GMP
Obtain your GMP licence (Manufacturer's Licence/MIA) with expert guidance from Rooijen Consultancy.
Van Rooijen Consultancy assists companies in obtaining a Manufacturing Authorisation, also known as a GMP licence or Manufacturer's/Importer's Authorisation (MIA). This licence is mandatory for companies that manufacture or import medicinal products within the European Union. We support you every step of the way, from application to inspection, ensuring that your organisation fully complies with EU GMP regulations.
When do you need a GMP licence?
Your company requires a GMP licence if you manufacture medicinal products within the European Union and/or import medicinal products from outside the EU into the EU. A GDP licence is generally required for distribution within the EU or export outside the EU.
How we help you obtain a GMP licence
Unlike certifications such as ISO, a GMP licence cannot be purchased. It is only granted by the competent government authority in the EU country where your company is based.
We help you with
- Determining whether a GMP licence (MIA) is required
- Preparing internal processes, documentation and quality systems
- Submission of the application to the competent authority (e.g. Farmatec in the Netherlands)
- Preparing for the inspection by the supervisory authority (e.g. IGJ)
- Comply with all EU GMP guidelines and national legislation
In the Netherlands, Farmatec is responsible for issuing licences. In other EU countries, you must submit your application to the local regulatory authority.
After submitting the application
Once your application has been accepted, an inspection of your site will be scheduled. The regulator uses a risk-based approach for this: sites with a higher risk are inspected as a priority. In the Netherlands, the inspection is carried out by the Health and Youth Care Inspectorate (IGJ). You must fully prepare your site for this inspection in accordance with EU-GMP and national guidelines.
For companies outside the European Economic Area (EEA)
If your company is located outside the EEA, you cannot obtain a GMP licence (MIA). Instead, your importer within the EEA must apply for the licence and inspect your facility for compliance with EU GMP.
For APIs (active ingredients): If you pass the importer's audit, you may supply this party.
For finished products (FP): You need an EU GMP certificate to be able to export to the EU.
Please note: If you have been approved by one importer, you are not automatically allowed to supply other importers in the EU. Only an inspection by an EU authority will result in a GMP certificate that is recognised throughout the EU.
SERVICES
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