Our partner Marcos L. Freitas Levy presents the main new standards published by ANVISA in September.

RESOLUTION – RDC 812/2023, that amends Ordinance SVS/MS 344/1998, that sets forth the Technical Regulations on substances and medicines subject to special control, and RDC 44/2009 that regulates Good Practices in Pharmacy related to the sanitary control of the operation, delivery, and commercialization of products and pr6ovision of pharmaceutical services in pharmacies and drugstores.

This Resolution allows that pharmacies and drugstores make (remote) home delivery of medicines subject to special control (controlled medicines)

RESOLUÇÃO – RDC 816/2023, that updates Annex I (List of Substances classified as Narcotic, Psychotropic, Precursor, and Others under Special Control) regulated under Ordinance SVS/MS 344/1998.

On 09/22/2023 ANVISA published a document containing Questions & Answers on the interpretation of RDC 768/2022 that regulates the labeling of medicines.

ORDINANCE 1.079/2023, that sets forth criteria and procedures to formalize the management of Cooperation Agreements with national entities within the scope of ANVISA, in the cases where ANVISA joins as the organ that holds the governance of the partnership.

ANVISA published a Guide to help companies in the implementation of Real World Evidence (RWE), to be used in support to the development of new medicines, or new indications. The Guide defines the technical requirements to demonstrate safety and efficacy of medicines, based in real world data, supplying importa6nt directives for the collection and analysis of data for the pharmaceutical industry.