H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, Fax: (1) 8869-460

Mail: 1372 P.O. Box: 450.

MAGYAR

Good Manufacturing Practice – GMP

Good manufacturing practice is part of the quality assurance system in the pharmaceutical industry which ensures the medicinal product to be manufactured and controlled according to the requirements prescribed, the facts stated in the Manufacturing Authorisation and to be appropriate for the purpose they have been granted.

Any manufacturing process of medicinal products in Hungary (this includes manufacturing and packaging of active substances, manufacturing, batch release and quality control of medicinal products) has to be carried out only in possession of a valid manufacturing licence for medicinal products issued by the National Institute of Pharmacy.
Authorisation process

The National Institute of Pharmacy will grant the manufacturing authorisation for medicinal products at a particular manufacturing site only in case if the inspection and the correction-improvement measures ascertain that the manufacturing site works according to the current law, decrees and GMP directives.

If any crucial fault would be disclosed by the inspection this means that the manufacturing site does not meet the requirements stated in the laws. The National Institute of Pharmacy will not propose granting the manufacturing licence for the medicinal product in this case.

Suspension and withdrawal procedures

If any crucial fault would be disclosed by the GMP inspection at the manufacturing site owning a manufacturing licence the National Institute of Pharmacy will suspend or withdraw the manufacturing authorisation for medicinal products. This will be proceeded on the inspector's initiative.

For licenesed manufacturers in Hungary please find list No. 13 here.

 

Last updated: 2015.01.29 18:13