Manufactres and Importers of Medicinal Products shall observe ANVISA’S New Regulation

On 10/23/2019 the National Health Surveillance Agency (ANVISA) published the Resolution of the Collegiate Board No. 317/2019, which provides for the expiration dates and the necessary documentation to maintain the regularization of medicines.

The regulation establishes new deadlines for medicines registration and defines rules regarding the notification and interest declaration for marketing continuity.

For registration renewal, petitions already received will be reviewed under the new terms and the new rules will be applied automatically, upon observance of the defined exceptions.

This normative will be effective on ninety (90) days from its publication.

The Public Law and Regulatory Department of NHM Advogados will keep following up the developments of the matter and will be at your service to render any assistance related to the issue.