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 commercialisation anvisx, including advertising and sales costs. The Public Prosecutor’s Office is responsible for bringing criminal lawsuits and public civil suits for collective damages.

Medicinal product regulation and product liability in Brazil: overview

The potential number of patients to be treated with the product. This enshrines the government’s duty to 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.

Recordal of such devices need not be renewed. Assurance of information concerning the methodology used before and during the trial, including the possibility of inclusion in a control or placebo group.

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

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

In addition, all medical devices, regardless of the class must comply with principles of safety and effectiveness, as provided by Resolution No. Prices are reviewed annually in March and this review considers diverse factors, such as level of inflation, productivity and sector competition. The possibility to request designation as a rare disease drug. The whole process generally takes from one to two years, depending on the category of the medicine and on possible office actions that may be issued during ANVISA’s analysis.


In addition, to obtain ANVISA’s approval, the company must file a detailed protocol before the ethics committee CEP of the institution in which the clinical trial will be performed, to have all ethical aspects of the trial analysed.

Funds are transferred from the National Health Insurance Fund to the other regional governments. There is no direct or indirect reimbursement to end users or pharmacists in Brazil.

Infor the first time the price readjustment index was above inflation, reaching a maximum xcb Monitoring compliance and imposing penalties ANVISA, as well as state and municipal entities, are responsible for inspecting and enforcing compliance with food and drug laws. Other anvida There are also specific requirements for prescription medicines, and specific warnings regarding children, free samples and routes of administration.

If medicines are not marketed within a certain period, marketing approval cannot be renewed. This is the Brazilian Presidency’s website. Article of the Angisa Constitution FC The cost per patient of treatment with the product.

A comparator product must be elected. Are there further conditions concerning how the drug is distributed and accessible to patients?

All the information that does not fit in the external packaging must be contained in the insert packaging. ANVISA, as well as state and municipal entities, can impose administrative penalties such as fines for statutory sanitary infringement, after administrative prosecution.

Under this system, labels can include a code that identifies the medicine and its registration information. The price charged by the company in foreign countries. Consent The consent provisions set out in Resolution No.


This includes monitoring the existence or lack of the necessary marketing authorisation. There are several laws, rules and regulations that address prohibitions or restrictions on providing items of value to public officials at the different federative levels.

Ministério da Saúde

Federal, state and county executive governments maintains SUS through a variety of taxes and contributions. Publishing the approval in the Official Gazette.

Types of indemnity to cover possible injury resulting from the trial. There are several medicines and treatments that SUS does not provide. Forms of reimbursement of current expenditure resulting from participation in the trial. Despite being under discussion, the Bill is a key driver towards more efficiency and dialogue to enhance the system.

The price readjustment reached a maximum of 4. There is no guideline on how such provision will be implemented yet. Those versions are only for information purposes and do not have any binding effect. Brazilian statutory legislation provides for the protection of undisclosed test data that must be submitted to the Brazilian regulatory authorities to obtain official approval for the marketing of pharmaceutical products, patented or not.

Substantive test A pharmaceutical product is considered to be defective when it is unfit or inadequate for consumption, or when there are contradictions between the product and its packaging information.