Active pharmaceutical ingredients (APIs)

Manufacturers of active pharmaceutical ingredients (APIs) are not the authorisation holders. They therefore come into contact with the IGJ less often. GMP inspections of these companies are carried out, but only on request by the EMEA, MEB, EDQM or the manufacturer themselves.

The legislation (European Directive 2011/62/EU) does impose requirements on the production of active ingredients. The aim is to prevent falsified medicinal products from getting into the legitimate distribution chain for medicinal products. This FAQs about active substances (in Dutch) in medicinal products gives more information about the subject.