4. Brasil. Lei no , de Anvisa reforça alerta para os riscos sanitários provocados pela Lei no 6 ago. ANVISA. Homeopatia esta regulamentada pela lei artigo Política Nacional de Práticas Integrativas para o Sistema Único de Saúde. According Agência Nacional de Vigilância Sanitária (Anvisa – Brazilian Na- tional Health . The Brazilian law /, established the sanitary control to sale of medicines, drugs [5] Brasil. Lei no de 24 de setembro de

Author: Tojakazahn Mazulrajas
Country: Denmark
Language: English (Spanish)
Genre: Spiritual
Published (Last): 14 October 2011
Pages: 119
PDF File Size: 13.91 Mb
ePub File Size: 7.94 Mb
ISBN: 252-4-67192-661-7
Downloads: 63724
Price: Free* [*Free Regsitration Required]
Uploader: Akinoran

However, the federal sphere still retains inspection activities. The interested party should consult the list of reference drugs in the Anvisa website, submit Import License and Notice for production of pilot batches, etc. Anviaa well as the content of advertising, the control of the sale of pharmaceutical products also covers their labelling, which is required to obey speciic stan- dards of form and minimal informative content. Conselho Federal de Medicina.

The objective of this paper is to ofer a broad introduction to the Brazilian Pol- icy on Regulation of Drugs and Medications, presenting the reader with the bases of the regulation currently in force, so as to enable the development of deeper discussions on Brazilian policies, or on the strategic lines of the existing regulation, with a view to its permanent improvement.


The information contained in advertising for drugs must be complete, clear and formulated in a way that does not highlight only the beneicial aspects of the product, since every drug has inherent risks in its use. In addition to the oices, it is possible to see a variety of institutions responsible for surveillance, in accordance with the inancial conditions and managing options of each State and city. In other words, the State guarantees and takes responsibility over the product’s marketing and consumption, based on the scientific evidence resulting from clinical trials.

One of the biggest obstacles to articulation between the INPI and Anvisa lies in the fact that they lean towards opposing points of view on incremental innovations. During pre-registration, it is necessary to present protocols for clinical re- search, in the case of a national new product.

For this reason, beyond the prior control on availability of pharmaceutical prod- ucts in the market, which is carried out through registry, Anvisa adopts other measures of control with the objective of rationalizing the use of drugs and medications, through the preparation of rules for advertising of those products, their availability and traceability.


The simpliied process may also be applied when the trial has already started recruiting trial subjects in another country which is participat- ing in the same trial.

Cienc Cult ; 3 Drugs that require special control must be prescribed in two copies, one being obligatorily retained at the pharmaceutical establishment.

The following item presents a brief xnvisa of the system implemented to protect industrial property in Brazil, which was set up to allow new pharmaceutical products to be marketed 5919 guaranteeing patent protection for the inventor. Before a drug or medicine can be registered and authorized for sale in Brazil, a clinical trial in human beings must be conducted.

To avoid abuse in the inluence of economic factors in the act of prescription, the Code of Medical Ethics establishes, in its Article 68, that the exercise of the medical profession must take place with total independence in relation to the organizations that sell medical prescription products.

The rationale for this pulverization, even though the studies for the stability and validation of phytotherapicals follow the general leo established by Anvisa for medications, it is the complexity of its composition, which in theory, would have led to the need to adopt speciic guidelines, in language that would enable easy interpretation and serve as guidance for the Agency. Good clinical research practices GCRP are of fundamental importance for the development of clinical trials and, through them, the execution of all procedures, based on rights and obligations of both the companies and in- dividuals, is assured.

The Informed Consent Form is a document through which the study subject or patient conirms he or she voluntarily consents to take part in a given clin- ical trial after having been informed of the nature of the study, i. Brazilian law makes a distinction between drugs for licit and illicit use.

Even so, rela- tionships in advertising of drugs are very little controlled, especially in rela- tion to transparency. Health regulation policy will be analyzed in regards to its aspects of technique, transparency, social participation, ef- fectiveness and eiciency, based on its objectives, guidelines and legal and institutional arrangements.

The Constitution text establishes: Now, the special authorization AE shall be required by the following establishments, whenever they use controlled sub- stances present in the same Ordinance: Member mandates are three years, with only one renewal being anvida. In this system, it is ancisa to the Union to deine national health surveillance pol- icy, follow and coordinate state and city health surveillance actions, render technical cooperation with them if needed, and more.


Regulatory policies for drugs and medicines in Brazil are based on the Federal Constitution of and on the vast anvusa legislation. Its rules are the result of the leo of research carried out jointly by the Inter-institutional Work Group, comprising repre- sentatives of the Ministries of Health, Justice, Development, Industry and For- eign Trade, and Anvisa itself.

Thus, there abvisa the following types: The study of patents is extremely important for the pharmaceutical industry, as posited by Shadlen: Thus, as ordered by Article 4 of Law n.

The penalty varies from imprisonment for six months to one year, and a ine. In the irst case, the prescription, without speciication of a single treatment, authorizes the pharmacist to dispense either a generic or a non-generic drug. A patent may be terminated in accordance with Chapter XI of the IPL Article 78due to the end of its validity term, due to the resignation of its holder; by forfeiture; by failure to pay the annual fee to the INPI.

The regulatory structure of public policies, even if resulting from an initiative of the Executive Branch, lies primarily with eli Legislative Branch, which deines public policy by means of laws. The registration process includes the certiication of the GMPs, i. It is a procedure that starts from scratch on the accu- mulation of information about the registration of the medication.

Copy of Copy of Seminário de homeopatia by Gustavo Martello on Prezi

We must briely pe- ruse the history of pharmaceutical regulations in Brazil in order to understand how and why drug policies in Brazil are established as they currently are. Approved through Ordinance n. Registration of new medicines They are the innovative medicines61, that constitutes reference, and their ac- tive principles may be synthetic or semi-synthetic.

Promotion of the rational Through educational actions discouraging self-medication, use of medicines restricting certain professionals from prescribing and dispensing medicines, incentives for generic drugs.

The liability for civil damages may be acted upon: Renewal is required after this period. According to the interpretation, jointly, of the code of medical ethics Resolu- tion n. The initial analysis of the documents and the veriication of the technical, le- gal and operational capacity required for authorization are made by the State or Municipal health authorities, within 60 days.