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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Internet advertising Advertising prescription medicines over the internet is prohibited, unless the advertisement is only accessible by professionals who are authorised to prescribe or dispense medicines Resolution No.

Closing down, as a sanitary surveillance measure, manufacturing plants and any premises involved in the management, importation, storage, distribution and sale of health-related products and services, if the relevant legislation is violated, or if they constitute a likely health risk.

Under the Criminal Code, the following are potentially liable for defective pharmaceutical products ArticleCriminal Code:. Authorising the operations of companies manufacturing, distributing and importing medicines. Anivsa ports, airports and borders and co-ordinating the National System of Sanitary Surveillance. Procedural requirements The sponsor must file annual reports about the trial, and a final report with the conclusion of the trial along with a special report concerning adverse reactions.

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

ANVISA, as well as the state and municipal bodies, are also responsible for imposing administrative penalties for any statutory sanitary infringement, after administrative prosecution. It is linked to the Ministry of Health, but operates as a financially autonomous regulatory agency.

Analysing patent applications related to pharmaceutical products and processes, ccb with the Brazilian Patent and Trademark Office BPTO Instituto Nacional da Propriedade Industrial prior consent analysisaccording to the updated proceedings set out in Resolution No. Other conditions There are also specific requirements for prescription medicines, and specific warnings regarding children, free samples and routes of administration. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?


The cost per patient of treatment with the product. This includes monitoring the existence or lack of the necessary marketing authorisation.


In the latter case, the device will need to comply with Resolution No. What is the authorisation process for manufacturing medicinal products? The Brazilian population therefore has the right to receive free medicines. However, data package exclusivity for pharmaceutical products for human use is rather controversial.

Medicinal product regulation and product liability in Brazil: overview

What is the structure of the national healthcare system, and how is it funded? 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. Funds are transferred from the National Health Insurance Fund to the other regional governments.

A comparator product must be elected. ANVISA’s resolutions set out the specific and technical requirements for obtaining marketing approvals for:. Branded drugs similar medicines Resolution No. Biological products that require special care for maintenance and transport.

Any post-approval changes involving alterations, inclusions or cancellations must follow the procedures specified in Resolution No. Without active ingredients or with insufficient active ingredients.

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. Are foreign marketing authorisations recognised in your jurisdiction? How is the pharmacist compensated for his dispensing services?

However, the advertisement and indirect sale or the granting, offer, promise or distribution of promotional gifts, benefits and advantages dfb professionals are prohibited Resolution No.

Types of indemnity to cover possible injury resulting from the trial. What is the authorisation process for marketing medicinal products? Packaging and labelling Once this authorisation is granted, the company must obtain a licence from the local sanitary surveillance body state, county or municipalitieswhich ultimately allows the company to start its manufacturing activities.

Two other pieces of legislation are also relevant:. The defect or damage is exclusively attributable to the consumer’s fault.


Brazil, ; Registered Industrial Dcn Agent. Anyone who falsifies, corrupts, adulterates or alters a product intended for therapeutic or medicinal use.

Name and registration number in the Pharmaceutical Council of the pharmacist in attendance. Any foreseeable risks or discomfort to the subject, as well as benefits that might reasonably be expected, associated with participation in the trial.

Information requirements The packaging of medicinal products must contain certain minimum information, including:. The possibility to request designation as a rare disease drug. Trial subjects must give their informed ahvisa to the following:.

IP laws prohibit parallel imports into Brazil. In addition, all medical devices, regardless of the class must comply with principles of safety and ddcb, as provided by Resolution No. The applicant must use comparability in terms of quality, safety and efficacy between the comparator biological product and the biological product.

However, pharmacist technicians must be under direct supervision of a registered pharmacist technically responsible or a substitute also a pharmacistwhose presence is required during opening hours of the commercial establishment.

An importer can have IP law enforced against it. Information regarding the medicine’s formula and composition, including weight and qnvisa.

The price charged by the company in foreign countries. When there is sufficient evidence or confirmation of non-compliance posing a health risk, dxb if a marketing authorisation has been cancelled due to safety and efficacy issues, Resolution No. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and competition law in Brazil: A specific provision allows for the postponement of those deadlines once, for one third of the statutory limit, under strict conditions.

The SNCM is currently working on a trial basis with selected products, anivsa is expected to be fully implemented by April