BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
• Technical evaluation: (a) ANVISA experts assess safety, efficacy and quality; and (b) inspections of manufacturing facilities or clinical trial sites may be conducted. • Decision and issuance: (a) ANVISA issues a final decision approving or rejecting. It is also possible that it may request further information for making such decision; and (b) if approved, ANVISA issues a marketing authorisation document. Variations to marketing authorisation: • similar process, but typically less extensive; and • complexity depends on the nature of the change: minor, moderate or major. Transfer of marketing authorisation: • eligibility is limited to specific corporate operations such as mergers or successions; • procedures are outlined in RDC 903/2024; • deadlines vary by product category; and • no other changes are permitted in the transfer petition. Steps for submitting a registration transfer request: • petitioning; • fees; • protocol; • statement of the corporate or commercial transaction carried out, as set forth in Annex I of RDC 903/2024; • a certified copy of the operating licence or sanitary permit issued by the competent authority, updated to reflect the corporate or commercial change; and
• monitoring Important points: • the registration number follows a specific formation process; and • the validity of the registration remains the same regardless of the transfer publication date. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations In Brazil, patient access to pharmaceuticals and medical devices typically requires ANVISA’s mar- keting authorisation. However, exceptions exist. • Clinical trials – patients can join strictly regu- lated trials for new products. This requires informed consent. • Compassionate use programmes – eligible patients with life-threatening conditions and no alternatives may access unapproved prod- ucts under strict criteria: (a) eligibility – determined on a case-by-case basis; (b) physician request – detailed justification submitted to ANVISA; (c) ANVISA approval – evaluation based on risks and benefits; and (d) limited availability – access granted from a limited supply, often from the manufac- turer. Compassionate use is not guaranteed, and ANVISA holds final approval authority.
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