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 company must also obtain approval from the state sanitary surveillance body for the building’s projects and plants. Non-compliance with sanitary rules incurs snvisa under Law No.

However, the material is provided in Portuguese only. In anvksa case of imported medicines and active pharmaceutical ingredients, in addition to the usual registration requirements, the company must also prove that the product is already registered in the country of origin Article 18, Law No. IP laws prohibit parallel imports into Brazil. When available, the results of phase IV studies should be submitted. Under the Civil Code, any person who violates a right or causes damage to another, voluntarily or by omission, negligence, recklessness or malpractice, must make reparations for such damage.

This enshrines the government’s duty anvias regulate the provision of health services and products, whether directly or through third parties, and provides for the Brazilian regulatory framework for pharmaceutical products, medical devices and pharmaceutical active ingredients. amvisa


What is the authorisation process for marketing medicinal products? The whole process generally takes from one to two years, depending on the category of the medicine and on possible office actions that may anvisz issued during ANVISA’s analysis. Pharmaceutical industries qnvisa have a role in the pharmacovigilance system, informing ANVISA of any problems with medicines.


Under the Criminal Code, the following are potentially liable for defective pharmaceutical products ArticleCriminal Code:. Other conditions There are also specific requirements for prescription medicines, and specific warnings regarding children, free samples and routes of administration.

This resolution brings Dxb standards in line with international guidelines and aims to encourage the development of clinical trials in Brazil, besides promoting Brazilian participation in clinical trials carried out simultaneously in different countries.

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

The cdb must submit full data regarding quality issues but this does not have to be comparative. Medicines prepared by compounding pharmacies. Drugs subject to special control Ordinance No. If medicines are not marketed within a certain period, marketing approval cannot be renewed. Do data protection laws impact on pharmaceutical regulation in your jurisdiction? Controlling ports, airports and borders and co-ordinating the National System of Sanitary Surveillance.

The commercialisation plan, including advertising and sales costs. All federal laws and presidential decrees currently in force are available on this website.

Advertising prescription medicines over the internet is prohibited, unless the advertisement is only accessible by professionals who can prescribe or dispense medicines see Question 16, Internet advertising.

Approving the import and export of medicines, granting marketing approval for medicines and granting and cancelling GxP certificates. Although some decisions impose punitive damages, this is a controversial issue in Brazil. Concentration, dosage form, xnvisa of administration, strength, and therapeutic, preventive or diagnostic indication.

Name and registration number in the Pharmaceutical Council of the pharmacist in attendance. Are punitive damages allowed for product liability claims? The distribution of medicines subject to special control is subject to stricter rules Ordinance No. Prove its navisa, scientific and operational capability.

Under this system, labels can include a code snvisa identifies the medicine and its registration information. The prices of new medicinal products and new presentations of medicines are strictly regulated in Brazil.


What are anviisa restrictions on selling medicinal products? Article of the FC In other words, the registration holder will need to provide evidence that its drug has been commercialised for the last 40 months before the marketing approval expiration. Suggesting or encouraging diagnosis by the general public. It is doubtful whether it will be adopted into law. This provides for post-registration changes and inclusions, suspensions and reactivations of manufacture and cancellation of registration of biological products.

Ministério da Saúde

This measure does not prevent judges from considering urgent cases. Conditions To obtain an operating authorisation and licence, a company must Articles 2, 50, 51 and 52, Law No. The storage conditions, indicating the temperature range and storage conditions indicated by the medicine’s stability study. Authorisations Every clinical trial to be anviss with medicinal and health products in Brazil, regardless of its subject for example, whether new medicines or new or therapeutic indicationsmust be submitted to ANVISA’s prior evaluation by means of a clinical development dossier.

Among other things, advertisements must state the:. All the information that does not fit in the external packaging must be contained in the insert packaging. The Supreme Ecb 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.

There is no direct or indirect reimbursement to end users or pharmacists in Brazil. Restrictions on dealings with healthcare professionals