This Resolution establishes the minimum criteria and conditions for compliance with Good Pharmaceutical Practices for the sanitary control of the functioning, dispensing and commercialization of products and the provision of pharmaceutical services in pharmacies and drugstores.
For the purposes of this Resolution, Good Pharmaceutical Practices are understood to be the set of techniques and measures that aim to ensure the maintenance of the quality and safety of the products made available and the services provided in pharmacies and drugstores, in order to contribute to the rational use of these products and improving the quality of life of users.
The provisions of this Resolution apply to pharmacies and drugstores throughout the national territory and, where applicable, to public pharmacies, medication stations and mobile units. Private service establishments of a hospital unit or any other medical assistance equivalent are subject to the provisions contained in specific legislation.
Every pharmaceutical establishment must have:
- Company Operating Authorization (AFE) issued by the Sanitary Surveillance;
- Sanitary Permit issued by the competent body of the State or Municipality;
- Certificate of Technical Regularity issued by the Regional Council of Pharmacy;
- Special Operation Authorization (AE) issued by ANVISA (pharmacies that sell controlled products)
Also, according to updated RDC 44, it is necessary to ensure that all internal areas of the establishment have good physical and structural conditions, allowing constant hygiene of the place. Facilities must have interior surfaces such as floors, walls, and ceilings; smooth and waterproof.
All these criteria must comply with the provisions of the resolution, all of which are periodically evaluated by the municipal health surveillance, through the renewal of the Sanitary Permit license. That is, the pharmacy will be able to undergo inspections each year to ensure that it is meeting the physical infrastructure requirements.