use at the workplace, allowing employers to establish preventive control measures and apply penalties, in coordination with the Ministry of Labor.

Pricing of Cannabinoid Drugs sold in pharmacies is made by the Uruguayan State through the IRCCA. The price is updated every six months based on parameters that take into account variations in exchange rates, salaries, and the Consumer Price Index. Currently, the retail price per 5-gram package of Cannabinoid Drugs amounts to $213 (two hundred and thirteen Uruguayan pesos, approximately USD 6.5). Pharmacies must sell the products to the customers at the established price.

Reimbursement is not regulated.

 

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

Four products have received market approval to date (Alfa I, Alfa II, Beta I and Beta II). These products correspond to ICC and Simbiosys, the only authorized companies to produce and distribute Cannabinoid Drugs in Uruguay.

Alfa I and Alfa II are indica-dominant hybrids, while Beta I and Beta II are also hybrids but with sativa-dominant characteristics. These strains have a moderate THC content (THC: ≤ 9%) and high cannabidiol content (CBD ≥ 3%), which makes them moderately psychoactive.

 

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid Drugs may be bought by any registered Uruguayan citizen. No prescription from a doctor is required.

 

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

No prescription from a doctor is required.

 

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

Distribution and production of Cannabinoid Drugs is made through two private companies (ICC and Simbiosys), which were licensed by the IRCCA in 2015 through a bidding process. These are the only two companies authorized to produce and distribute Cannabinoid Drugs.

Products are distributed by ICC and Simbiosys from the production site straight to pharmacies (art. 13 of Decree 120/014). Pharmacies are the entities authorized to sell the products to registered citizens (please refer to answer #3  above).

 

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

A list of pharmacies adhered to the dispensing network of Cannabinoid Drugs, which act as retailers for product sale to registered citizens, can be found on the IRCCA’s website https://www.ircca.gub.uy/farmaciasadheridas/

 

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

A bill of law has been recently submitted to Congress to include some plant species, preparations and substances under the control regime corresponding to the preparations contained in Schedule III of the Single Convention on Narcotic Drugs of 1961: flowering or fruiting tops of the cannabis plant (non-extracted resin), and cannabis resin, extracts and tinctures of cannabis, separated resin, whether crude or purified, obtained from the cannabis plant. This means that the control measures for substances included in Schedules I and IV of the said Convention shall not be applicable to said plant species, preparations and substances.

In addition, it establishes that THC shall be subject to the control regime corresponding to substances contained in Schedule III of the Convention on Psychotropic Substances, 1971, with the control measures set forth for Schedule I not being applicable thereto.

For its part, Dronabinol shall be under the control regime corresponding to the substances contained in Schedule IV of the Convention of Psychotropic Substances, 1971, not being applicable to the said substance the control regime provided for Schedule II.

The proposed changes are based on removing the obstacles that hinder the handling of cannabis products. The lawmakers presenting the bill express that “this is a way to promote national scientific research on cannabis, as our country has laws potentially useful for these purposes, while fostering the development of the domestic industry, creating jobs related to knowledge and innovation in connection with an international market that increasingly demands cannabis-derived products.”

 

10. When are they likely to come into force?

It was recently submitted to Congress, so, it is difficult to anticipate the political boost and support it may receive, or when or if it may come into force.

 

Medicinal Cannabis

11. Is Medicinal Cannabis authorized in the country?

Yes.

 

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

The regulatory authorities with jurisdiction over Medicinal Cannabis are the IRCCA and the MSP.

 

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

Decree 46/015, which regulates Law 19,172 in relation with medicinal cannabis, was published on February 10, 2015.

The decree regulates the use of cannabis for scientific research and for development of therapeutic products for medicinal use (plant specialties) and pharmaceutical purposes (pharmaceutical specialties).

The decree permits the use of cannabis for scientific and/or medicinal purposes, with the following scope:

1. Plantation;
2. Cultivation;
3. Harvest;
4. Gathering;
5. Marketing

I. Scientific Research: The decree defines scientific research as an activity aimed at developing research projects that contribute to the production of knowledge and scientific evidence regarding the use of cannabis.

The authorization for use of cannabis for this purpose is subject to compliance with the requirements indicated in this rule, accompanied by a research project, with presentation of a detailed report on the progress and the corresponding results before the MSP at the end of the project.

II. Pharmaceutical specialties and plant specialties: Pharmaceutical specialties are defined as any single or compound cannabis-based drug, with its name registered with the MSP, having a qualitative and quantitative formula declared as industrially produced and verifiable therapeutic properties, sold in certain sales units. Regarding plant specialties, the decree merely defines them as herbal cannabis or cannabis herb blends used for medicinal purposes.

There is no regulation related to pricing or reimbursement of Medicinal Cannabis.

 

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

Production and import of Medicinal Cannabis is regulated under Law 14,294 and Decree 46/015, as well as by the IRCCA and the MSP. Authorizations by the IRCCA and the MSP must be obtained to plant, cultivate, harvest, import, etc. medicinal cannabis.

The first step to apply for authorizations would be to establish a company in Uruguay and to register the same before the Cannabis Operator Registry of the IRCCA. Then, depending on the scope of the project, documents and information are to be submitted to the IRCCA and the MSP, which may include the requirements indicated in answer #3 of “Regulatory, Pricing, and Reimbursement Overview”.

In addition, prior to the grant of any of authorization, an approval from the Uruguayan National Bureau for Prevention of Money Laundering and Financing of Terrorism (SENACLAFT) is also required. SENACLAFT will analyze the legal background of the shareholders, the ultimate beneficiaries and the legality of the origin of the funds to be invested in the project.

 

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

Article 6 of Law 14,294 provides that both import and export of cannabis must have prior authorization from the MSP, which will issue the certificate allowing this activity.

To produce Medicinal Cannabis, authorizations from the IRCCA and the MSP are necessary as mentioned in answer #4 in “Medicinal Cannabis” below.

For the purposes of selling Medicinal Cannabis, the product must be registered with the MSP following the same procedure described in Question 3 in “Regulatory, Pricing, and Reimbursement Overview” if the product is registered as a pharmaceutical specialty, or as indicated in Question 1 in “Traditional Medicines and Over-the-Counter Products” if registered as a plant specialty.

 

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

As per Decree 46/015, only pharmacies authorized by the MSP may sell plant and pharmaceutical specialties based on psychoactive cannabis to the public, upon presentation of an official prescription.

Regulation for marketing and distribution of drugs (pharmaceutical) and plant specialties also apply to Medicinal Cannabis. Please refer to “Regulatory, Pricing, and Reimbursement Overview” and to “Traditional Medicines and Over-the-Counter Products”.

No Medicinal Cannabis may be advertised or sold without prior registration with the MSP. Rules regarding this matter are of the strictest nature and non-compliance is subject to criminal law.

 

17. How can patients obtain Medicinal Cannabis?

Medicinal Cannabis is to be sold exclusively in first and second category pharmacies. That means, in commercial pharmacies and the ones located at healthcare institutions.

Medicinal Cannabis must be prescribed by doctors by means of official medical prescriptions (Law 14,294, Decree 454/976, Decree 537/978 and Decree 46/015)

According to the regulations, Medicinal Cannabis may be obtained by legally competent persons over 18 years of age by presenting at the pharmacy the corresponding official medical prescription issued by the attending physician.

The prescription must specify the type of product indicated, its amount, and route of administration, as well as information of the patient.

 

18. Who can prescribe Medicinal Cannabis?

Doctors.

Decree 298/017 classified pharmaceutical specialties with cannabidiol active ingredient as “Prescription drugs” to prevent them from being sold as over-the-counter products directly to consumers.

 

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

Any doctor (legally registered in Uruguay as a Doctor of Medicine) is authorized to prescribe Medicinal Cannabis.

 

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

No approvals or notifications are required. Doctors can prescribe Medicinal Cannabis to their patients at their own discretion (art. 31 Decree 46/015).

 

21. Where is Medicinal Cannabis available?

Pharmacies.

 

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

No. Any pharmacy is authorized to sell Medicinal Cannabis to patients.

 

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

Please refer to answers to Questions 10 and 11 above.

 

Opioid Drugs

24. Are Opioid Drugs authorized in your country?

Yes, but under strict controls in terms of use, marketing and production processes.

 

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

The MSP is the regulatory authority with jurisdiction over Opioid Drugs.

 

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

These substances are mainly regulated by Decree-Law 14,294 and its regulatory Decree 454/976.

Without prejudice to the above, subsequent rules regulate these types of substances and update the contents of the Lists of controlled substances and narcotic drugs, using the lists of New York Convention as reference.

For the purposes of obtaining narcotics marketing authorization, the interested party(ies) must fill certain forms as specified by the MSP to be attached to the application for authorization to market the said narcotics, which shall include a statement to comply with the regulations in force.

 

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

Under Decree 209/018, the MSP established a list of substances considered to be narcotic drugs and psychotropics for which special authorizations must be obtained from the MSP.

To the extent an authorization is requested to manufacture or import products based on any of the substances included in the lists updated by Decree 209/018, the MSP must authorize the sale and use thereof pursuant to certain conditions set forth in Decree-Law 14,294 and its regulatory decree 454/976.

 

28. Who can prescribe Opioid Drugs?

According to the provisions of article 67 of Decree 454/976, doctors, dentists and veterinarians shall be entitled to make prescriptions, depending on the product and its intended use.

 

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

There are no lists. However, each professional must request a special prescription pad to the MSP in order to prescribe. These pads are for exclusive use of the requesting professional.

 

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

No approvals or notifications are required. Doctors can prescribe Medicinal Cannabis to their patients at their own discretion. Please also refer to Question 29 above.

 

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

To import, sell and distribute Opioid Drugs, organizations must be authorized by the MSP as described in “Regulatory, Pricing, and Reimbursement Overview”. Pharmacies are the only organizations authorized to sell the products directly to patients upon presentation of an official medical prescription.

Other than sale to the public, laboratories may sell to pharmacies or drugstores, or deliver originals to health professionals.

 

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

No. Any pharmacy is authorized to sell Opioid Drugs to patients.

 

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

No.

 

34. When are they likely to come into force?

Please refer to Question 33 above.

 

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Key legal info on regulatory reforms in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

Currently, a project to reform drugs regulations is being reviewed by the MSP (e.g. expedited proceedings, validity term of authorizations, etc.).

 

2. When are they likely to come into force?

Between the last quarter of 2018 and the first quarter of 2019.

 

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An insight into patents and trademarks in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

For trademarks, the basic requirements are novelty, fancifulness and originality. The trademark must be inherently registrable, that is to say, it cannot be descriptive of the goods or services it intends to identify and it must be clearly different from existing registrations/applications for the same or similar goods.

Basic patentability requirements are novelty, inventiveness and industrial application.

 

2. What agencies or bodies regulate patents and trademarks?

The local patent and trademark office is called Industrial Property National Office (DNPI) and is a government agency pertaining to the Ministry of Energy, Industry and Mining (MIEM).

 

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

The following are not considered inventions:

• Discoveries, science theories, mathematical methods.
• Plants and animals, except microorganisms and essentially biologic methods for the production of plants or animals, with the exception of non-biologic or microbiologic procedures.
• Schemes, plans, gaming rules, commercial, accounting, financial, educational, advertising, draw, auditing principles or methods.
• Literary, artistic, science and aesthetical works,
• Software per se.
• Information reproduction media.
• Biologic and genetic matter as existing in nature.

The following are not patentable:

• Diagnosis, therapeutic and surgical methods for the treatment of humans or animals.
• Inventions contrary to public order, good uses, public health, nutrition and safety or the environment.
• Second uses.

In principle products, substances and processes that are not included in the above categories and meet the patentability requirements would be protectable.

In theory there are no limitations to the goods and services that can be protected by a trademark.

 

4. How can patents and trademarks be revoked?

The decisions of DNPI which grant registration of patents and trademarks are subject to revocation actions. Any interested party who proves to have a personal, direct and legitimate interest can request revocation of these decisions. The deadline for filing a revocation action is only ten days as from receipt of official notice of the decision or publication thereof. If the revocation action is not successful a final appeal for the annulment of the decision can be filed with the Contentious Administrative Court.

Trademark and patent registrations are also subject to annulment.

Main grounds for annulment of a patent are:

• That it does not fulfill the patentability requirements or the grant is in some other way contrary to the legal provisions.
• That the specification is incomplete or inaccurate and does not permit to clearly identify the object of the invention.
• That the claims include matter that is not supported by the specification.

Main grounds for annulment of a trademark are:

• It is not inherently registrable.
• It is confusingly similar to a prior mark.
• It was granted without the authorization from a third party required in certain cases (such as signs that identify foreign states and international organizations, characters or other works protectable by copyright, the name and image of a specific person).
• It constitutes a reproduction, copy or imitation of a famous mark.
• It leads to presume that its owner intends to engage in unlawful competition

Trademark registrations are vulnerable to cancellation for non-use when not in use for a period of five years.

 

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

A foreign trademark not registered in Uruguay may be recognized, to the effect of preventing registration or seeking the annulment of a Uruguayan trademark in the following circumstances:

• if the foreign trademark owner can prove that the mark is locally well known and the Uruguayan mark constitutes a reproduction, copy or imitation thereof.
• if the foreign trademark owner can persuade the authorities by adequate evidence that the Uruguayan mark leads to presume that its owner intends to engage in unlawful competition.

Foreign patents are not enforceable in Uruguay.

 

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

No.

 

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

Apart from the items mentioned in answer #3 above, inventions which are contrary to public order, good customs, public health, public nutrition or the safety of the environment are not patentable. Trademarks that consist in expressions or drawings contrary to public order, morals or good customs are not registrable.

 

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

The registration of a patent or trademark license agreement with a foreign licensor before the DNPI is optional and not mandatory. In the case the license agreement is registered, the license shall be enforceable before third parties.

 

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The legal framework for product liability in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

Product liability could be attributed to the manufacturer, importer and/or the sales channel (to consumer) and it could be administrative (e.g. regulatory), civil or criminal depending on the defect and the harm caused by the product.

 

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

The Customer Protection Act No. 17,250 provides for a mandatory warranty for damages caused by defective products which shall be borne by the manufacturer and the importer. This liability expires after four years from the date in which the consumer knew or should have known of the damage or defect, with a maximum term of 10 years from the date in which the product was introduced into the market.

The manufacturer or importer could also be held criminally liable for placing in the market a product that represents a hazard to health (article 220 of the Uruguayan Criminal Code).

 

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

The Technical Department of the manufacturer is responsible for compliance with technical regulations in the manufacturing of products of each establishment and therefore, of the quality, security, efficacy and safety of products. Such responsibility may not be delegated, regardless of the manufacturer’s joint and several liability and of the quality assurance.

Corporate executives, employees and representatives could be held liable when the claimed act was caused by willful misconduct, fraud, gross negligence, negligence, etc.

 

4. How can a liability claim be brought?

A liability claim can be brought by different ways:

1. administrative (e.g. by filing a claim before the Consumer’s Protection Department or Ministry of Health);
2. civil claim before Civil Courts;
3. criminal claim before Criminal Courts.

 

5. What defenses are available?

Defenses are not limited and will depend on the case and the object of the claim.

 

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The key facts about traditional medicines and OTC products in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

Regarding medicines and devices please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.

Decrees 403/016 and 404/016 state that any company undertaking operations with herbal medicines, vegetable drugs, vegetable raw materials with pharmacological activity, vegetable products, phytotherapic medicines and homeopathic medicines must do so in establishments authorized to such ends and with a valid authorization of the MSP, which shall comply with the “Good Manufacturing and Control Practices” and the “Good Practices on Storage, Distribution and Transport”.

In order to register herbal medicines, vegetable drugs, vegetable raw materials with pharmacological activity, vegetable products and phytotherapic medicines the same requirements detailed for drugs apply (Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.)

In the case of homeopathies (Decree 404/016), besides what is foreseen for drugs (Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview) the following must also be submitted:

1. analysis of intermediate products;
2. complete analysis of all raw materials;
3. microbiological analysis of the final product;
4. master formula;
5. manufacturing order;
6. stability study (organoleptic, pharmacotechnical and microbiological characteristics).

 

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

Rules related to medicines advertising apply to these types of products (Decrees 403/016 and 404/016). In this context, please refer to Question 17 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

Rules related to medicines advertising apply to these types of products (Decrees 403/016 and 404/016). In this context, please refer to Question 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

Regulatory requirements for over-the-counter (non-prescription) medications are the ones described for general drugs in the Regulatory, Pricing, and Reimbursement Overview. Advertising of over-the-counter products is allowed, as referred to Question 17 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

Please refer to Question 17 and 18 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

Please refer to Question 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

Yes. Please refer to Question 17 and 19 in Marketing, Manufacturing, Packaging & Labeling, and Advertising overview.

 

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

There is no legal mechanism. Depending on the change of the registered product (e.g. formula, indications, adverse effects, etc.) a new registration or an amendment to the already existing registration must be requested.

 

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

Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.

 

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All about marketing, manufacturing, packaging & labeling and advertising in Uruguayan pharma. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.

 

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

Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview.

 

3. What are the typical fees for marketing approval?

Please refer to Question 4 in Regulatory, Pricing, and Reimbursement Overview.

 

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

Please refer to Question 5 in Regulatory, Pricing, and Reimbursement Overview.

 

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

After the creation of the Pharmacovigilance National System by Ordinance No. 798/2014, Laboratories must notify the Pharmacovigilance Unit of the MSP of the identified events (Adverse Drug Reactions -ADR-, Medication Errors -ME- and Events Supposedly Attributable to Vaccination and Immunization -ESAVI-):

• Within 24 hours, in the event of death or risk that involves a large number of persons. Communication must be immediate with the aim of implementing the corresponding actions early;
• Within 48 hours at the most, in those cases of severe ADR or ESAVI, which do not imply a greater population risk;
• Within a maximum term of 15 business days, in all other cases which do not meet the criteria referred to above.

Likewise, Laboratories must:

• Report regularly and when requested by the Pharmacovigilance Unit.
• Enter in a database all notices received.
• Develop methods to obtain early warning signs.

Laboratories must appoint a responsible person for Pharmacovigilance who shall be the valid speaker before the MSP.

 

6. Are foreign marketing authorizations recognized?

Yes. Foreign marketing authorizations are recognized and required (as mentioned in Question 3 of Regulatory, Pricing, and Reimbursement Overview.) to register products. Although foreign market authorizations speed-up the registration process they do not avoid the need to go through the registration process and to submit all documents indicated in Question 3 of Regulatory, Pricing, and Reimbursement Overview.

 

7. Are parallel imports of medicines or devices allowed?

No. A product which is imported to Uruguay must be registered, except in the case of health emergency or “compassionate use” (express authorization of the MSP regarding unregistered products requested by patients and prescribed by their treating physicians).

 

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?

In Uruguay there are no restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for individual private medical practitioners.

However, article 198 of Law 18,996 states that: “The National Resources Fund shall require persons financially or technically related to said body to declare any conflicts of interest that may arise in connection with the sale, production, financing or use of certain technologies, devices, medical acts or drug products.”

The FNR requires medical practitioners to fill out an online form for declaration of conflicts of interest, which acts as a sworn statement.

The “declaration of conflicts of interest form”, with which the FNR regulates the provisions of article 198, establishes that:

• The potential conflict of interest exists regardless of whether the medical practitioner considers that these relationships have influence over their scientific opinion or their commercial or financial performance. In this sense, whenever drugs, products or services provided by the FNR are prescribed, the declaration must be filed, irrespective of the subjective criterion of each professional.
• Potential conflicts of interest can be: i) personal: they imply direct personal benefits such as fees or other compensation in favor of the medical practitioner, their spouse or their children; ii) non-personal: involving funding for a department or unit to which the medical practitioner belongs, even if this funding or benefit is not received directly (e.g. aid to create units or departments, support for hiring personnel, research funding, etc.)
• Any relation that involves receiving financial support for attending meetings and conferences (registration, travel grants, etc.) or being employed or providing services to a pharmaceutical company or entity that supplies medical devices or services to the FNR must also be declared.

On the other hand, the Anticorruption Act No. 17,060 and Decree 30/003 expressly prohibit government official (e.g. medical practitioners from public health institutions) from engaging in the following conducts, among others:

1. having a relationship with companies who submit bids in tenders of the institution they work at;
2. being involved in government contracts when related by family to the contracting parties;
3. receiving money, gifts, benefits, favors or other advantages, for his/herself or for others, for doing, accelerating, delaying or omitting acts pertaining to the government’s official position, or for an act already performed;
4. intervening in decisions on matters in which s/he has participated in a technical capacity;
5. being an employee, advisor, auditor, consultant, partner or director of individuals or public or private legal entities subject to oversight of offices to which the government official pertains. Government officials are likewise prohibited from receiving retributions, commissions or fees of any kind whatsoever from such persons. The prohibition extends to all contracting of services or works performed at the request of the overseeing Administration, by international organizations or by execution of projects by third parties. This applies to government officials who hold senior direction, inspection or advisory positions.

The following are permitted:

1. travel and stay expenses received from governments, educational institutions or nonprofit entities, to give talks, courses or academic or cultural activities, or participate therein, provided same is not incompatible with the government official’s functions or prohibited by special rules;
2. reasonable gratifications received on the occasion of traditional holidays in accordance with conditions of accepted use and custom.

 

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

Please refer to Question 1 in Regulatory, Pricing, and Reimbursement Overview.

 

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?

Yes, local manufacturing requirements are compatible with GMPs. However, the MSP is currently applying the 37th report of the World Health Organization which is not the latest report issued by said organization.

 

11. What is the inspection regime for manufacturing facilities?

MSP is the authority responsible for inspecting manufacturing facilities with full powers. In practice, the first inspection is planned and previous notification of the inspection date is given to the manufacturer. Other inspections could take place in a “surprise” regime to evaluate:

1. compliance of the facilities with GMPs and standard operating procedures;
2. whether activities do not exceed the limits set by the authorization and do not differ from those activities which are authorized;
3. performance of validation analysis of the manufacturing processes and systems involved.

 

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

There are no specific regulations on this matter.

 

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

Despite the fact that there are no specific regulations regarding all storage, warehousing and packaging requirements of pharmaceutical products, Decree 521/984 sets forth the facilities’ requirements of public or private industrial establishments. The Decree clarifies that such requirements should be deemed to be generic and minimum and that other conditions for approval of facilities and operations of establishments may be determined. Likewise, Uruguay adopted through Decree 440/016 the Good Manufacturing Practices for Pharmaceutical Products, Report 37 of the World Health Organization, so such guidelines would also be applicable.

In this sense, establishments must operate in facilities built with adequate materials and located in such a way that they allow for adequate operability, easy cleaning, maintenance and flow of materials.

They should be connected to the public water supply network and/or have a personal water supply source regularly analyzed and approved in accordance with regulations on potable water. They should have water storage tanks as well as the necessary equipment to ensure the water quantities to be used in the manufacturing of pharmaceutical products, and analysis and tests made should be documented.

Walls should be tiled, oil-based epoxy painted or similar up to two meters height, angles should be sanitary and convex. Surfaces of warehouses and other facilities not assigned to manufacturing should be capable of being bleached.

Paving or other cladding of the floor should be solid and flat and slippery so as to make cleaning easy.

In those places in which operations may cause floor moisture, there should be adequate sewers or drains.

Facilities must count with adequate space for the installation of the necessary equipment and tools.

Facilities must have and ensure: a) direct access to public streets; b) adequate ventilation and lighting; c) equipment for the control of physical and biological conditions when required for manufacturing; d) adequate water filtration in manufacturing areas when necessary; e) extraction systems close to dusty operations which eliminate all contamination risks; f) separate operating systems for the handling of highly active allergenic substances.

Facilities must have sewage, entry, storage and fluid distribution conditions, elimination of waste products which ensure hygiene and avoid the risk of product, personnel and environmental contamination.

Industrial establishments using laboratory animals must have adequate accommodation and space, separate from manufacturing and storage areas.

If within one same establishment tasks other than the manufacturing of drugs are undertaken, these tasks must be performed in such a way as to avoid cross-contamination. Administration, storage and sale of products and personnel’s break spaces must be separated and isolated from manufacturing places.

Operations must be carried out within industrial areas specifically defined and individualized for the administration and reception of public, as well as for: a) storage and quarantine of raw materials and packaging materials; b) storage of approved materials; c) storage of semi-manufactured products; d) storage of rejected materials before disposal in order to avoid their use; e) simultaneous manufacturing, fractioning and packaging operations in which special conditions require so; f) keeping pharmaceutical products quarantined before being released; g) storage of pharmaceutical products after approval; h) performance of all quality control operations; i) in the case of aseptic products, areas must be isolated, conveniently installed and controlled and operate with an adequate methodology which ensures that the products manufactured therein are free of contaminating agents. Special cares regarding clothing, equipment, entry of sterile air, positive air pressure, cleaning and sanitizing are required.

Industrial establishments must comply with the following regulations: a) keeping all facilities clean and in good state of preservation; b) keeping all facilities free of waste, insects and rodents; c) preparing detailed cleaning proceedings in writing; d) only using those cleaning materials which do not cause contamination of products, equipment and packaging material.

 

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

Labelling of products must be in Spanish and varies depending on the product:

Decree 324/999 states that labeling of drugs (cases, packaging and prospectus) must contain, among others:

1. name of the pharmaceutical product;
2. pharmaceutical form;
3. preparation for sale and content;
4. instructions in relation to: route of administration; instructions; dosage; contraindications; collateral, adverse, undesirable, harmful or toxic effects;
5. expiration date;
6. category regarding consumption;
7. name of the manufacturing establishment and/or import representative;
8. registration number of the establishment and registration number of the drug;
9. batch number;
10. storage and preservation precautions;
11. name of the responsible technical director.

In addition to the aforementioned requirements, Decree 38/015 states that biosimilars must be identified as such. The biosimilar’s prospectus information must be as similar as possible to that of the reference biological, in particular as regards dosage and safety information. If the similar has less information than the reference product, express mention of this fact must be included in the prospectus.

For its part, the labelling of medical devices regulated by Decree 3/008 must contain, among others:

1. name of the product and content of the packaging;
2. batch number: if appropriate, manufacturing date and term of validity or date before which it must be used;
3. name and address of manufacturer and importer and country of origin;
4. egistration number of the product before the MSP and name of the responsible technical director;
5. instructions for use;
6. date of sterilization (if applicable), method and expiration;
7. conditions for storage, preservation and/or handling and its condition as a reusable product, if applicable;
8. any warning and/or precaution which must be followed.

 

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

It is possible to formally ask the MSP to allow other information. MSP has discretionary powers to allow the inclusion of additional information depending on the product, category, etc.

 

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

MSP has discretionary powers to allow or not certain items depending on the product category, etc.

MSP will not allow any information which is wholly or partially false or which in any other way, even due to the omission of essential information, might be misleading for the consumer regarding the nature, quantity, origin, etc. of the product. It is also not permitted to register drugs with names directly referring to the illness or to include images promoting the use of products by children, among others.

Likewise, MSP will not authorize items in the labelling which are not strictly concordant with the information submitted by the manufacturer or importer to the MSP.

 

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

Law 15,703 and Decrees 521/984 and 18/989 only allow the marketing of medicines and medical devices to the public through authorized pharmacies.

For its part, as regards advertising:

1. it is only allowed regarding products duly registered with the MSP (reference to drugs which have not been registered, even if indirectly, is not allowed);
2. over-the-counter drugs are the only category in which direct advertising to the public may be made through different means and;
3. all material and information which refers to drugs belonging to a different category (e.g. prescription drugs) must only be directed to healthcare professionals (physicians, chemical-pharmaceuticals, etc.).

Regarding advertising of biologicals, which is limited to healthcare professionals, article 23 of Decree 38/2015 states that “when registering or renewing a biotechnological drug, all advertising and promotion projects directed to health professionals must be submitted to the health authority. (…)”.

All information material in relation to medical devices which must be handled by healthcare professionals or for which patients need the involvement of a healthcare professional (e.g. tomographs, vaporizers, etc.) must be exclusively directed to these and/or to regulated sales channels (e.g. healthcare institutions, clinics). This is the interpretation of the MSP since there is no express law regulating this matter.

 

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

Medicines and devices can be sold to the public only through authorized pharmacies. Medicines and devices cannot be sold via post. The only exception for selling drugs via post is under the “compassionate use” proceeding (regulated under Resolution No. 692/013). The mechanism consists of allowing the patient to import products that still do not have a market authorization in Uruguay or that are in the process of clinical development, upon a specific prescription from the treating physician.

 

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

Over-the-counter drugs are the only category of drugs which may be the object of direct advertising addressed to the public through different means. There are no limitations as regards the places where to advertise but all advertising must meet the following criteria:

1. it must refer to products duly registered in Uruguay;
2. it must be strictly concordant with the information submitted by the manufacturer or importer to the health authority;
3. it must contain information which is clear and true and adhere to the accuracy, impartiality and objectivity of the information;
4. it may not contain ambiguous information which might be misleading for the consumer as regards its use and be therefore detrimental to health;
5. if reference is made to the treatment of symptoms or illnesses, the advertising must include the suggestion to seek medical advice (in dimensions that will depend on the context of each advertising);
6. in the event there might exist harmful effects to health due to misuse, for example, the advertising must include a warning to seek medical control.

 

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

Please refer to Question 17 abovementioned.

 

21. How is compliance monitored?

Please refer to Question 8 in Regulatory, Pricing, and Reimbursement Overview.

 

22. What are the potential penalties for noncompliance?

Please refer to Question 9 in Regulatory, Pricing, and Reimbursement Overview.

 

Also from this Legal Handbook

Preclinical and clinical trial requirements in Uruguay –  a legal guide. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

No.

 

2. How are clinical trials funded?

Clinical trials can be funded by a promoter (individual, company, institution or organization responsible for the start-up, management and/or financing of research) or by a Sponsor (individual or legal entity which supports the financing or finances research), as defined by Decree 379/008.

 

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

Protocols must comply with the requirements of international regulations applicable to research on human beings and requirements set forth by Decree 379/008 and Ministerial Ordinance 827/016: description of the trial, risks and benefits, responsibilities of the Researcher, Institution, Promoter and Sponsor; financial plan, information on research participants, description of the characteristics of the population to be studied, submission of the research specific consent form, among others.

The preclinical and clinical trial protocols must be approved by the Institutional Ethics Committee of the Institution where research is conducted. Research on new drugs, vaccines, diagnostic tests, healthcare equipment and devices must be informed and –depending on their reach- approved by the National Commission of Ethics in Research, which shall send its assessment to the General Healthcare Directorate of the MSP. Depending on the reach of the project, other ministerial authorities may be involved in the process of approval.

 

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

The free and previous consent of participants is required. The consent for clinical trials should inform all participants of:

1. justification, objectives and research proceedings;
2. any discomfort, possible risks and expected benefits;
3. existing alternative methods;
4. follow-up and care, responsible persons;
5. duration of participant’s involvement;
6. the right of the person to refuse to participate or to withdraw his/her consent at any stage of the research, with no sanctions and regardless of the care that will be provided;
7. method of reimbursing expenses incurred due to participation in the research;
8. compensation vis-à-vis possible damages caused by the research;
9. how to communicate with and access the researchers during the study.

In addition, for the free and informed consent to be valid, it shall meet the following requirements:

1. be prepared by the responsible researcher;
2. be approved by the Research Ethics Committee;
3. be signed or identified by digital printing, by each and every research participant or legal representatives and by the responsible researcher;
4. be issued in two counterparts: one to be given to the research participant or legal representatives and another one to be filed by the responsible researcher.

 

5. May participants in clinical trials be compensated?

There are no regulations as regards compensation for participants in clinical trials.

However, Decree 379/008 states that expenses incurred by research participants within the framework of the trial may be reimbursed as long as the amount of such expenses is not such that it may interfere with the decision-making autonomy of the participant or its legal representatives.

 

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

Decree 379/008 states that participants in clinical trials who suffer damages of any nature (whether foreseen or not in the terms of the consent) resulting from their participation, in addition to the right to a comprehensive assistance, shall have the right to compensation. Under no circumstance may the research participant be required to waive the right to compensation for damages. The free and informed consent form must not include any term which reduces this liability or which implies that the research participants have waived their legal rights, including the right to compensation. Any term and condition in this sense will be void.

 

Also from this Legal Handbook

A brief overview of the situation regarding regulatory, pricing and reimbursement in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.

 

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

The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals and medical devices is the Ministry of Public Health (MSP), which is part of the Executive Branch.

 

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

The regulatory framework for the authorization of drugs, biologicals and medical devices is mainly comprised of Law 9,202 (MSP Organic Law), Law 15,443 (Drugs Law), Decree 521/984, Decree 324/999 and Decree 12/007 (Drugs), Decree 3/008 (Medical Devices) and Decree 38/015 (Biologicals). These regulations are supplemented by other decrees, resolutions and ordinances published by the MSP.

Price control in the private sector is not regulated.

In Uruguay, there is no reimbursement in the private sector.

Notwithstanding, the National Resources Fund (FNR), an institution created by Decree-Law 14,897 as a non-state public entity, provides financial coverage for some highly specialized medical procedures and high-cost drugs to the users of the National Integrated Healthcare System. Also, the National Reference Center on Congenital Defects and Rare Diseases (CRENACEDER), which is part of the Social Security Institute (BPS), provides drugs for treatment of rare diseases.

 

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

Pursuant to Law 15,443 and Decree 521/984 manufacturers or importers must obtain an authorization of the MSP in order to test, develop, import and market products (authorizations are granted for product category, e.g. drugs, biologicals, medical devices, homeopathic, etc.).

In order for a company to obtain authorization as a manufacturer or importer, the company must be incorporated in Uruguay, have a responsible technician holding a Uruguayan accredited degree, a warehouse (either own or outsourced) and a manufacturing plant (in the case of manufacturers). Likewise, the company must submit documentation such as facilities authorizations (e.g. Municipality, National Fire Department, Hygienic and Environmental, Potable Water, etc.), operational procedures, list of products to be manufactured/imported, outsourced agreements if any (e.g. technical service for medical devices, product testing, storage). The companies’ authorization proceedings may take approximately between four and eight months if no objections are raised and considering it is the company’s first request for authorization.

Also, in order to sell products in the Uruguayan market, manufacturers or importers must obtain a marketing authorization -granted by the MSP- for each particular product.

Marketing Authorizations: Requirements and timeframes vary among drugs, biologicals and medical devices. Each category of product has its own regulation indicating the requirements (documentation and information) for registering the product and obtaining marketing authorization.

For drugs and biologicals, qualitative and quantitative tests must be performed in finished products. In the case of the import of finished products, before registration, the importer must submit to the MSP:

1. a power of attorney granted to the importer by the foreign manufacturer authorizing the importer to distribute the products in Uruguay and;
2. a GMP/CPP evidencing that the foreign manufacturer is authorized by its country’s regulatory authority.

Drugs: Decree 324/999 states that in order to register a drug, the manufacturer or importer must inform and submit to the MSP, among others:

1. name proposed for the drug;
2. qualitative – quantitative formula;
3. monograph of active or inactive raw materials;
4. pharmaceutical form;
5. methodological analytics of the finished product;
6. description of the characteristic of the pharmaceutical form;
7. qualitative analysis of active raw materials in the finished product;
8. quantitative analysis;
9. hygienic control of the non-sterile finished product;
10. sterility control of pyrogenics and safety, as applicable;
11. stability study of active raw material/s;
12. updated pharmacological basis of the foreseen therapeutic effect of active raw material/s. The submission of further documentation might be necessary -for demonstrating interchangeability and bio-comparability- depending on whether raw materials are already present in other registered drugs or drugs pending registration or whether they have been approved or not by FDA or EMA;
13. draft prospectus;
14. labeling design.

The approval timeframe depends on the type of proceedings followed:

1. expedited: 30 days approx.;
2. standard: 12-18 months approx.

Biologicals and Biosimilars: Decree 38/015 sets forth the requirements to grant the marketing authorization for biologics and biosimilars. Besides the information and documentation for drugs set forth by Decree 324/999, the following must be submitted, among others:

Biologicals:

1. GMP of the active ingredient’s manufacturer;
2. evidence of marketing in other countries, in the case of imported products;
3. information on active ingredient/s;
4. information on the pharmaceutical product;
5. preclinical information: pharmacodynamics studies, pharmacokinetic studies, toxicity;
6. clinic information: phase I, II, III and IV studies (if applicable), immunogenicity studies;
7. pharmacovigilance and risks managing plan.

Biotechnological Similar Drugs:

1. GMP of the active ingredient’s manufacturer;
2. evidence of marketing in other countries, in the case of imported products;
3. information on active ingredient/s;
4. information on the pharmaceutical product;
5. quality comparability protocol;
6. preclinical comparability protocol;
7. clinical comparability protocol: pharmacokinetic and pharmacodynamics studies, including confirmatory clinical trials to demonstrate the similarity of efficacy between the biosimilar and the reference biologic;
8. efficacy studies;
9. security studies;
10. immunogenicity studies.

The approval timeframe for biologicals and biosimilars takes approx. 12-18 months.

Medical Devices: Decree 3/008 sets forth the information and documents to be filed before the MSP in order to obtain a marketing authorization for medical devices, which are, among others: (i) MSP Form; (ii) copy of the company’s approval at the MSP; (iii) in the case of imports, Free Sale Certificate at the country of origin; (iv) complete dossier with technical information on the product.

The approval timeframe takes approx. 6 months.

 

4. What are the approximate fees for each authorization?

MSP fees for the company authorization (as manufacturer or importer) depend on the area of the premises and number of employees of the company. In case of an importer with an outsourced storage, fees amount to 1 Readjustable Unit (USD 35 approx.)

MSP fees for product registration are:

Drugs:

Depends on the proceedings to be followed:

1. expedited: 50 Readjustable Units (USD 1,750 approx.) plus 5 Readjustable Units (USD 175 approx.) per active ingredient in the product or
2. standard: 30 Readjustable Units (USD 1,050 approx.) plus 5 Readjustable Unit per active ingredient in the product. MSP has discretionary powers to decide whether or not to accept expedited requests and a maximum of 5 expedited requests is being accepted per registering party.

Biologics and Biosimilars:

5 Readjustable Units (USD 175 approx.).

Medical Devices:

30 Readjustable Units (USD 1,200 approx.).

 

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

Marketing authorizations are valid for five years. Marketing authorizations must be renewed every five years. Non-compliance with filing the renewal request before the end of the five year term will cancel the registration and a new registration process shall need to be followed.

For renewal, applicants must evidence compliance with good manufacturing practices, safety and efficacy standards, pharmacovigilance, labeling standards and all other applicable provisions.

 

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

In general terms the differences are that for brand-name products it is necessary to evidence safety and efficacy and for generic products it is necessary to evidence interchangeability and bio-comparability.

There are no differences between local manufacturers versus foreign-owned manufacturers in the authorization processes.

 

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

There is no regulation related to combination products. Combination products must obtain marketing authorization from MSP. Given their particular features, combination products can be classified either as drugs (drug/biologic) and/or medical devices (drug/device). Requirements and application timeframes differ in each case. Depending of the nature of the combination product, it may require separate drug or biologic and medical device approvals or not.

 

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

MSP is the authority responsible of monitoring and assessing compliance with regulations. MSP has a permanent pharmacovigilance program based on information on possible adverse effects of drugs, provided, among others, by:

1. doctors and physicians;
2. pharmaceutical companies that manufactured or imported the products and those who conduct clinical trials, who must both report any health risks.

Under the Health Law Regulations, MSP’s monitoring is focused on ensuring, among other things:

1. compliance with good manufacturing practices and standard operating procedures;
2. that activities do not exceed the limits set by the authorization and do not differ from those activities which have been authorized;
3. performance of validation analysis of the manufacturing processes and systems involved.

Although the regulatory regime is comparable to the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements, the MSP does not undertake such an active control as the one undertaken by these agencies and, in practice, sanctions applied by the MSP are different.

 

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

MSP is empowered to make on-site visits at any time to inspect premises and verify compliance, and can initiate ex officio administrative proceedings to sanction non-compliance. Ultimately, these administrative proceedings can result in warnings, confiscation of products, revocation of the marketing authorization, ordering partial or total suspension of activities, closure of establishment and sanctions ranging between 30 to 1,000 Readjustable Units (USD 1,050 to 35,000 approx.)

 

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

Laws 18,131 and 18,211 regulate the National Integrated Healthcare System.

Within the framework of such system, a National Healthcare Fund (FONASA) was created, which is managed by the National Health Board (a body which is part of the MSP).

FONASA receives mandatory contributions from employed personnel, both private and public, employers, independent professionals, personal services one-person businesses providers and retired workers.

FONASA finances the National Healthcare Insurance through which employed personnel, independent professionals, personal services one-person businesses providers and retired workers have the right to health coverage for themselves and for their families at any of the healthcare providers which are part of the system.

Healthcare providers charge FONASA a price per insured person which is called healthcare fee.

The healthcare fee is comprised of two elements: (i) capita: an amount adjusted to the coverage risk which varies according to the age and gender of the insured person, in accordance to certain criteria set by the government, (ii) goal: this part of the price is only charged when the healthcare provider fulfills the quality and sanitary objectives set by the National Integrated Health System.

The public healthcare sector normally implements measures to limit costs, for example, by pressing for price reductions in public bids and encouraging competition.

 

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

Both, public healthcare system and private healthcare providers are part of the National Healthcare Insurance, so users may decide to join any of them.

Likewise, users who are not part of the Insurance (for example, because they are unemployed and do not have a family member under whom they are provided coverage) may be assisted either at the public or private sector. In these cases, such coverage has a cost.

Free healthcare coverage is only granted to persons who do not reach a certain level of income.

There currently exist complementation agreements between public and private institutions with the aim of complementing their services.

 

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

Prices of drugs and devices are not regulated in Uruguay.

 

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

Users of public and private healthcare services providers can access certain drugs and medical examinations by paying a certain price, whose maximum amount is set by the government as “moderating rates”.

The MSP issues a list (Drug Therapeutic Formularium) which determines the drugs which healthcare providers must provide under the moderating rates regime.

This allows healthcare providers to purchase large volumes of drugs which gives them significant negotiating powers.

Moreover, users also have the possibility of acquiring drugs at pharmacies by paying the corresponding amount (this amount is set freely by pharmacies).

As regards medical devices, companies which manufacture, import, store, distribute or are involved in their maintenance or repair must obtain prior approval of the MSP. Likewise, medical devices must be registered in order to be marketed.

Also, the FNR provides financial coverage for some highly specialized medical procedures and high-cost drugs to the users of the National Integrated Healthcare System.

 

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

Pharmacies authorized by the MSP. Healthcare institutions have the possibility of having their own pharmacy in order to dispense drugs to their users.

 

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?

The MSP investigates dispensing errors that are reported to it.

Law 15,703 states that Technical Directors of Pharmacies are legally responsible for the correct dispensing of drugs and devices.

Healthcare professionals who prescribe drugs or devices could be responsible vis-à-vis patients for the prescribed treatment and for the information provided in relation to such treatment.