Proper production practices are part of quality assurance when making medicinal products. It ensures that the manufacturers always make and check medicinal products in accordance with the quality norms for the intended usage. This is what is known as 'Good Manufacturing Practice' (GMP).
GMP inspections
The principles of GMP are defined in law and described in EU Directive 2017/1572/EU and Delegated Regulation (EU) 2017/1569. The Dutch Health and Youth Care Inspectorate (IGJ) carries out periodic inspections at all medicinal product manufacturers in the Netherlands. During those inspections, which often take several days, we check whether manufacturers are complying with the GMP guidelines. A GMP inspection is generally combined with a Good Distribution Practices (GDP) inspection.
GMP inspections outside Europe
The Health and Youth Care Inspectorate (IGJ), together with other EU Member States, checks whether medicinal product manufacturers comply with legal requirements. They also do so in non-EU countries. More information on inspections outside Europe and how to request such an inspection can be found on the GMP inspections outside Europe page.
GMP inspections for veterinary medicinal products
Together with the Veterinary Medicinal Products department of the MEB, the IGJ also carries out GMP inspections at veterinary medicinal product manufacturers. These are the holders of permits under the Veterinary Medicines Act. These permits can be requested from the Veterinary Medicinal Products Unit.
GMP certificate, permit and site clearance
We advise the Health Minister on applications to obtain or modify production licences. The inspectorate issues advice on request to the Medicines Evaluation Board (MEB) about manufacturers from the authorisation dossier (this is known as a site clearance).
If our finding is that the GMP guidelines are being observed, we issue a GMP certificate.
Check before applying for a certificate: is your OMS data correct?
When manufacturer’s permits and GMP certificates 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 is the standard since 28 January 2022.
Accordingly, before you submit your application you should check that your data in the (OMS) database is correct.If it is, you can apply for a new or updated manufacturer’s permit and/or a new or updated GMP certificate.These applications should be submitted to Farmatec, the Veterinary Medicinal Products Office, the Medicines Evaluation Board or the EMA, not the IGJ.
This applies to manufacturers, importers and distributors of medicinal products (including veterinary medicinal products) for the European market and the active substances they contain.