Legal & Regulatory > Argentina > Marketing, Manufacturing, Packaging & Labeling Advertising

Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.

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

See answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview.

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

See answer to Question 6 in Regulatory, Reimbursement and Pricing Overview.

3. What are the typical fees for marketing approval?

See answer to Question 4 in Regulatory, Reimbursement and Pricing Overview.

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

See answer to Question 6 in Regulatory, Reimbursement and Pricing Overview.

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

Pharmaceutical companies must comply with local Good Pharmacovigilance Practices. Likewise, pharmaceutical companies must appoint a professional within its company who assumes connection functions with the health authority (through its Pharmacovigilance Department) to exchange information regarding adverse effects on medicines marketed by such pharmaceutical company.

6. Are foreign marketing authorizations recognized?

Yes, but only for product registration purposes (Argentina allows registration based on similarity, please see question 6 in Regulatory, Reimbursement and Pricing Overview above for more detail). Any product to be marketed in Argentina needs to previously obtain the relevant MA with ANMAT.

7. Are parallel imports of medicines or devices allowed?

Yes. The Argentine Supreme Court has accepted the validity of the so-called “parallel imports” in trademark matters. The Trademark Law does not include a specific provision for the “grey market” importation of pharmaceuticals. However, there is some old case law by the Argentine Supreme Court allowing parallel imports. This case law applies the so-called “international exhaustion” of rights.

Case law only refers to “parallel importation” of legitimate products. If the product is altered or if illegitimate products are imported, the trademark owner may seek injunctive relief with the Argentine Courts. If products are legitimate but substantially altered for sale in Argentina, the right holder could also have legal standing to object their import.

With regard to patents, the Patent Law also provides for an international exhaustion regime.

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 relationship between pharmaceutical companies and Healthcare Professionals (“HCPs”) is regulated and the regulation provides several ethical standards and guidelines that must be followed, particularly, on how the information to HCPs should be presented and how pharmaceutical companies should manage their relationship with HCPs without inducing them to prescribe their products, being thus motivated by non-ethical incentives instead of being the prescription a consequence of a professional decision based on scientific evidence. This regulation was enacted to tackle promotional practices that foster commercial circuits that jeopardize good practices for prescribing and that affect the rational use of drugs.

Promotional activities for prescription drugs are subject to the following principles:

1. the promotion of a medicine that has not obtained the corresponding MA is forbidden;
2. all the contents of the promotion of medicines are adjusted to the characteristic identifying data appearing in the MA; and
3. in any case, the promotion of medicines must favour their rational use, presenting them objectively within the framework of their pharmaceutical properties, therapeutic action and indications so approved (on-label). In this sense, the technical-scientific information necessary for the recipient to know about the therapeutic properties of the medicine must be provided.

Scope of the MoH Regulation No. 627/2007 is applicable to the:

1. promotion of medicines sold under prescription addressed to professionals licensed to prescribe or dispense medication;
2. promotional visits by reps, medical promotional agents or persons authorized by pharmaceutical companies, addressed to professionals licensed to prescribe or dispense medicines;
3. (supply of free samples, samples for professionals, samples without commercial value or similar samples;
4. sponsorship of promotional meetings where professionals licensed to prescribe or dispense medicines attend;
5. sponsorship of scientific conferences where professionals licensed to prescribe or dispense medicines participate;
6. incitement to prescribe or dispense medicines through the granting, offer, promise of monetary or in kind advantages, except when their intrinsic value is minimum; and
7. promotion, offer, commercialization of medicines made through web pages and/or electronic mails and/or in any other way over the Internet.
8. MoH Regulation No. 627/2007 prohibits the granting, offering or promising by the pharmaceutical companies and/or in their name and on their representation, of any kind of incentive or benefit such as premiums, monetary or in kind advantages or otherwise to HCPs and/or to persons related or close to them. Awards granted by pharmaceutical companies to the participants in the commercialization chain (distributors, drugstores and licensed pharmacies) are the only exception to this prohibition, when this is part of their commercial policy.

This Regulation sets-up the basic framework applicable to: (i) the process for granting scholarships to HCPs and (ii) sponsorship of promotional/educational events. Section 16 aims to provide equitable and clear mechanisms, not based on prescription, for the selection processes of HCPs who apply for scholarships. Thus,  to achieve the “equitable and clear mechanism” required by law, the proposed process should be based on objective standards (i.e.,: qualification, experience, etc.) and can never be based on the prescription of products. Considerations on the publication, terms and conditions, candidate selection process, scholarship reporting, etc., are issues that should be considered when drafting internal policies.

MoH Regulation No. 627/2007 does not distinguish whether a promotional activity is conducted under a scientific, educational, or strictly promotional event addressed exclusively to HCPs. The general principles established in said regulation are applicable for any event.

In regard to the promotion and advertising of medical devices intended for professional use only, it is not yet regulated in Argentina (there is a legal gap). Therefore, it cannot be specified which modes of advertising are expressly permitted when it comes to medical devices intended for professional use only.

There is a legal gap regarding the relationship between medical devices’ companies and HCPs; thus, it would be advisable to consider the ethical standards of MoH Regulation No. 627/2007 to be used as practical guidelines for the medical devices industry, under a conservative approach.

Finally, also consider that the pharmaceutical and medical devices industry relies its common practices on rules contained in its applicable code of ethics, enacted by the local industry chamber to which the company is a member. However, it is important to highlight that those chambers are not a government agency and, thus, only its members must comply with its code and the rules under such codes of ethics are, inter alia, not regulations in force (i.e., any defense argument grounded on such internal codes could be dismissed by the health authority and courts).

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

The manufacturing of medicines and medical devices products are both regulated by ANMAT.

ANMAT Regulation No. 2,819/2004 -as amended and complemented by ANMAT Regulations No. 3,602/2018, 3,827/2018 and 1,281/2019, set forth the Guidelines for Good Manufacturing Practices for manufactures and importers/exporters of medicines -“GMP”.

The GMPs are applicable to manufacturing operations of medicines in all of its definitive pharmaceutical forms, including big-scale processes at hospitals and preparation of supplies for use at clinical trials. “Manufacturing/production” is defined as all the operations of acquiring materials and products, manufacturing, conditioning, quality control, release, warehousing, distribution of pharmaceutical products, and the controls related to it. “Manufacturer/Producer” is defined as the facility authorized to perform such operations (e.g., manufacturing, conditioning, and labeling of pharmaceutical products). The activities must be performed at a designated facility duly authorized and under the management of an authorized technical director. A quality control director should also be appointed to control and guarantee compliance. The guidelines of Good Manufacturing Practices and Good Quality Control Practices issued by the World Health Assembly (in May 1992) have been adopted in these regulations. Infringements of any of these obligations trigger the sanctions set forth in the Law on Medicines.

On the other hand, ANMAT Regulation No. 3,266/2013 provides the Good Manufacturing Practices for medical devices products.

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

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognize inspections of manufacturing sites for medicines conducted in their respective territories has progressed as planned, and it is now operational (with the exceptions of some products such as veterinarian products or products intended for use in clinical trials). The agreement aims to reduce duplicate inspections and allows the EU and FDA authorities to focus on manufacturing facilities outside the United States or Europe that are considered to be at higher risk. We consider that it may take a long time for the FDA and the EMA to recognize the inspections of Argentina plants, and in this sense, to recognize the GMPs requirements in Argentina as compatible with the FDA and EMA ones.

11. What is the inspection regime for manufacturing facilities?

ANMAT is allowed to make on-site inspections at any time, with or without prior notice, to inspect premises and verify compliance with the local regulatory framework. Good manufacturing practices, stability, and labeling standards and all other applicable provisions must be complied with. The legal inspection regime for medical device products is set forth in ANMAT Regulation No. 3,265/2013. On the other hand, the manufacturers of pharmaceutical products must comply with the GMPs set forth in ANMAT Regulation No. 2,819/2004, as amended.

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

The FDA and EMA are allowed to perform inspections in the local manufacturing facilities. In the case of the Mercosur, the State Parties may coordinate with the ANMAT to conduct a joint inspection if deemed necessary, according to ANMAT Regulation No. 3,264/2013 for pharmaceutical manufacturers and ANMAT Regulation No. 3,265/2013 for medical devices manufacturers.

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

Medicines must be stored in licensed premises with controlled environmental conditions, for them to maintain their properties. It is important to protect medicines from sun exposure, for example. If the deposit has windows, these must have some protection system (curtains, painted glass or to be covered with paper) to avoid the heat affecting the medicines directly.

The place must have a uniform temperature, less than 86° Fahrenheit, since above this temperature the expected effect of the drug could diminish. The storage place must not be damp. The place must not have leaks or filtrations, the floor’s grilles must be covered. Floors and shelves must be cleaned with damp rags to avoid dust.

The use of aerosols and sprays to disinfect or scent the air is prohibited. The presence of infestations like insects and rodents must be combatted. Gel products must be used and baits must be correctly identified. The presence of domestic animals (dogs, cats, birds) must be avoided, since they are a potential source of infestations (fleas, ticks, lice). Medicines must be ordered in shelves and never directly on the floor. A space between the last box and the back wall’s shelf must be left to ensure correct ventilation.

The deposit must have an absolutely separate space (it can be a box) where the medicines that are not fit for use must be kept. It must be specifically clarified with posters that say “DO NOT TOUCH, MEDICINE NOT FIT FOR USE”. In this place the expired medicines will be stored. It is forbidden to eat inside the deposit because the food leftovers can attract insects (cockroaches and ants) and rodents.

Furthermore, it is required to comply with the specific storage conditions that feature in the product’s prospect, approved by the healthcare authority. Lastly, the medical devices or products for diagnosis for use in vitro that have been expired or rejected must be identified and separated in a duly identified area.

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

Section 3 of the Executive Decree No. 150/1992 (as amended and complemented), provides that labels must state the laboratory’s name, laboratory’s domicile, the name of the Technical Director, the name of the product and the generic name of the drug in the same size and lettering style, the pharmaceutical form, the expiration date, how the drug should be stored and the conditions for sale, the sequence of manufacturing and the wording “drug approved by ANMAT, certificate number XXX”.

In the case of medical devices, the packaging and labels must also be approved by ANMAT before placing the product on the market. According to ANMAT Regulation No. 2,318/2002, labels must state the following information in the Spanish language: Instructions for use in packaging (in exceptional cases, this information may not be included in the products of classes I and II), information for the use of the medical device product per unit (in the product or in the container), complementary information for the specificity of the product, corporate name and address of the manufacturer and importer, information strictly necessary so that the user can identify the product and the content of the container, if the word “sterile” is the correct one to use, the batch number preceded by the word “batch” or the serial number, as appropriate, manufacturing date and expiration date or expiration date, the specific conditions of storage, conservation and/or product handling, specific instructions for operations and/or use of the product, any warning and/or precaution that must be adopted, registration number of the medical device product, etc.

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

The labeling and packaging can provide all the relevant information that the consumer may need to obtain the best use possible of the medicine or the medical device. They may include pictograms, icons, different colors and all those elements of design that help a better understanding of the information. They may also induce the user to consult with the physician and/or the pharmacist in the event of any doubt that arises from the use of the medication or medical device.

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

The label and packaging must not infringe the interests of public health and always be previously approved by ANMAT. It may not be disguised, misleading, indirect, subliminal, or unfair. Finally, it should not attribute to the product a therapeutic, nutritional, cosmetic, diagnostic, preventive quality, or of any other nature not expressly recognized or authorized by the ANMAT.

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

ANMAT Regulation No. 4,980/2005 establishes the general principles for the promotion of medicines sold over the counter to the general public and medical devices that can be directly used by patients and/or non-professional users, among other products such as food, cosmetics, etc. Under this regulation, the promotion must ensure a proper use of the product, objectively showing its properties, without misleading purposes, and must provide true, accurate, and clear information. The promotion may not infringe the interests of public health. It may not be disguised, misleading, indirect, subliminal, or unfair. Finally, it should not attribute to the product a therapeutic, nutritional, cosmetic, diagnostic, preventive quality, or one of any other nature not expressly recognized or authorized by ANMAT.

Any advertising of medicines or medical devices products must:

1. not advertise in a misleading, indirect, disloyal or subliminal way;
2. not use messages that provoke fear or distress;
3. not assign therapeutic and/or diagnostic (or of any nature) properties or actions that have not been expressly recognized or authorized by the health authority;
4. not advertise products that require a prior marketing authorization of the health authority without such authorization; and
5. make all the scientific information included in any advertising available to the health authority.

It is forbidden to promote medicines sold under prescription to the general public (Law on Medicines No. 16,463 as amended, Decree No. 9,763/1964, and MoH Regulation No. 627/2007). The promotion of medicines sold under prescription should only be addressed to healthcare professionals licensed to prescribe or dispense medicines (physicians and pharmacists), and carried out only by means of scientific publications or events, under the guidelines of MoH Regulation No. 627/2007.

Local regulations only allow the promotion to the general public of those registered medical devices that can be directly used by patients and/or non-professional users (Section 9 of ANMAT Regulation No. 4,980/2005). Pursuant to Annex I of Regulation No. 4,980/2005 and Section 1 of former Ministry of Health and Environment Regulation No. 20/2005, any advertising of medical devices products must:

• Not advertise in a misleading, indirect, disloyal or subliminal way.
• Not use messages that provoke fear or distress.
• Not assign therapeutic and/or diagnostic (or of any nature) properties or actions that have not been expressly recognized or authorized by the health authority.
• Not advertise products that require a prior marketing authorization of the health authority without such authorization.
• Make available to the health authority all the scientific information included in any advertising.

All advertising of medical devices that by their intrinsic nature and indications can be used directly -or indicated for their direct use- by a patient and/or not professional user, must:

• Seek the appropriate use of the product, describing its properties and characteristics without deception, providing accurate, truthful and clear information.
• Include the commercial name of the product.
• Include the wording “READ THE INSTRUCTIONS CAREFULLY. CONSULT YOUR DOCTOR IF YOU HAVE ANY DOUBTS” and comply with some specific rules, basically, for easy reading and comprehension by patients.
• Comparative advertising must not: (a) create confusion with the comparison; (b) belittle another product; (c) distort the image of another product; (d) undermine the name and/or reputation of third parties; (e) try to create a rejection situation towards the competitors’ products or its users.
• Unless being authorized by the relevant authority and depending on the risk of the product, only physicians, dentists, pharmacists, and authorized public government entities can dispense free samples to the general public.
• Advertising may include a telephone number or website for consultations, provided that the available information complies with the provisions of ANMAT Regulation No. 4,980/2005.
• The advertising through internet and any non-traditional advertising must comply with all the provisions of Annexes I and VII of ANMAT Regulation No. 4,980/2005.

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

Virtual drug distribution is not allowed in Argentina. The delivery of medicines to any domicile or any type of direct or indirect delivery of medicines to the general public or establishments not authorized for such purpose, including the sale via post office, electronic, telephone, internet or any other modality that can be considered different to the activities granted by the company’s registration, is expressly prohibited.

The delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies. The sale and delivery of such products in other places is deemed an illegal practice of pharmacy.

The commercialization chain of medical devices does not have a specific regulation, as it does with medicines. In this sense, medical devices can only be marketed by companies duly licensed and controlled by the health authority.

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

All the advertising made online for OTC medicines and medical device products that can be directly used by patients and/or non-professional users must comply with the provisions of ANMAT Regulation No. 4,980/2005.

In the case of prescription medicines, the promotion made through websites and/or in any other way over the Internet can only be addressed to healthcare professionals provided that the provisions set forth in MoH Regulation No. 627/2007 are fulfilled.

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

Medicines

Only the promotion of OTC medicines can be directly advertised to consumers provided that the requirements and conditions set forth in ANMAT Regulation No. 4,980/2005 are met. The promotion of medicines sold under prescription to the general public is forbidden.

Basically, any promotional activity of prescription medicines is subject to the following principles:

• The promotion of a medicine that has not obtained the corresponding MA, and the authorization for commercialization, is prohibited;
• All contents of the promotion of medicine must be adjusted to the identifying data approved in the MA (off-label promotion is forbidden); and
• The promotion of medicines must favor its rational use, presenting them objectively within the framework of their pharmaceutical properties, therapeutic sphere, and indications so approved (on label).

The technical-scientific information necessary for the healthcare professional recipient to know about the therapeutic properties of the medicine must be provided. It is mandatory for pharmaceutical companies to comply with MoH Regulation No. 627/2007, and to:

• Ensure that the promotion activities of prescription products adjust to the abovementioned dispositions;
• Verify that all medical advertising agents, sales reps and/or persons authorized by laboratories receive adequate information and training and comply with all the obligations established under this Regulation;
• Keep records on file for at least two years for each one of the promotional materials used and their bibliographic records that may be required by the health authority; and
• Provide to the health authority with the necessary information as requested.

The delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies.

Medical Devices

Local regulations only allow the promotion to the general public of those registered medical devices that can be directly used by patients and/or non-professional users. Advertising of medical devices must comply with the ethical criteria set forth by ANMAT.

The promotion and advertising of medical devices intended for professional use only is not yet regulated in Argentina (there is a legal gap). Therefore, which modes of advertising are expressly permitted when it comes to medical devices intended for professional use only cannot yet be specified.

However, under a reasonable interpretation of our local regulations, it could be construed that any promotional activity related to a medical device intended for professional use only and addressed to healthcare professionals should: (i) be made in compliance with the information contained in the MA granted by the local health authority; and also (ii) follow the rules contained in ANMAT Regulation No. 4,980/2005 as may be applicable for the healthcare professional recipient.

21. How is compliance monitored?

ANMAT uses an automatized system to control in real time any advertisement of medicines sold over the counter (among other products) directed to the general public.

Companies holding MA of medicines sold under prescription must notify ANMAT of the promotion related to such products (ex-post).

22. What are the potential penalties for noncompliance?

Any infringement to the Law on Medicines or its regulations would make the holder of the publicized product liable for the penalties provided by the Law on Medicines No. 16,463. Infringements to the Law on Medicines or its regulations can be punished with:

• Warnings.
• Fines from ARS 1,000 to ARS 1 million (Decree No. 341/1992 and ANMAT Regulation No. 1,710/2008).
• Total or partial, provisional or permanent closure of the premises where the infringement was committed, depending on the seriousness of the violation.
• Suspension or forfeiture of the business or professional license for a maximum of three years or, for extremely serious offences, permanent forfeiture of the license.
• Seizure of the infringing products.
• Forfeiture of the license for selling and manufacturing the products.

The statute of limitations for actions arising from the Law on Medicines is five years. This term is interrupted if another violation to the Law on Medicines or its complementary regulations is committed.

Any violation of Executive Decree No. 274/2019 (Fair-Trading Decree) will be punished with the following penalties:

• Warnings.
• Fines from ARS 40.61 to ARS 406,100,000 (updated every year).
• Suspension for up to five years from listing on the providers’ registers of those who can contract with the state.
• Loss of concessions, privileges, tax or credit benefits.
• Total closure of the premises for a maximum of thirty days.

Any infringement to the Law No. 24,240 (Consumer Protection Law) will be punished with the following penalties, jointly or independently:

• Warnings.
• Fines that can range from ARS 100 to ARS 5,000,000.
• Forfeiture of the products under infringement.
• Closure of the premises or suspension of the services for up to 30 days.
• Suspension for up to five years from listing on the providers’ registers of those who can contract with the state.
• Loss of concessions, privileges, tax or credit benefits.
• Publication of the sanction in a recognized newsletter of the place where the infringement took place.

Any infringement to the Law No. 17,565 (Law for the Pharmacy Practice), and/or its regulations may be punished with the following:

• Warning;
• Fines from ARS 1,000 to ARS 1 million (Decree No. 341/1992 and ANMAT Regulation No. 1,710/2008);
• Total or partial, provisional or permanent closure of the premises where the infringement was committed, depending on the seriousness of the violation involved or in case of recidivism;
• Suspension or forfeiture of the business or professional license during a maximum term of three years;
• Seizure of the infringing products; and/or
• Forfeiture of the license for selling and manufacturing the products.