We have our own Qualified Persons (QP’s) and we can also assist with our logistic support services or other activities available in our service portfolio. As some of the EBPT-NL laboratories are WHO-prequalified they have a specific license from the Ministry of Health (MoH) of Lebanon for clients that seek registration in this country. More information is provided below.
EU-Import Testing
Are you planning to import a (bio)pharmaceutical drug product into the European Union (EU)?
EU-Import Testing is a mandatory requirement for each FDF batch that is manufactured outside the EU. The required tests need to be performed in a laboratory that is physically located inside the EU.
Mandatory requirements for batch certification are detailed in Annex 16 of the EU Guide to Good Manufacturing Practice and comprise:
- Compliance of the batch and its manufacturing with the marketing authorization;
- Assurance that manufacturing has been carried out compliant with EU-GMP;
- Validation of manufacturing and testing processes (through audits);
- Review of deviations and changes in production and quality control;
- Batch record review for completeness, integrity and compliance.
In order to comply with the previous requirements, in general two models are used:
- EBPT-NL performs the analyses and delivers a Certificate of Analysis (CoA) to the company that does the market release of the product using its own QP; or
- EBPT-NL performs the analyses as well as the batch certification (QP Release).
Conveniently located between the port of Rotterdam and the airport of Amsterdam (Schiphol) EBPT-NL can advise in time-saving schedules and the regulatory requirements for these, such as transport validation.
EBPT-NL is your ideal partner and facilitates your product launch as it is WHO prequalified. If you require a quotation please send us the analytical methods and corresponding specifications, obviously after having agreed on and signed a confidential disclosure agreement.
Why choose Eurofins BioPharma Product Testing Netherlands
- Business partners in the EU and Asia. Over the years Eurofins BioPharma Product Testing Netherlands delivered its services to many companies worldwide. We share this network with our customers, allowing to them find new business partners.
- Extensive service portfolio. Eurofins BioPharma Product Testing Netherlands can be your one-stop-shop, providing a single-point-of-contact in your development process. Read more about our services.
- One Certificate of Analysis will be issued with results of all performed analysis (both chemical and microbiological).
If you require more information on our Import Testing services then please contact us.
