BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations The regulations concerning the obligation on the marketing authorisation for pharmaceuticals and medical devices are summarised below. Pharmaceuticals (Medicinal Products) Marketing authorisation (MA) process • RDC 31/2014 (in force but amended by RDC 438/2020) defines procedures for obtaining an MA in Brazil, including documentation requirements and evaluation timelines. • ANVISA (National Health Surveillance Agency) oversees the process. • Phases include pre-clinical studies, clinical trials (Phases I-III) and post-marketing (Phase IV) studies. Pharmacovigilance obligations (medicinal products) RDC 658/2022 establishes General Guidelines for Good Manufacturing Practices for Medicines. Post-marketing obligations Phase IV trials may be imposed to monitor real- world safety and efficacy. Medical Devices RDC 751/2022 (in force but amended by RDC 777/2023 and 810/2023) regulates the risk clas- sification, notification and registration regimes, labelling requirements and instructions for use of medical devices. • Technovigilance obligations – manufacturers must actively participate in technovigilance. • Post-marketing obligations – similar to phar- maceuticals, ongoing safety assessment is crucial.
The following are some resolutions regarding the control, inspection and monitoring of products and services: • RDC 67/2009 (in force but amended by RDC 702/2022) – technovigilance standards appli- cable to health product registration holders in Brazil. • RDC 551/2021 – obligation for registration holders to carry out and report field actions, meaning actions of a health product with the aim of reducing the risk of an adverse event related to the use of the health product already on the market of health products in Brazil. • RDC 665/2022 – Good Manufacturing Prac- tices for Medical Products and Diagnostic Products for In Vitro Use. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices In the realm of third-party access to pharmaceu- tical and medical device authorisations, regula- tion is governed by the Information Access Law (Law 12,527/2011). Despite the sensitivity and confidentiality of health products, interested third parties can request access to registration information under this Law. Article 7 states that access to information includes obtaining data from records or docu- ments produced by relevant bodies or entities, whether stored publicly or not, as well as infor- mation concerning public asset administration, resource usage, bidding and administrative con- tracts. However, it is important to note that while all information regarding a registered health prod- uct may be requested, it may not always be pro- vided by regulatory agencies such as ANVISA or
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