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Regulatory Focus™ > News Articles > Brazil: New Rules on Pharmacies and Wholesale Distributors

Brazil: New Rules on Pharmacies and Wholesale Distributors

Posted 02 April 2012 | By Ansis Helmanis

The same company can now own pharmacies as well as drug distribution centers, as long as the activities are conducted in separate establishments, according to regulations issued by Brazil's national regulatory agency, ANVISA, on 26 March. Companies that apply for permission to distribute drugs must comply with the requirements of Good Distribution Practice and Storage established by ANVISA. Before engaging in an additional activity, a company must first obtain an ANVISA Operating Permit (AFE), and a Special Permit (AE) if the company plans to distribute controlled drugs such as narcotics or psychotropic substances. 

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Empresas podem atuar como drogarias e distribuidoras de medicamentos

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