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GMP inspections outside Europe

European rules apply to the manufacture of medicinal products entering the European market. These rules are contained in the Good Manufacturing Practice (GMP) guidelines. Medicinal products may be manufactured in factories outside the European Economic Area (EEA), but European rules still apply. That is why the Health and Youth Care Inspectorate (IGJ) conducts inspections of factories outside the EEA.

This information is mainly intended for manufacturers and authorisation holders who want to request an inspection outside the EEA.

Requesting an inspection outside the EEA

You can request an inspection if you meet the conditions below. Please note that these conditions apply to national registration procedures. If the product is to be registered through the Central Procedure, please check below at 'Registration through the Central Procedure'.

Conditions

  1. The company with manufacturing authorisation responsible for releasing the medicinal product to the European market is based in the Netherlands.
  2. The registration authority has confirmed a time slot for processing the registration application (only for new registration applications).
  3. A quality agreement is in place between the non-EEA medicinal product manufacturer and the Dutch manufacturing authorisation holder responsible for the release.
  4. A successful audit has been conducted by or on behalf of the manufacturing authorisation holder at the non-EEA medicinal product manufacturer, as described in Chapter 7 and Annex 16 of the GMP guidelines.
  5. The factory outside the EEA is located in an area to which our inspectors can safely travel (see the note under 'Security Situation').


If you meet these conditions, you can submit the request through our Information and Notification Centre; see Contact. Here, you can also read how to send information and documents securely. Your message must contain the following information:

  • name and address of the non-EEA manufacturer;
  • product name, strength and dosage form of the medicinal product 
  • name and address of the company with manufacturing authorisation releasing the medicinal product after importation. If these are multiple companies, list all of them; 
  • confirmation that the necessary signed quality agreement is in place.


Please attach the following documents:

  • the report of the audit conducted at the non-EEA manufacturer;
  • the confirmed time slot of the registration authority (only for new applications);
  • the page from the registration dossier listing all the companies responsible for releasing the medicinal product (in the case of registered medicinal products).

Registration through the Central Procedure

If you apply for registration through the EMA's Central Procedure, there is no need to request an inspection with the IGJ. The Committee for Medicinal Products for Human Use (CHMP) decides whether a GMP inspection is needed at medicinal product factories outside the EEA. The CHMP is the EMA’s medicinal product evaluation committee. The EMA also coordinates the inspection to be conducted and submits a corresponding request to the IGJ or another European authority.

Scheduling of inspections

We schedule inspections based on an assessment of risks. We also schedule foreign inspections well in advance. This means, that after receiving a request, we cannot immediately indicate, when the GMP inspection will take place. The non-EEA manufacturer will be notified about three months before an inspection. In the period between the request for an inspection and our notification, we regrettably cannot provide information about our schedule.

Successful inspection

After the inspection, the inspected company will receive a draft report in English with our findings. The company can then respond to this draft report. If necessary, we will review a plan of action if we have requested such a plan. We then adopt the final report. If we find that the manufacturer complies with the European GMP guidelines, we issue a GMP certificate. The certificates are valid in all EEA countries and can be found in the EudraGMDP database.

Follow-up inspections

If the IGJ has previously conducted an inspection, requesting a follow-up inspection is not necessary. For centrally registered products, the EMA will submit a request to us to conduct a new inspection. For nationally registered products, we schedule follow-up inspections. Manufacturers will be notified of the date of the next inspection before their GMP certificate expires.

Security situation

In some situations, our inspectors cannot carry out foreign inspections. For example, during national or international crises, if there are travel restrictions or health risks, or when other restrictions apply in a country. We follow the Ministry of Foreign Affairs’ travel advice in such cases.

Costs

There are costs associated with a GMP inspection, including the travel and accommodation costs of the inspection team. Other costs depend on the medicinal product's registration procedure.