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 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?
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 (ANMAT Regulation No. 5,358/12). Likewise, pharmaceutical companies must appoint a professional within its company who assumes connection functions with the health authority (through its Pharmacovigilance Department) in order to exchange information regarding adverse effects on medicines marketed by such pharmaceutical company (basically, MoH Resolution No. 706/93, ANMAT Regulations No. 3,870/90 and 2438/00, ANMAT’s Circular No. 008/09 -which adopted the Pharmacovigilance Good Practices Guidelines, later complemented by ANMAT Regulation No. 5,358/12 setting-up the current Pharmacovigilance Good Practices-).
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 for more detail). Any product to be marketed in Argentina needs to previously obtain the relevant marketing authorization 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 before 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.
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?
Regulation 627/07, which implements Law 16,463, regulates the relationship between pharmaceutical companies and Healthcare Professionals (HCPs) providing ethical standards and guidelines to 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 motivated on non-ethical incentives instead of being a consequence of a professional decision based on scientific evidence. This regulation was enacted with the aim of tackling promotional practices that foster commercial circuits which jeopardize good practices for prescribing and that affect the rational use of drugs.
Promotional activities for prescription drugs are subject to the following principles:
- the promotion of a medicine which has not obtained the corresponding marketing authorization certificate is forbidden;
- all the contents of the promotion of medicines are adjusted to the characteristic identifying data appearing in the certificate of registration; and
- in any case, the promotion of medicines must favor 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 (Section 3 of Regulation 627/07).
Scope of Regulation 627/07 is applicable to the:
- promotion of medicines sold under prescription addressed to professionals licensed to prescribe or dispense medication;
- promotional visits by reps, medical promotional agents or persons authorized by pharmaceutical companies, addressed to professionals licensed to prescribe or dispense medicines;
- supply of free samples, samples for professionals, samples without commercial value or similar samples;
- sponsorship of promotional meetings where professionals licensed to prescribe or dispense medicines attend;
- sponsorship of scientific conferences where professionals licensed to prescribe or dispense medicines participate;
- 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
- promotion, offer, commercialization of medicines made through web pages and/or electronic mails and/or in any other way over the Internet.
Regulation 627/07 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 applied for scholarships. Thus, in order 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 taken into care when drafting internal policies.
Regulation 627/07 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 Regulation 627/07 are applicable for any event.
In regards 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 in regards to the relationship between medical devices’ companies and healthcare professionals; 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 industries rely its common practices in rules contained in its applicable code of ethics enacted by the local industry chamber in which the company is 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. it could be dismissed by the health authority any defense argument grounded on such internal codes).
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 Regulation No.3,602/18, 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 process at hospitals and preparation of supplies for using at clinical trials. “Manufacturing/production” is defined as all the operations of transforming materials and products, production, quality control, release, warehousing, transport and distribution of pharmaceutical products, and the controls related to it. “Manufacturer/Producer” is defined as the establishment which performs such operations, such as production, conditioning, re-conditioning, labeling and re-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 this regulation. Infringements of any of these obligations trigger the sanctions set forth in the Law on Medicines.
On the other hand, ANMAT Regulation No. 3,266/13 provides the Good Manufacturing Practices of 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 is progressing as planned. The agreement aims to reduce duplicate inspections, and will allow 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. 3265/13. On the other hand, the manufacturers of pharmaceutical products must comply with the GMPs set forth in ANMAT Regulation No. 2819/04, 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. 5,363/10 for pharmaceutical manufacturers and ANMAT Regulation No. 5,625/13 for medical devices manufacturers.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The medicine must be storage in licensed premises with controlled environmental conditions, for it to maintain its 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 grills must be covered. Floors and shelves must be cleaned with damp rags in order 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.
As for the storage of medical devices, there must be compliance with the specific storage conditions that feature in the product’s prospect, approved by the Healthcare Authority and, lastly, the medical devices or products for diagnosis for use in vitro that have been expired or rejected must be identified and separated in duly identified area.
14. What information must be included in medicine and device labeling?
Section 3 of the Executive Decree No. 150/92 (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. 2,318/02, labels must state the following information in the Spanish language: Instructions for use in packaging (may not be included in the products of classes I and II), information for the use of the medical product per unit (in container), incorporate 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 contents 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 (before the which should use the medical product to have full security), the specific conditions of storage, conservation and/or product handling, specific instructions for operations and/or use of the product doctor, any warning and/or precaution that must be adopted, registration number of the medical 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 in order 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, 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 the ANMAT.
Any advertising of medicines or 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; and
- 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. 9,763/64, MoH Regulation 627/07).
The promotion of prescription products 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 Regulation No. 627/07.
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. 4,980/05). Pursuant to Annex I of Regulation No. 4,980/05 and Section 1 of former Ministry of Health and Environment Regulation No. 20/05, 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 Regulation No. 4,980/05.
- The advertising through internet and any non-traditional advertising must comply with all the provisions of Annexes I and VII of Regulation No. 4,980/05.
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 (mainly, in accordance with Decree 1,299/97). 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 must comply with the provisions of ANMAT Regulation No. 4,980/05.
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 627/07 are fulfilled.
All the advertising made online for medical devices must comply with the provisions of ANMAT Regulation No. 4,980/05.
20. May medicines and devices be advertised or sold directly to consumers?
Only the promotion of OTC medicines can be directly advertised to consumers provided that the requirements and conditions set forth in ANMAT Regulation No. 4,980/05 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 marketing authorization certificate, and the authorization for commercialization, is prohibited;
- All contents of the promotion of medicine must be adjusted to the identifying data approved in the marketing authorization certificate (off-label promotion, it 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 Regulation No. 627/07, and to:
- Ensure that the promotion activities of prescription products adjust to the above-mentioned 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 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.
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.
In regards 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, 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 marketing authorization certificate granted by the local health authority; and also (ii) follow the rules contained in Regulation No. 4,980/05 as may be applicable for the healthcare professional recipient.
21. How is compliance monitored?
ANMAT Regulation No. 9,660/16 set forth that ANMAT will use an automatized system to control in real time any advertisement of medicines sold over the counter (among other products) directed to the general public.
As from September 2015, ANMAT Regulation No. 6,516/15 requires that companies holding marketing authorization certificates of medicines sold under prescription must notify ANMAT of the promotion related to such products.
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:
- Fines from AR$ 1,000 to AR$ 1 million (Decree No. 341/92 and ANMAT Regulation No. 1710/08).
- 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 Law No. 22,802 (Fair-Trading Law) and its complementary regulations will be sanctioned with a fine that can range from AR$ 100 to AR$ 500,000. For recidivism, the penalty will be increased. For serious infringements, seizure of the infringing goods can be ordered (sections 18 and 19, Fair-Trading Law).
Any infringement to the Law No. 24,240 (Consumer Protection Law) will be punished with the following penalties, jointly or independently (section 47, Consumer Protection Law):
- Fines that can range from AR$ 100 to AR$ 5 million.
- 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.
For the penalties for non-compliance with Law No. 17,565 for the Pharmacy Practice and MoH No. 1,644/08, as amended and complemented please see Question 3 in Preclinical and Clinical Trial Requirements.