EU Batch Release

Import and release of medicines within the European Union. 

Need help? Choose the European Pharma Hub Team!

With more than 20 years of experience in the pharmaceutical industry behind us, we know what you need! We can help you with the following import and EU release processes with our cost-effective solutions:

  • Comprehensive service for the import, laboratory testing and release of pharmaceutical products from third countries to the EU.
  • Based on GMP and GDP license, QP service, quality assurance consulting, audit of finished product manufacturers, API manufacturers.
  • Re-examination of production batches, verification of the conformity of supply chains.
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Every batch of investigational or market authorized medicinal product used in the European Union has to be certified and released by a QP. 

Delivery to customers takes only place after our QP has certified that every production batch has been produced and controlled in accordance with the relevant EU legal requirements.

Any other EU regulations relevant to the production, control and release of medicinal products.

This certification process including the EU Batch Release and it applies to medicinal products imported from outside the European Union as well as batches that undergo labeling and packaging procedures in house.

It assures that the quality of all our shipments complies with the highest possible EU quality requirements.

 

Detailed listing of our Qualified Person (QP) services

  • Qualification of the supply chain and audit (if required)
  • Definition of testing scope and release specification for the European Union
  • Review of manufacturing and testing records, checking for compliance with EU-GMP Guidelines and with the Product Specification File
  • Import into EU (via Hungary)
  • Receipt of the medication, incoming inspection, storage under quarantine
  • Sampling and batch reanalysis (if required)
  • Release decision
  • CoA (Certification of Analysis), CoC (Certification of Compliance) with EU-GMP Guidelines
  • Archiving of retained samples and documentation
Contact us
  • +36 30 403 1558
  • [email protected]
  • 2360 Gyál, Gorcsev Iván u. 5. Hungary (Akácliget Logisztikai Központ 15-16. kapu).

The European Pharma Hub is committed to the development of high-level services that help steadily expanding its range of partners.

Our premise is located close to Budapest. We received all relevant certificates from the Hungarian Authorities and our activities strictly follow EU GMP/GDP. Our manufacturing site has maintenance on own Quality Management System with ISO 9001 certificate. Also our Global Pharmaceutical Partners do successful audits at our site.

 

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