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?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of GMP product testing laboratories, we can offer a comprehensive testing service portfolio to our customers.
- Standard and custom solutions. If our standard methods do not meet your needs, our skilled technicians can develop customised testing methods tailored to your specific requirements.
If you require more information on our Import Testing services then please contact us.
