What is a Manufacturing and Import Authorization in pharma?

A Manufacturing and Import Authorization (commonly referred to as MIA) is a type of license used in the pharmaceutical industry. Although a MIA is the official name of the license, some refer to a MIA as a “GMP License”.

When do I need a MIA?

You need a Manufacturing and Import Authorization (MIA) if you meet any of the following two conditions;

• You import medicinal products that are GMP regulated from outside the European Union to the European Union,

• You are a manufacturer of medicinal products inside the European Union.

How do I get a MIA?

Unlike ISO, you cannot “request” a Manufacturing and Import Authorization. There is no company you can invite to perform an inspection against the GMP’s and then certify you.

If you are importing or manufacturing medicinal products you must register your legal entity with your local regulatory authority.

In the Netherlands you must apply your legal entity to Farmatec, which is the licensing authority in the Netherlands for pharmaceutical licenses.

If you are based in other European countries you must apply to your local regulatory authority.

For an extensive list of all the competent authorities in the European Union, go to the website of the European Medicines Agency.

After the application

If you application has been accepted, an inspection of your site will be scheduled. The national regulatory authority will use a risk-based approach when planning inspections. Critical sites will be inspected first. E.g.; manufacturers involved in manufacturing Covid vaccines will be prioritized over manufacturers of other products.

You must ensure you are properly prepared for the regulatory inspection. Verify that you have implemented all the EU GMP requirements as well as any local regulatory requirements.

You must ensure you are properly prepared for the regulatory inspection. Verify that you have implemented all the EU GMP requirements as well as any local regulatory requirements.

For companies outside the European Economic Area (EEA)

If you are a manufacturer of medicinal products outside the European Economic Area and you want to export medicine to the EU you may cannot get a Manufacturing and Import Authorization.

Your importer in the European Economic Area (EEA), is responsible for obtaining a MIA to import your products into the EU. The importer will check your facilities against the EU GMP before importing.

In the case of Active Pharmaceutical Ingredients (API's):

If you pass the importer’s GMP inspection you will be “GMP certified by proxy”. You will most likely not be inspected by an EU regulatory authority, but you will be able to export to the European Union regardless.

In the case of Finished Products (FP):

If you export finished products (meaning: medicines that are not processed further, medicines that go directly to the patient), you will need an EU GMP certificate.

Can I export to the entire EU after being inspected by my importer?

No. Although the importer certifies you as “meeting the EU GMP requirements”, each additional importer will have to perform the same check. If you are inspected by an EU regulatory authority, and you pass the inspection, you will be able to export to all importers in the EU after receiving your GMP certificate.