EU Import Testing
Are you planning to import you pharmaceutical product into the European Union (EU)? EU-Import testing is a mandatory requirement for each batch of drug product (finished dosage form, FDF) manufactured outside the EU. The required tests need to be performed in a laboratory that is physically located inside the EU. Eurofins Sinensis routinely performs these tests for customers mainly based in Asia and is therefore your ideal pharma Europe (pharma EU) partner.
Mandatory EU-importing requirements
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
QP Release of your product
In order to comply to the previous requirements, in general two models are used:
- Eurofins Sinensis performs the analyses and delivers a Certificate of Analysis (CoA) to the company that does the market release of the product using its own Qualified Person (QP).
- Eurofins Sinensis performs the analyses as well as the batch certification (QP release).
Eurofins Sinensis has several QP’s available for these services. Please contact us to discuss your specific requirements.
Saving time? Eurofins Sinensis offers logistic assistance
Located between Rotterdam Harbor and Amsterdam (Schiphol) Airport Eurofins Sinensis can advise in time-saving schedules and the regulatory requirements for these, such as transport validation.
As Eurofins Sinensis works with many parties in the EU and in Asia, it is also able to help you with finding business partners in both geographical regions.
- Extensive service portfolio. Eurofins Sinensis can be your one-stop-shop, providing a single-point-of-contact in your development process.
- Business partners in the EU and Asia. Over the years Eurofins Sinensis delivered its services to many companies worldwide. We share this network with our customers, allowing to them find new business partners.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- One Certificate of Analysis will be issued with results of all performed analysis (both chemical and microbiological).