ANVISA Resolution – RDC n. 17, of April 16th I – Internal code name as a reference and DCB, if any; DCB), with the amount used of each one, using the. ANVISA. BRAZILIAN HEALTH REGULATORY AGENCY. Brazilian . List of Brazilian Non proprietary Names (DCB). documento emitido pela Anvisa atestando que determinado esta- belecimento IX – Denominação Comum Brasileira (DCB) – nomenclatura.

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Medicinal product regulation and product liability in Brazil: overview | Practical Law

Restrictions on foreign applicants Foreign manufacturers can market medicinal products in Brazil as imported goods, through local subsidiaries or local commercial representatives. Trade mark and patent rights can be used to oppose parallel imports. Indications and contra-indications of the product.

IP laws prohibit parallel imports into Brazil. Decentralisation, with a single management in each sphere of government.

Medicinal product regulation and product liability in Brazil: overview

The distribution of medicines subject to special control is subject to stricter rules Ordinance No. Although the Constitution establishes that health is everyone’s right, the Brazilian public health care system is anviza used by citizens who cannot afford private health care.

There are no particular rules referring to marketing medicinal products by mail order.

A common practice used to avoid the advertising rules is to partner with medical societies to campaign for awareness and prevention of diseases, without specifically mentioning products. The rules governing pharmacovigilance on medicinal products for human use are set out in Resolution No.

The Supreme Federal Court STF is currently assessing two appeals, recognised as matters of general application, focusing on the economic burden of such treatments and whether the government could be ordered to provided medicines not approved by ANVISA.


The defect or damage navisa exclusively attributable to the consumer’s fault. The name of the manufacturer and place where the medicine is manufactured country, state and city, in the case of imported products. It is currently regulated by Ordinance No.

If medicines are not marketed within a certain period, marketing approval cannot be renewed. What is the structure of the national healthcare ahvisa, and how is it funded?

Advertising a drug as being new, if it has been on the market for more than two years except for new therapeutic indications. CMED is responsible for monitoring and regulating the pharmaceutical market and establishing parameters and criteria for setting and adjusting the prices of medicines in Brazil, to stimulate competition in the market. Regulatory authorities Law No. Care provided under SUS is split between the public and private sectors. Are there any mandatory requirements relating to medicinal product safety?

The SNCM is currently working on a trial basis with selected products, and is expected to be fully implemented by April A similar medicine can only differ in characteristics related to size and form of the product, expiry date, packaging, labelling, excipients and vehicles, and must always be identified by its trade mark. Advertisements, visits by representatives, distribution of free drug samples or other gifts and sponsoring of meetings and seminars are all permitted, provided that these interactions do not influence a medical practitioners’ prescription decisions inappropriately.

When is the cost of a medicinal product funded by the state or reimbursed? What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? It is linked to the Ministry of Health, but operates as a financially autonomous regulatory agency. The Civil Code section 21 and the Federal Constitution Article 5, item X grant privacy rights, under which everyone has the right to keep secret certain information concerning their personal lives, including aspects of their own health.


Funds are transferred from the National Health Insurance Fund to the other regional governments. Suggesting or encouraging diagnosis by the general public. Generic medicines Resolution No. Succeeded in two lawsuits representing a major Brazilian jeweller unduly accused of copyright infringement.

Combination products are not subject to a specific regulation. Any foreseeable risks or discomfort to the subject, as well as benefits that might reasonably be expected, associated with participation in the trial. Biological products Resolutions No. Pricing, state funding and reimbursement 4.

Among other issues of relevance, Resolution No. Are there further conditions concerning how the drug is distributed and accessible to patients? Pharmaceutical industries also have a role in the pharmacovigilance system, informing ANVISA of any problems with medicines. The distribution of institutional gifts, that is, gifts that do not advertise medicines, and of scientific papers, magazines or publications and technical books used for professional updates, are allowed Normative Instruction No.

Dxb product has not been placed on the market. Restrictions on dealings with healthcare professionals Are there proposals for reform and when are they likely to come into force?

What are the restrictions on selling medicinal products? Conditions To obtain an operating authorisation and licence, a company must Articles 2, 50, 51 and 52, Law No. Brazil, ; Registered Industrial Property Agent.

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