WebMarch 2024 Transition period. Main aspects 1. Centralised assessment 2. Single Resolution for APIs (RDC 359/2024) 3. Direct communication with DIFA holders (Brazilian or foreign) ... •A GMP Certificate of the API manufacturer issued by ANVISA will be a requirement for a marketing authorisation or addition of API manufacturer (RDC 361/2024). WebANVISA Draft Resolution number 748, November 22, 2024 – previously notified through G/TBT/N/BRA/944 – which establishes technical requirements for packaging, coatings, utensils, covers and equipment in contact with foods, was adopted as Resolution – RDC number 498, May 20, 2024.
Life Sciences Newsletter No.9 – December 2024 - Demarest
WebJan 12, 2024 · ANVISA – National Health Surveillance Agency. Anvisa publishes documents on low-risk drugs. On December 20, 2024, the Brazilian National Health Authority (“ANVISA”) published a Q&A document regarding medicines that are subject to notification, clarifying doubts about the Resolution of the Collegiate Board (RDC) 576/2024 and Normative … WebMay 6, 2024 · A more complete ANVISA definition is “a description of results and of analytical activities used for detection, identification, structure elucidation, and quantitative determination of degradation products present in the active pharmaceutical ingredient and the drug product” (Ref. 1 – Art. 3.VI). smart business administration
ANVISA New Regulatory Framework for APIs
http://antigo.anvisa.gov.br/en/english WebDec 12, 2024 · In the federal public regulatory structure, the agency is connected to the Ministry of Health. ANVISA’s primary goal is to protect and promote public health, by … WebInform your Brazil Registration Holder and the National Sanitary Surveillance System (SNVS) that a reportable adverse event has occurred. Inform your Registration Holder and … smart business analyst