H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

GDP Inspections


Arrangement of GDP inspections

The National Institute of Pharmacy – as the responsible authority for the supervision of wholesale trade of medicinal products – makes certain through their inspectors that wholesale trade of medicinal products meet the requirements stated in the concerning laws.

Purpose of GDP inspections

If a legal person applies for a wholesaling authorisation for medicinal products the condition of issuing the licence is a successful local GDP inspection.

Following the above mentioned process the legal person owning wholesaling authorisation for medicinal products is being inspected at their seat regularly by the competent authority to follow the activity of the wholesaler with attention continuously. According to the EU requirements frequency of these GMP inspections is once in two or three years’ time.

The National Institute of Pharmacy has the right to make an exceptional GDP inspection if a fault with the quality or in the wholesale trade of the medicinal product or if any essential changes in the circumstances concerning the wholesale trade occur.
Last updated: 2018.09.30 12:22