Newsletter Life Sciences & Healthcare

Author:Mr Marco Aurelio Antas Torronteguy and Elysangela De Oliveira Rabelo
Profession:TozziniFreire Advogados
 
FREE EXCERPT

ANVISA publishes new regulation with standards for the Operating and Special Licenses for pharmacies and drugstores

In the Brazilian Official Gazette of April 10, 2019, the National Health Surveillance Agency (ANVISA) published the Resolution No. 275/2019, establishing a new technical regulation related to the granting, modification and cancellation of Operating Authorization (AFE) and Special Authorization (AE) for pharmacies and drugstores.

The regulation revokes the previous standards on the subject (Resolution ANVISA No. 17/2013) and innovates by creating premises for the creation and implementation of a quality control program with state health agencies under the coordination of ANVISA.

Moreover, the new Resolution modifies the list of acts that do not require a publication in the Official Gazette. Amongst the changes, reduction of activities and change to corporate names of pharmacies and drugstores no longer need to be published.

Finally, another important change relates to the fixation of a 30-day term for ANVISA to analyze AFE and AE applications, which demonstrates the Agency's intention to expedite its review processes.

ANVISA regulates criteria for delegation of GMP inspection

On April 12, 2019, the Brazilian Health Surveillance Agency (ANVISA)...

To continue reading

REQUEST YOUR TRIAL