BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
ies for the purposes of registration and post- registration changes to biological products. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Marketing authorisations for pharmaceuticals and medical devices are valid for ten years from the date of their publication in the Brazilian Offi- cial Gazette (DOU). They can be renewed for successive ten-year periods. Certain requirements must be met for renewal, for example, for medicines, the product must have been marketed for at least 80 months (two- thirds) of the ten-year period (120 months). For medical devices, for example, revalidation of the registration must be requested no more than 12 months and no less than six months before the registration expires. The registration of a product which is subject to health surveillance may be cancelled in the following situations. • When the renewal of the product’s registra- tion has not been requested within the period specified by ANVISA. • When it is proven that the product or manu- facturing process may present a risk to the health of the consumer, patient, operator or third parties involved. • When a request from the holding company is made when it no longer has any interest in marketing the product. • When a request from the holding company is made when the registration is to be trans- ferred to another company. In addition, ANVISA can take preventive meas- ures to protect public health during a health
risk assessment. These measures, authorised by Law 6,360/1976, Law 9,782/1999 and Law 9,784/1999, include inspection actions such as seizure, recall, prohibition and suspension of activities relating to the product or service in question (storage, marketing, distribution, man- ufacture, import, advertising and/or use). Furthermore, ANVISA can utilise precaution- ary measures, which are also proactive admin- istrative actions based on the terms of Law 6,437/1977. These measures aim to safeguard public health in situations of imminent risk, even before a formal hearing with the party involved. For example, a precautionary interdiction can be applied when there is clear evidence of product alteration or adulteration. Once a health investigation is completed and an infraction is confirmed, ANVISA initiates the process of charging the responsible party. Pen- alties for sanitary infractions, as defined in Law 6,437/1977, can be applied individually or in combination. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices The process for obtaining marketing authorisa- tion for pharmaceuticals and medical devices in Brazil is overseen by ANVISA. What follows is a summary of the steps. • Pre-application: (a) compile all necessary data and documen- tation; and (b) evaluate risk classification and seek pre- submission consultations with ANVISA. • Formal application: (a) submit a comprehensive dossier electron- ically through ANVISA’s online platform.
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