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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This sets out the penalties for infringing sanitary federal statutes and corresponding regulations, including criminal sanctions. Under this system, the federal government buys medicines from the industry and distributes or sells them to patients at a lower cost, through dch network of pharmacies.

Monitoring compliance and imposing penalties ANVISA, as well as the state and municipal bodies, are responsible for monitoring and enforcing compliance with food and drug laws.

Regulatory authorities Law No.


The storage conditions, indicating the temperature range and storage conditions indicated by the medicine’s stability study. This law is regulated by Decree Rcb. A reduced dossier can be submitted. What is the structure of the national healthcare system, and how is it funded? Brazil, ; Registered Industrial Property Agent.

The name and registration number of the pharmacist responsible for the medicine.

Trade mark and patent rights can be used to oppose parallel imports. Care provided under SUS qnvisa split between the public and private sectors. The price charged by the company in foreign countries. Publish the authorisation and licence in the Official Gazette.

Scb are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners? Combination products are not subject to a specific regulation.


Filing the application and additional documentation. In relation to the states, Federal District and municipalities, by their anviisa health offices. HTA is a continuous process of analysing and summarising the potential health benefits and the economic and social consequences inherent in employing certain technologies, while considering the following aspects: Period of authorisation and renewals The operating authorisation is valid indefinitely for local manufacturers.

This situation is considered in many cases a conflict of interest and may be relevant, as many health dch professionals simultaneously hold positions in public service and work in private practice. This is the Brazilian Presidency’s website.

Article 6, clause D of Law No. The supplier with the lowest price who proves that the medicine meets the legal and technical requirements of the procurement wins the bid.

Medicinal product regulation and product liability in Brazil: Legal provisions Liability for defective medicinal products can arise under:. However, recent court decisions covering medicinal product liability include:. The defect or damage is exclusively attributable to the consumer’s fault. ANVISA’s resolutions set out the specific and technical requirements for obtaining marketing approvals for:.

Conditions To obtain an operating authorisation and licence, a company must Articles 2, 50, 51 and 52, Law No. The number of non-clinical and clinical studies submitted can be reduced, depending on how much data is available on the pharmacological properties, safety and efficacy of the originator product. There is no direct or indirect reimbursement to end users or pharmacists in Brazil.

Authorising the operations of companies manufacturing, distributing and importing medicines.

Ministério da Saúde

Drugs subject to special control Ordinance No. Conditions and znvisa Similar medicines. The telephone number of the customer service of the marketing approval holder. For similar biological products, the following two regulatory pathways were introduced:. The distribution of medicines subject to special control is subject to stricter rules Ordinance No.


In the latter case, the device will need to comply with Resolution No. In addition, the company providing the service must provide a direct and immediate method of communication between the patient and a pharmacist.

Marketing Authorisation anvia abridged procedure.

Outline the regulation of clinical trials. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and competition law in Brazil: Information requirements The packaging of medicinal products must contain certain minimum information, including:.

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

CONAR’s objective is to eliminate advertisements and campaigns with misleading, offensive and abusive content, or which could, among other things, distort competition. Dxb possibility to request designation as a rare disease drug. What information can the applicant rely on? 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.

Suggesting or encouraging diagnosis by the general public. The price that the company intends to charge in the market, including tax. 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.