Inspectorate
General information
Institute issues manufacturing and wholesale authorisations for medicines
Manufacturing/Good Manufacturing Practice
Institute issues a certificate of manufacturing compliance with Good Manufacturing Practice Guidelines
Wholesale/Good Distribution Practice
Institute issues a certificate of manufacturing compliance with Good Distribution Practice guidelines
Good Pharmacovigilance Practice
Pharmacovigilance system is organised in line with Good Pharmacovigilance Practice Guidelines
Good Clinical Practice
Clinical trials are conducted in line with Good Clinical Practice Guidelines
Manufacture/import and distribution of active substances
The Institute registers manufacturers, importers, and wholesalers of active substances in the Register.