7. When it is possible to obtain a GDP certificate for distributor of medicines and what the certificate documented?

GDP certificate for the distributor of medicinal products is issued by the Institute since 2. 4. 2013 in accordance with the requirements of the legislation within 90 days from the date of termination of the inspection. The issued certificate attests that the distributor carries out the obligations and is regarded as a body fulfilling the requirements of good distribution practices as provided for in Article 84 of Directive 2001/83 / EC, as amended, and § 77 par. 1 point. g) of the Act on Pharmaceuticals. It is issued after an inspection for each storage place of the distributor in particular. The validity is determined by a maximum of 5 years, but in justified cases it is possible to limit its. Restrictions may relate to the period of its validity as well as to the scope of the certified distribution activities. Furthermore it is possible to obtain a GDP certificate in the context of operations performed by the Institute on request.