NORMATIVE INSTRUCTION – 241/2023, that amends Nomative Instruction 162/2022, that specifies the acceptable daily ingestion (IDA), the acute reference dose (DRfA) and the maximum residue limits (LMR) for active ingredients of veterinary medicines, in food of animal origin.
Updating of the “Reference Medicine” list, for the purposes of Resolution RDC 35/2012 RESOLUTION – RDC 808/2023, that amends RDC 768/2022, containing the new Regulatory Framework for labeling of Medicinal Products.
RESOLUTION – RDC 807/2023, that regulates the importation of goods and services subject to sanitary surveillance through the Single Import Declaration (Duimp).
ORDINANCE 863/2023, that sets forth the competences and procedures for the review and consolidation of normative acts, under the level of Decree, within the National Sanitary Surveillance Agency – ANVISA.
ANVISA and the State of São Paulo, enter into a collaboration agreement in the area of pharmacovigilance, with the use by the State of São Paulo, of the “VigiMed System”, for the notification of medicines related adverse events.
RDC 809/2023, that amends RDC 585/2021, that approves and enacts the By-laws of ANVISA. Ordinance 875/2023 that creates the Technical Chamber of Medicines Registration (CATEME).
CATEME’s purpose is to perform technical studies and issue recommendations related to the registration of medicines and biological products, to serve as a source of technical guidance to help in the procedure for evaluation and decision making in the scope of the registration of these products and of clinical research.
RESOLUTION – RDC 810/2023, that amends RDC 751/2022, that regulates the risk classification, the notification and registration notices, and the labeling requirements and use instructions of medical devices.
RESOLUTION – RDC 811/2023, that amends RDC 204/2017, that regulates the fitting within the priotity category, of petitions for registration, post´registration, and previous consent in medicines clinical studies, and amends RDC 205/2017, that sets forth special procedures for consent in clinicas studies, certification of good manufacturing practices, and registration of new medicines for treating, diagnosing, and preventing rare diseases.
NORMATIVE INSTRUCTION – IN 244/2023, taht defines the list of substances classified as prescription antimicrobian, isolated or in association, as regulated under RDC 471/2021.
First edition of the Questions & Answers (Q&A) about activities related to clinical analysis tests that can be performed in pharmacies.
