On December 2020, ANVISA published the Public Consultation for Revision of DRC Nº 47 of September 8th 2009, which establishes the rules for drafting, harmonization, updating, publication and availability of drug package leaflet for patients and health professionals.

This proposal is related to the possibility of providing access to digital technologies that can benefit patients and health professionals with updated electronic information. In addition to the consequent minimization of environmental impacts and the adoption of more sustainable practices.

Please see below the main updates brought by Public Consultation:

• Possibility of including digital mechanisms that can be made available in the primary and secondary packaging, in order to facilitate the availability of the updated version of the package leaflet in the Anvisa Electronic System.

• In the case of drug products for acute use that are dispensed to the patient in the primary packaging, the number of package leaflets for the patient in the multiple packaging should be equivalent to at least 50% (fifty percent) of the number of primary packages.

• Companies that have the Non-prescription medicines Marketing Authorization should institute education programs to guide points of sale to make the package leaflets available and patients to request these package leaflets in pharmacies in order to promote the safe use of medicines.

Access the full draft at the link: https://bit.ly/3pBaK82

Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.

Contact us: info@vitaraconsulting.com