Eurofins BioPharma Product Testing Netherlands (“EBPT-NL”) is an expert in import testing of Drug Products (Finished Dosage Forms, FDF) into the European Union (EU). We have our own Qualified Persons (QP’s) and can also assist with any of 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.
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.
MoH of Lebanon Registration
Are you planning to launch a pharmaceutical product in Lebanon and do you require a WHO-prequalified laboratory that can provide a Certificate of Analysis (CoA) valid in that country?
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.
If you require more information on our Import Testing services then please contact us.