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

DICOL (ANVISA’s Collegiate Board), in a virtual meeting ended on 11/01/2023, has confirmed a decision, issued in February of 2005, in the sense that, it is allowed for the same company to use different trademarks for medicines that have the same active ingredients, or the same indications (trademark duality).

Updating of the “Reference Medicines” list, for the purposes of Resolution RDC 35/2012

Normative Instruction – IN 265/2023, that amends Normative Instruction 106/2021, that creates the List of Low-Risk Medicines, subject to notification.

RESOLUTION – RDC 827/2023, that updates Annex I (List of Substances that are Narcotics, Psychotropics, Precursors and others under Special Control, as regulated under Ordinance SVS/MS 344/1998.