EU Product Release
Under European Union legislation, all products manufactured outside the EU or states without mutual recognition, must have release quality control testing performed by an EU located GMP certified lab upon import into the European market.
This testing, combined with the appropriate assessments of the related quality documentation and systems of the manufacturer by a European Qualified Person (QP), enables products to be released and distributed on the EU market.
This applies to both finished medicinal products and IMPs (Investigational Medicinal Products) that are to be placed on the EU market from third countries (1).
Clients with the intention to enter or increase their product portfolio on the EU market can rely on the support of Eurofins laboratories from the beginning utilising our vast and diverse release testing capabilities, method transfer expertise, experienced Qualified Persons and auditing competence. Furthermore, with the help of our established partnerships we can also assist from physical importation to distribution to wholesalers.
We have been supporting our clients global supply chains and entry into the EU for over 20 years from our facilities in the European Union.
Why Choose Eurofins BioPharma Product for Testing?
Eurofins BioPharma Product Testing state-of- the-art global facilities offer extensive laboratory capacity and the highest level of instrument technology, enabling our facilities to become an extension of your own operation.
Our flexible operating systems allow timely testing and reporting of your results to expedite market entry. One of our dedicated client service representatives will monitor and report progress on your release.
Our 25-year history of cGMP compliance ensures you will receive the highest quality data. We meet your global reporting needs with data that is generated in full compliance with the European Medicines Agency.
We work extensively with many of the world’s leading global biopharma companies in this area and have established relationships with logistics organisations, importers and QPs.
Comprehensive European Product Release Services
In house
- Setup of work, data and product flow from non-EU manufacturer to EU wholesaler
- Support for the importation process: authorisations (2), custom clearance, warehousing
- Analytical Method Transfer, testing and release of:
- Sterile and non-sterile products
- Small molecule drug products
- Biologics
- Generics
- Finished products & IMPs
- Products for human & veterinary use
- Special dosage forms such as transdermal patches
- Evaluation of documentation & generation of certificates by our Qualified Persons:
- API declaration for the submission of New Product Application
- Compliance dossier evaluation
- Batch documentation check including reviewing shipping documents and transport conditions
- Batch certification for EU markets
- CoA (Certificates of Analysis) - issued through LIMS in compliance with EU GMP Annex 11 and the latest requirements on audit trail and data integrity
- Investigation of root causes of OOS analytical results
- Management of change control, deviations and CAPAs
- Annual Product Quality Review
- Consultation support for European Quality Assurance Compliance
- Auditing of manufacturing sites (3)
- Support to create or improve QA systems (3)
Contracted partners
- Storage of products and reference samples
- Custom packaging solutions
- Repackaging
- DayOne Launches of generics (day 1 after patent expiry)
(1) Several third countries are exempted from the EU retesting obligation by Mutual Recognition Agreement (MRA). There are: Australia, Israel, Japan, Canada, New Zealand, Switzerland and the US.
(2) Eurofins BioPharma Product Testing holds an importation permit for analytical samples, and an importation permit for commercial products.
(3) Eurofins, through the Healthcare Assurance business line, offers GMP audits to ensure compliance with internationally recognised standards and market requirements. The auditing process is impartial and fully independent from testing.
Contact: EUreleasetesting@eurofins.com
