NEW ANVISA REGISTRATION PROCESS FOR HEALTH-RELATED PRODUCTS

On 29 December 2016, Law No. 13,411/2016 was published in the Federal Register, bringing important changes to the current registration process for health-related products (including medicines, pharmaceutical ingredients and medical devices) at the Brazilian Health Surveillance Agency, ANVISA. The new law will enter into force 90 days after publication.13.411/2016.

Among the changes brought by the law, the following should be highlighted:

• ANVISA’s deadline to approve new drugs and to decide on post-registration requests will change from the current 90 days to: (i) for drug approvals, 120 days (priority requests) or 365 days (ordinary requests); and (ii) for post-registration requests, 60 days (priority requests) or 180 days (ordinary requests).

• A marketing authorisation will only be renewed if the drug to which it relates has been commercialised during the last two-thirds of the term of the marketing authorisation. Currently, the mere industrialisation of the drug during the validity of the marketing authorisation is enough for ANVISA to grant its renewal.

• ANVISA will be required to provide the industry with more information (for example, the status of the analysis, deadline for a decision, and technical grounds) on the processes relating to drug approvals, post-registration requests and marketing authorisation renewals.

Sources: Presidency of the Republic: Law No. 13,411, 28 December 2016 and Presidency of the Republic: Law No. 6,360, 23 September 1976 (Portuguese language).

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”