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).