New self-declaration forms are approved to open a new pharmacy, gross pharmaceutical trade, pharmaceutical import-export or pharmaceutical agency. Authorities from the National Center for the Control of Drugs, quoted in the press (Panorama 16.03.2009, p6), estimate this to be a favorable step in the facilitation of the licensing process. False declaration will be sanctioned with a 5 year prohibition to exercise in the pharmaceutical market. The self-declaration form addresses questions concerning public health issues as well as economical and legal issues: registration or not as a juridical person at the National Center for Registration, hygienic and sanitary permission to exercise, certificate of former tax payment, declaration of not being object of legal action in the field of activity that is the object of the demand, and declaration of meeting other formalized requirements. These latter include disposal of at least 90 m2 for gross pharmaceutical trade and 35 m2 for pharmacies, 15 m2 for pharmaceutical agencies. The pharmaceutical entities should declare if their practices comply with the “Good Practice of Stocking Drugs” and “Good Practice of Distributing Drugs” according to the existing laws. On the other hand, replying to an economic concern, the distance between two pharmacies should be at least 100 to 150 meters.
Facilitated entry in the pharmaceutical market.
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