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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The price charged by the company in foreign countries.

Authorisation anvisaa For a medicine to be registered, it must be proven, by means of scientific and analytical evidence, to be safe and effective for its intended use, and have sufficiently high quality, activity and purity for human use Article 16, Law No. The medicine’s brand name except for generics. Assurance of information concerning the methodology used before and during the trial, including the possibility of inclusion in a control or placebo group.

Medicinal product regulation and product liability in Brazil: overview

This law is regulated by Decree No. Pricing, state funding and reimbursement 4. To prove the interchangeability of generic medicines, ANVISA requires the submission of bioavailability and bioequivalence assays:. Restrictions on dealings with healthcare professionals Trade mark and patent rights can be used to oppose parallel imports.


Key stages and timing It takes roughly between six months to one year to:. This law was recently amended by Law No. The whole process generally takes from one to two anvsia, depending on the category of the medicine and on possible office actions that may be issued during ANVISA’s analysis. However, for some others activities, the authorisation must be renewed annually.

However, the material is provided in Portuguese only. Limitation periods There is a five-year limitation period for consumers bringing claims for damages caused by defective products.

For criminal complaints, the limitation period can be up to 20 years, anivsa on the maximum penalty applied to the crime ArticleCriminal Code.

Are there proposals for reform and when are they likely to come into force? Brazil, ; Registered Industrial Property Agent. Legislation and regulatory authority Law No.

Ministério da Saúde

Indications and contra-indications of the product. The potential number of patients to be treated with the product. It provides for, among other things, the production, commercialisation, advertising, labelling, inspection, quality control, penalties, importation and marketing approvals of medicines, drugs, pharmaceutical active ingredients, medical devices, cosmetics, household products and other products.

County rules must also be observed. An importer can have IP law enforced against it. Including images of people using the medicine. The price readjustment reached a maximum of 4.

The legislation is constantly updated, but is provided in Portuguese only. This includes monitoring the existence or lack of the necessary marketing authorisation. The Civil Code Law No. Although some decisions impose punitive damages, this is a controversial issue in Brazil. Legislation and regulatory authorities Clinical trials are regulated by the National Anviss Council, linked to the Ministry of Health, through Resolution No.


Forms of reimbursement of current expenditure resulting from participation in the trial. Two constitutional clauses establish the foundation for the framework:. Information requirements The packaging of medicinal products must contain certain minimum information, including:.

It is currently regulated by Ordinance No. Publish the abvisa and licence in the Official Gazette. The following must be included:. The rules governing pharmacovigilance on medicinal products for human use are set out in Resolution No. Authorising the operations of companies manufacturing, distributing and importing medicines.

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

The telephone number of the customer service of the marketing approval holder. Further, it is not possible to distribute free samples of medicines that are not registered at ANVISA, as well as non-commercialised presentations xcb medicines.

Brazilian Bar Association,