Active pharmaceutical ingredients (APIs)

Companies that deal in active pharmaceutical ingredients have to be registered with Farmatec. They must also comply with the GDP norm for APIs, which came into force in 2015. The IGJ monitors this and started its supervisory activities in 2016. We will start by visiting the companies where we perceive the greatest risks.

The European ‘Falsified Medicines Directive’ (FMD, 2011/62/EU) is intended to prevent falsified medicinal products from entering the legal distribution chain. Aspects of this directive include new requirements imposed on the importers and distributors of APIs. More information about this topic and our supervisory activities can be found in ‘Veelgestelde vragen actieve substanties geneesmiddelen’ (FAQ for APIs, in Dutch).

Check before applying for a certificate: is the OMS data correct?

When new or updated API registrations are issued, they are based on the data about your organisation stored in the Organisation Management Service (OMS) database of the European Medicines Agency (EMA). This will be the standard from 28 January 2022.

Accordingly, before you submit your application you should check that your data in the Organisation Management Service (OMS) database is correct. If it is, you can apply for a new or updated API registration.
This applies to manufacturers, importers and distributors of the active substances found in medicinal products.
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