The new codes only address the type of application without specifying the regulatory category of the medicine.
August 9, 2023
On July 3, Collegiate Board Resolution(RDC) 768/2022, which deals with the new rules for drug labeling in Brazil, entered into force. With this, Anvisa also updated the subject codes for petitions on the subject.
Aiming at regulatory simplification, there will be a reduction from 26 to four codes. The new codes address only the type of petition(amendment, notification, inclusion of new destination and adaptation to RDC 768/2022), without specifying the regulatory category of the medicine.
ELS can and is able to consult and assist with labeling issues for medicines and other products in Europe and LATAM to comply with current legislation. Please contact your local ELS consultant via this link: https://www.els-solutions.com/onde-estamos/ or via email: email@example.com