GMP inspections and GMP certificates

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).

Certificates automatically extended for a second time until the end of December 2022

Certificates held by medicinal product manufacturers and permit holders are being automatically extended for a second time. The extension is until the end of December 2022. In issuing this extension, the Health and Youth Care Inspectorate is following the policy of the European Medicines Agency (EMA). There are exceptions for certificates with an expiry date specified in the clarifying remarks, and where there are changes in the scope of the GMP/GDP certificate (such as new buildings or new medicinal products). Expectations relating to the extension and other adjustments to the COVID-19 pandemic guidance can be found on the EMA website: Notice to Stakeholders: Questions and answers on Regulatory Expectations for Medicinal Products for Human Use during the COVID-19 Pandemic.

GMP inspections

The principles of GMP are defined in law and described in EU Directive 2003/94/EC. 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 certificate, permit and site clearance

If our finding is that the GMP guidelines are being observed, we issue a GMP certificate. We also 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).

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 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 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.
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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.

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

Before you submit your application, check that the registration in the Organisation Management Service (OMS) database of the European Medicines Agency is correct. From 28 January 2022, this will be required for applications for new or updated permits.

You need to check the data for your organisation (such as the company name and address details) recorded in the OMS. This information is used to issue manufacturer’s permits and GMP certificates in the EudraGMDP database.
For more information, visit: