Marketing, Manufacturing, Packaging & Labeling, Advertising
Trench Rossi e Watanabe / Brazil
Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The company should be licensed before ANVISA (at the federal level) and before the local health authority (at the local level). The company must be also assisted by a technical responsible. Finally, the product must be licensed before ANVISA and the company must obtain GMP certificate (depending on the type of product). After being duly licensed before the health authorities, the company must apply for the product registration (the request must be attached to the product’s dossier, which contains detailed information about the overall development of the product, including efficacy and safety data, chemistry, manufacturing and controls information and clinical trials). ANVISA will then review the information provided about the products and, if the analysis is positive, ANVISA will publish the issuance of the marketing authorization in the Official Gazette.
2. What is the authorization process for the marketing of generic versions of these products?
The process is the same.
3. What are the typical fees for marketing approval?
There fees related to product’s marketing authorization will depend on the product and on company’s corporate size (e.g. for new drugs the fee may vary from BRL 15,741.00 – approx. US$ 2,625.00 – up to BRL 157,416.00 – approx. US$ 26,236.00).
4. What is the period of authorization and the renewal process?
Company’s licenses before ANVISA do not expire.
Drugs’ marketing authorization is valid for 10 years and the renewal must be requested from 12 up to 6 months before product’s marketing authorization expires. Medical devices’ marketing authorization is valid for 10 years.
The GMP certificate is valid for 2 years.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Pharmacovigilance is a duty of the marketing authorization holder, which must comply with specific notification timings, depending on the type of issue, and must define measures and policies for identifying, evaluating and monitoring the occurrence of adverse events and other issues related to the commercialized drugs. The marketing authorization holder is also responsible before ANVISA for recall measures.
6. Are foreign marketing authorizations recognized?
No.
7. Are parallel imports of medicines or devices allowed?
No. Only the marketing authorization holder or a duly licensed legal entity properly authorized by the marketing authorization holder may import a drug or a medical device.
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?
Such practices are mainly ruled by ANVISA’s Resolution No. 96/2008 (in the event of drugs) and by industry association codes.
ANVISA Resolution RDC 96/08, article 5, provides that pharmaceutical companies cannot offer gifts, benefits or anything else of value to physicians who can prescribe medicines, whether or not the intent was quid pro quo. However, low-value gifts (pens, notebooks, etc.) are still authorized. Prescription pads cannot contain the company logo or promote a drug. Materials containing scientific information such as magazines and medical journals can be freely distributed.
The industry codes of conduct and the physicians’ professional councils impose additional restrictions on marketing activities and that anti-corruption laws also apply to public practice physicians.
Among industry codes, it is worth mentioning that the INTERFARMA (Pharmaceutical Research Association) code of conduct prohibits granting gifts offering gifts/benefits (i) of prescription drug; (ii) of a personal-use nature, including (but not limited to) electronic devices and/or tickets to concerts, theater, performances and sporting events; (iii) in cash and/or equivalent, including (but not limited to) credit cards, gift certificates and/or gift vouchers; (iv) of subscriptions to print and online magazines, even if they possess scientific contents; (v) used in the routine management of a medical office, including (but not limited to) pens, pencil-holders, and notepads.
The ABIMED (Brazilian Association of Industry of High Technology Medical and Hospital Equipment, Products and Suppliers) code of conduct provides that it is allowed to grant gifts that have an educational value, provided that such gifts (i) are related to the training of how to use certain product; (ii) are of low amount; and (iii) are related to the medical practice or provide benefits to a patient. Except for scientific books and anatomic models, the limit on gift amount is BRL 100 (approx. US$ 27.00).
Note that such Codes of Conduct are mandatory to the affiliated companies.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of drugs and of devices is regulated by ANVISA, that authorizes the operation of the companies, issues resolutions related to good manufacturing practices, and performs inspections on company’s premises and 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?
Yes, we consider that local requirements are compatible. ANVISA’s rules are influenced by North American and European rules.
11. What is the inspection regime for manufacturing facilities?
ANVISA and local health authorities have powers to perform inspections at any time in order to monitor company’s (i) regular licensing; and (ii) compliance with good manufacturing practices. Note that the authorities will always inspect companies’ premises when companies apply for the sanitary licenses or for the good manufacturing practices certification.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The activities of storage, packing and handling of drugs are ruled by different federal and local rules. The type of drug may also influence the legal requirements. An evaluation on a case by case basis is necessary. As a rule, the storage must comply with the requirements established by product’s manufacturer. Regarding the label, Resolution RDC No. 71/2009, which rules labeling and packaging of drugs, provides that drugs’ packages must indicate: (i) commercial name of the drug; (ii) the generic name of each active principle; (iii) the concentration of each active principle; (iv) route of administration; (v) weight, volume or units; (vi) total quantity of dispensing accessories, where applicable; (vii) pharmaceutical form; (viii) use restriction by age group; (ix) qualitative and quantitative composition of each active principle; (x) conservation care; (xi) name, address and Taxpayer number of the marketing authorization holder ; (xii) name and address of the manufacturing company, when the drug is imported; (xiv) name and address of the company responsible for the packaging; (xiii) name and number of enrolment before the Professional Council of marketing authorization holder’s technical responsible; (xiv) phone number of the Customer Service; and, (xv) Number of the registration before ANVISA.
14. What information must be included in medicine and device labeling?
The requirements will vary depending on the type of product. However, in general, labels must contain information about importer’s and manufacturer’s corporate name and address, product’s commercial name, active ingredient, use instructions, warnings, batch, validity term, storage conditions, name of the technical responsible, number of registrations before ANVISA and customer service contact information.
15. What additional information may be included in labeling and packaging?
The requirements will depend on the type of the product.
16. What items may not be included in labeling and packaging?
The requirements will depend on the type of the product. Note, however, that labels must not contain false or misleading information.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Some of the restrictions on the advertising of drugs are:
- The company which is promoting the advertisement must be duly licensed before the health authorities (Article 3º, §1º of Resolution RDC No. 96/2008);
- The drug which is being advertised must be duly registered before ANVISA (Article 3º of Resolution RDC No. 96/2008);
- The company must not promote an off-label use or an unregistered device (Article 3º, §2º of Resolution RDC No. 96/2008);
- Product’s registration numbers before ANVISA must be indicated in the advertisement materials (Article 22 of Resolution RDC No. 96/2008);
- All clinical and therapeutic claims in advertising material related to the drug must be based on substantiated scientific data having clinical and statistical significance (Article 7 of Resolution RDC No. 96/2008);
- Information inserted in advertisement material must be coherent with the information provided to ANVISA and with duly published and approved technical literature and scientific papers, as well as in accordance with regulation and legal requirements (Article 3º, §2º of Resolution RDC No. 96/2008);
- All advertising material must be truthful and non-misleading, coherent and consistent with the visual, artistic, and copy plan (Article 14 of Resolution RDC No. 96/2008);
- Under prescription drugs could be promoted only to physicians and pharmacists (“HCPs”) (Article 27 of Resolution RDC No. 96/2008);
- Adverting of OTCs must contain warning messages, advertisement of OTCs must contain warning messages (Article 22 of Resolution RDC No. 96/2008);
- Companies are not allowed to provide, offer, promise or distribute small gifts, benefits or advantages to prescribing or dispensing HCPs and to the general public. There are exceptions, such as institutional small gifts (which do not advertise drugs), scientific materials, such as technical books and educational materials for professional update (Article 5º of Resolution RDC No. 96/2008).
Advertising of drugs for the consumers are allowed only for OTC drugs and if the drug is registered before ANVISA and by a duly licensed company.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Only pharmacies and drugstores can commercialize drugs for the consumers and these companies can delivery the product by remote means, such as telephone and internet, provided that the restrictions defined in the legislation are met. Note however that the delivery should only be made by the pharmacies’ or drugstores’ currier and not by Brazilian Post, since the Brazilian Post has no pharmaceutical responsible to supervise the activity.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by the Internet, social media, and other channels?
For drugs under prescription, the advertising must be made only to the prescribing or dispensing HCPs. It must also contain a liability statement should be presented informing about the legal access restriction. OTC drugs can be advertised through electronic means, provided that requirements are observed. Some of these requirements are:
- The company must not promote an off-label use or an unregistered device (Article 3º, §2º of Resolution RDC No. 96/2008);
- Product’s registration numbers before ANVISA must be indicated in the advertisement materials (Article 22 of Resolution RDC No. 96/2008);
- The clinical and therapeutic claims in advertising material related to the drug are based on substantiated scientific data having clinical and statistical significance (Article 7 of Resolution RDC No. 96/2008);
- Information inserted in advertisement material are coherent with the information provided to ANVISA and with duly published and approved technical literature and scientific papers, as well as in accordance with regulation and legal requirements (Article 3º, §2º of Resolution RDC No. 96/2008);
- All advertising material are truthful and non-misleading, coherent and consistent with the visual, artistic, and copy plan (Article 14 of Resolution RDC No. 96/2008);
- The advertisement includes the warning messages required (Article 22 of Resolution RDC No. 96/2008).
Note, however, that the current rules do not provide for advertising via email and social media.
20. May medicines and devices be advertised or sold directly to consumers?
No. Drugs and devices should only be commercialized to consumers by pharmacies and drugstores and advertisements are allowed only for OTC drugs.
21. How is compliance monitored?
At the federal level (by ANVISA) and at the local level (by the local health authorities). In both cases it could be through inspections, spontaneously initiated by such authorities or after anonymous tips from consumers or competitors.
22. What are the potential penalties for noncompliance?
Warning, fines (varying from BRL 2,000.00 – approx. USD 330.00; up to BRL 1,500,000.00 – approx. USD 250,000.00), seizure and disposal of the product, shut down of facilities, cancellation of sanitary licenses, prohibition of advertising, suspension of sale, imposition of rectifying message and/or the suspension of advertising.
