EU batch release of import products from non-EU countries

In June 2022 our pharmacy experts at the WESSLING branch in Münster released the first batch of a medicinal product imported from a third country for the European market. This was a product manufactured outside the EU and imported into the EU. Our in-house QP (Qualified Person) provided it with the necessary batch certification or EU release.

EU batch certification and EU release of imported products by QP

Each batch of investigational medicinal products or authorised medicinal products used in the European Union must be certified and released by a QP to be placed on the market.

In the case of EU imports, if the batch was produced in a third country, i.e., non-EU country with which no mutual recognition agreement exists, it first arrives at the permanent establishment of actual import. From there, delivery to customers can only take place after certification by a QP stating that the batch was produced in accordance with the relevant EU legislation.

In addition, a quality control test, the so-called EU Retest, must be conducted before imported products are certified.

Thanks to the expertise and qualifications of our pharmaceutical specialists, we can provide our customers with all these services from a single source.

Our services include in detail:

  • Supply chain qualification and audit
  • EU Retest and preparation of the Certificate of Analysis (CoA)
  • Preparation of the QP declaration for active substances required for EU approval
  • QP batch release of finished medicinal products in compliance with GMP

Your contact to our pharmaceutical experts

© WESSLING - Maik Siebelmann
„We are here for you to fulfil the process of manufacturing and testing GMP compliant products. Please do not hesitate to contact us to discuss your needs!“