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), through the Normative Instruction No. 32/2019 (IN 32), established the proceedings for States, Federal District and Municipalities to comply with the requirements set forth in the Resolution No. 207/2018 (RDC 207), which had authorized such local bodies to perform GMPs inspection of API's, Medicines', and Health Products' (Classes III and IV) manufacturers.
Federal Council of Medicine publishes Resolution authorizing the use of discount cards
On April 5, 2019, the Federal Council of Medicine (CFM) published Resolution No. 2,226/2019 considering no longer unethical the disclosure of prices and methods of payment for medical appointments, and authorizing the association of physicians with companies that advertise discounts over medical fees through discount cards.
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