BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
to Class I and II medical devices do not have a fixed validity period; they remain effective as long as the technical, regulatory and compliance conditions that supported the product’s regularisation are maintained, subject to ongoing data update and post-market sur- veillance obligations under ANVISA RDC No 751/2022. Renewal Mechanisms For medicines, renewal may be requested by the reg- istration holder following ANVISA-defined deadlines and procedures. ANVISA may require additional evi- dence or new studies supporting quality, safety and efficacy. The agency currently uses both ordinary and simplified renewal mechanisms based on sanitary risk and the holder’s regulatory compliance history. For Class III and IV medical devices, renewal for an equivalent ten-year period applies, provided the request is submitted prior to expiration. Notifica- tions for Class I and II devices do not require periodic renewal but are subject to ongoing data updates and post-market surveillance obligations. Grounds for Revocation, Cancellation, Suspension, Variation or Withdrawal The grounds are as follows. • Non-use (failure to market): Article 21, paragraph 3 of Law No 6,360/1976 authorises ANVISA to can- cel a registration when the product is not placed on the market within one year following authorisation. • Risk to public health: Under Article 7 of Law No 6,360/1976 and Article 7, item XV of Law No 9,782/1999, ANVISA may vary, suspend or with- draw authorisation on a preventive or corrective basis when a product is determined to be harmful, ineffective or unsafe, or presents quality deviations. This includes ordering product recalls. • GMP non-compliance: The absence, loss or sus- pension of a GMP certificate, or critical deficiencies identified during sanitary inspections, undermines product quality assurance and authorises ANVISA to adopt restrictive measures, since manufacturing compliance is essential for maintaining registration or notification. • Post-registration irregularities: Authorisation may be withdrawn for implementing unauthorised changes to the manufacturing process, manufac-
turing site, composition, therapeutic indications or labelling, as well as failure to comply with pharma- covigilance obligations (medicines) or technovigi- lance obligations (medical devices). • Fraud or misrepresentation: Authorisation may be revoked for fraud, submission of false informa - tion or omission of relevant data in the regulatory process, as these circumstances undermine the sanitary authority’s confidence in the safety, quality and efficacy conclusions supporting the original authorisation. 3.4 Procedure for Obtaining a Marketing Authorisation In Brazil, the granting of marketing authorisation for medicines and medical devices takes place through formal administrative procedures before ANVISA, structured according to the sanitary risk of the prod- uct and its legal nature. For medicines subject to registration, the procedure begins with the company’s authorisation by ANVISA, which requires obtaining an authorisation to operate ( Autorização de Funcionamento de Empresa – AFE) and, where applicable, a special authorisation ( Autori- zação Especial – AE). Subsequently, the applicant submits, through the agency’s electronic system, a registration application accompanied by a technical and administrative dossier containing comprehensive information on the medicine, including its composi- tion, pharmaceutical form, manufacturing process, quality controls, stability studies, labelling and pack- age leaflet, as well as data demonstrating safety and efficacy, according to the product category. It is also an essential requirement that the manufacturer holds a valid GMP certificate. ANVISA conducts a technical assessment of the application and, upon verification of compliance with the applicable legal and regulatory requirements, grants the sanitary registration, which constitutes the authorisation for commercialisation of the medicine in the national territory, pursuant to Arti- cle 12 of Law No 6,360/1976. For medicines exempt from registration because they are considered low risk, marketing authorisation is obtained through a simplified procedure, gener- ally in the form of product notification or listing. In this case, the company must also be duly authorised
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