June 22, 2019

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.

Author: Mezilmaran Meshicage
Country: Algeria
Language: English (Spanish)
Genre: Marketing
Published (Last): 16 August 2014
Pages: 194
PDF File Size: 4.60 Mb
ePub File Size: 8.50 Mb
ISBN: 277-2-97450-524-9
Downloads: 34705
Price: Free* [*Free Regsitration Required]
Uploader: Mosho

Authorising the operations of companies manufacturing, distributing and importing medicines. This situation is considered in many cases a conflict of interest and may be relevant, as many health care professionals simultaneously hold positions in public service and work in private practice. Sales and marketing The local subsidiaries or local commercial representatives must obtain an operating authorisation and licence, as well as marketing authorisation for each imported product.

Ministério da Saúde

The website is updated frequently, but most materials are only available in Portuguese. This underpins ccb constitutional right and the government’s duty to implement health policies aimed at reducing the risk of illness and other hazards for the whole population, as well as to provide equal and universal access to programmes and services to promote, protect and recover health. At least one comparative phase III study equivalence, superiority or non-inferiority with the originator anisa product is mandatory except for hemoderivatives, vaccines and biological products for oncological use.

With correct ingredients but fake packaging. 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.


Medicinal product regulation and product liability in Brazil: What is the authorisation process for marketing medicinal products? File the operating licence request at the local sanitary surveillance body.


What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction? 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: The commercialisation plan, including advertising and sales costs.

The applicant must use comparability in terms of quality, safety and efficacy between the comparator biological product and the biological product.

Trial pre-conditions Insurance coverage is not required, but the sponsor must declare itself responsible for assistance in the case of complications or damage caused during the trial, including adverse reactions. The packaging of these samples must contain the non-removable terms “free sample”. Period of authorisation and renewals The operating authorisation is valid indefinitely for local manufacturers. Prove its technical, scientific and operational capability. Assurance of information concerning the methodology used before and during the trial, including the possibility of inclusion in a control or placebo group.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and competition anvida in Brazil: Specify its industrial activities and the kind of products it wishes to manufacture. Succeeded in two lawsuits representing a major Brazilian jeweller unduly accused of copyright infringement.


Authorisation conditions 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.

A comparator product must be elected. In Maythe Superior Court of Justice STJ suspended all lawsuits in progress and highlighted the obligation of the state to provide high and low costs medicines not avnisa through the SUS.

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

Anyone who commits these actions with products that:. Controlling ports, airports and borders and co-ordinating the National System of Sanitary Surveillance. The applicant must submit full data regarding quality issues but this does not have to be comparative.

The claimant can file a civil lawsuit claiming individual damages civil liability. This provides for procedures and conditions for conducting stability studies for registration or post-registration changes of biological products. Who is potentially dccb for defective medicinal products?

Restrictions Under Law No. Article of the FC Recordal of such devices need not be renewed. Extent to which confidentiality of records will be maintained, to safeguard the privacy of the research subjects.