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

ORDINANCE 1.100/2023 that sets forth the Innovation Policy of the National Sanitary Surveillance Agency (ANVISA).

RESOLUTION RDC 891/2023, that amends RDC 429/2020, that regulates the nutritional labeling of packed food products. The RDC allows that, products referred to in article 50 (those already in the market), may use, until 10/09/2024, the inventory of packages and labels purchased up to 10/08/2023

RESOLUTION RDC 820/2023, that amends RDC – 034/2013, that institutes the standardized procedures, programs, and documents t be adopted by the National Sanitary Surveillance System (SNVS), to standardize the activities related to inspections in medicines, medical devices, and pharmaceutical inputs related companies and the sending of reports through the “CANAIS” system.

RESOLUTION RDC 821/2023, that amends RDC 053/2015, that sets forth parameters for the notification, identification and, qualification of degradation products in medicines with synthetic and semi-synthetic active ingredients, classified as new, generics, and similar products.

RESOLUTION RDC 822/2023, that publishes the updated list of Brazilian Common Denominations (DCB).

ORDINANCE 1.184/2023, that enacts the Personal Data Protection Policy of the National Sanitary Surveillance Agency (ANVISA), that must be revised and updated periodically, at most every two years.

RESOLUTION RDC 822/2023, that updates the list of Common Brazilian Denominations (DCBs).

RESOLUTION RDC 823/2023, that institutes the pilot project for the implementation of the optimized evaluation procedure, based in risk criteria, to confirm adequacy to the sanitary requirements of the documentation presented to ANVISA in petitions related to medicine’s registration and prost registration changes.