For a site in the Netherlands, IGJ is the inspectorate. This is the authority whose findings determine your GMP certificate, and whose priorities are worth tracking.
IGJ carries out GMP inspections of manufacturers in the Netherlands. Marketing authorisation is a separate matter, handled by CBG-MEB.
Official sitePublished by IGJ. Verify current status at the source.
The inspectorate's own material on its supervision of the medicines sector, including its published priorities.
Read the full articlePublished by IGJ. Verify current status at the source.
The English-language presentation of the inspectorate's remit and approach.
Published by IGJ. Verify current status at the source.
The Dutch medicines authority responsible for marketing authorisation. Distinct from IGJ, and a common source of confusion when routing a regulatory question.
GMPConsultant.nl is an independent advisory. It is not a regulator, a notified body or a certification body. Explanations on these pages are our interpretation, published separately from the official text so the two are never confused. Always verify against the primary source before acting — guidance is revised, and a page here may not reflect the most recent position.
Knowing what a source says is the start. The Health Index turns it into a scored position across seven domains, and the knowledge base explains where each requirement goes wrong in practice.