BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
to operate by ANVISA, but the prior submission of a complete safety and efficacy dossier is not required. The authorisation results from the correct classifica- tion of the product within the applicable regulatory category and compliance with the technical and legal requirements set forth in the relevant regulation, with the company remaining responsible for the product’s conformity and subject to sanitary inspection. For medical devices, the procedure for obtaining marketing authorisation varies according to risk clas- sification. For Class III and IV devices, the applicant must submit a registration application accompanied by a technical dossier demonstrating compliance with the essential requirements of safety and performance, including information on design, manufacturing, risk management, clinical evidence where required, label- ling and instructions for use. For Class I and II devices, authorisation is obtained through notification, a proce- dure in which the manufacturer or importer declares the product’s conformity with the applicable regula- tions. These procedures are primarily governed by ANVISA RDC No 751/2022. Once marketing authorisation has been granted, the legislation allows for its variation. In the case of registered medicines, significant changes, such as modifications to therapeutic indications, formulation, posology, target population, manufacturing process, packaging, labelling or package leaflet, are subject to the post-registration regime, requiring prior approval by or notification to ANVISA, depending on the impact of the change. For medicines exempt from registra- tion, changes must be reflected through updates to the notification or listing whenever they affect the orig- inal conditions of classification. For medical devices, variations follow a similar logic and are regulated by ANVISA RDC No 751/2022, according to the risk class and the relevance of the modification. Brazilian legislation also allows for the transfer of mar- keting authorisation between holders. For medicines subject to registration, the transfer of registration ownership requires prior approval by ANVISA, with evidence that the new holder fully assumes the cor- responding regulatory responsibilities. For medicines exempt from registration and for notified or registered medical devices, the transfer requires the correspond-
ing regulatory update before ANVISA, in accordance with the procedures set forth in the applicable regula- tions. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations General Framework While the general rule in Brazil requires that medicines and medical devices obtain a valid marketing authori- sation (registration, notification or listing) from ANVISA before being supplied, regulated exceptions allow patient access to unauthorised products in limited and carefully controlled situations when no satisfac- tory therapeutic alternative is available. These excep- tions are established in specific ANVISA regulations. Medicines: ANVISA RDC No 38/2013 The main regulatory basis for access to unregistered medicines is ANVISA RDC No 38/2013, which gov- erns expanded access programmes, compassionate use and post-trial supply. Prior ANVISA authorisation may be obtained for programmes providing experi- mental or clinically developing medicines to patients with serious or life-threatening diseases, provided criteria such as disease severity, absence of satisfac- tory therapeutic alternatives in Brazil and a favourable risk-benefit assessment are met. • Compassionate use is intended for individual patients suffering from a serious or life-threatening condition for which no registered therapeutic options are available, permitting use of a new, promising medicine not yet registered in Brazil. ANVISA’s authorisation is personal and non-trans- ferable, initiated through a request submitted by the sponsor or responsible technical party. • Expanded access allows supply of medicine still under clinical investigation to larger groups of patients, particularly when there is evidence of potential benefit and no adequate registered thera- peutic options exist in the country. • Post-trial supply ensures continuity of treatment for clinical trial participants who benefited from the medicine after study completion or termination of their participation, in accordance with RDC criteria and monitoring requirements.
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