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Manufacturers in Third Countries

Manufacturers in Third Countries

Exporting medicinal products to the European Union from third countries

Third countries are countries that are not in the European Economic Area (EEA). If you are a manufacturer of medicinal products and you want to export your products to the European Union you don’t need an GMP certificate, We will explain the possibilities for exporting pharmaceutical products to the EU from third-countries.

Pharmaceuticals in the European Union

Manufacturers, importers and distributors of pharmaceutical products in the European Union have to abide by the EudraLex Volume IV regulatory requirements. These requirements are set by the European Union, before they are adopted by Member States.

The European Commission issues directives. A directive is the “law”. These directives (or laws) are extremely high-level documents. They require interpretation. The EudraLex GMP and GDP guidelines are an interpretation of the directive.

Manufacturers, importers & distributors have to have the following licenses and certificates to be able to operate in the European Union:

Pharmaceuticals entering the European Union

Medicinal products entering the European Union must be imported by an importer with a Manufacturing and Import Authorization (MIA).

The importer is a registered legal entity, which has a MIA and a GMP certificate. The importer has been inspected against the EU GMP by it’s national regulatory authority.

The importer is a registered legal entity, which has a MIA and a GMP certificate. The importer has been inspected against the EU GMP by it’s national regulatory authority (competent authority).

Your importer will perform an EU GMP inspection of your facilities and Pharmaceutical Quality System before your product can be exported to the European Union.

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 your importer in the European Union regardless.

The QP Declaration

The Qualified Person Declaration (QP Declaration) is the unofficial term for the approval given by your importer after it’s EU GMP inspection at your site.

The QP declaration does not have a standardized format, it is a formal document provided by your importer stating that you are in compliance with the EU GMP.

After receiving the QP declaration, you may export your products to the importer. For every new importer the process will be repeated. For every new importer an inspection will be performed, and – if you are in compliance – a QP declaration will be issued by the new importer.

The QP declaration is not equal to an EU GMP certificate. It does not allow you to export to the entirety of the European Union.

The EU GMP certificate

There are thousands of pharmaceutical companies in the world. Competent authorities do not have the capacity to check all the pharmaceutical and biotech companies exporting to the EU – on-site for 1 to 3 days. The toll on the inspectors and their capacity would be too high.

To cope with this capacity issue, the European Union likes to restrict their inspections of companies outside the EU to a minimum.

Each year the risks in the pharmaceutical supply chain are assessed by the competent authorities. If a company is deemed a high risk because:

  • It is the only company producing a medicine or essential ingredient,
  • It produces products for patients that already have a severly weakened immune system (oncology, transfusion products, etc.),
  • There has been a recent serious issue with quality,
  • There has been a serious disruption in the supply of medicine from the manufacturer,
  • It produces a relatively “new” product (e.g. IMP’s / ATMP’s).

The competent authority may decide to inspect that company against the EU GMP. In that case, after passing the inspection, an EU GMP certificate will be issued to the inspected company.

Companies in third-countries must therefore regard an EU GMP certificate as a “bonus”, not a necessity. The only necessity to be able to export to the European Union is approval by the importer (the QP declaration).

Jaap Koster
Jaap Koster

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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