Good Distribution Practice – GDP

GDP is part of the pharmaceutical quality assurance which enables the medicinal products having been released by the manufacturer before putting on the market to be handled by detailed certification (to be controlled, transported and stored). The medicinal products should also keep their original quality until the date of expiry and hereby meet the requirements included in the Marketing Authorisation and be appropriate for use.

All wholesale trade activities of medicines for human use in Hungary (including the wholesale trade of the active substances and the medicinal products) are to be carried out only in case of having a valid wholesaling authorisation for medicines issued by the National Institute of Pharmacy; or in case of owning a valid manufacturing authorisation for medicinal products as a legally entitled wholesale dealer of medicines.
Authorisation process

If the wholesale dealer is stated by the local inspection and the correction-improvement measures done by the inspectors of the National Institute of Pharmacy to function in compliance with the current laws and regulations the wholesale trade for medicines will be authorised at that particular site by the National Institute of Parmacy with the contribution of Hungarian Trade Licensing Office.

If the wholesale dealer does not meet the requirements prescribed by laws the National Institute of Parmacy will not propose issuing the wholesaling authorisation.

For licenesed wholesalers in Hungary please find list No. 14 here.


Last updated: 2015.01.29 18:13