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BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR Tel +44 (0)771 897 1245   email enquiries@biochem-qp.com
IMP Importation for EU Clinical Trials Your product’s gateway to Europe
Investigational Medicinal Products Products for use in clinical trials are termed IMPs (Investigational Medicinal Products) in the EU Good Manufacturing Practice guidelines - the term also applies to placebos and comparator products, as well as the active drug.   Getting IMPs manufactured in Third Countries into Europe Any IMP batch that has been manufactured or QC tested in a so-called ‘third country’ (i.e. a country outside the European Economic Area - coloured blue / green above), must be certified by a Qualified Person before it can be used in a European clinical trial. The QP has to be named on a manufacturer’s licence within the EEA, with specific authorisation to import IMPs from outside Europe.   When you submit an application to conduct a clinical trial in Europe, you will need to name an EEA-based importation site from where the imported product will be released for onward distribution within the EEA The QP at the importation site will need to provide a declaration of EU GMP compliance for all 3rd country IMP manufacturing and testing sites, which must be submitted along with the CTA (Clinical Trial Application) before you can start your trial. We will perform the necessary audits of third country manufacturing and QC sites to provide the QP declaration for your CTA We will import your IMP batches into Biostore UK’s MHRA-approved state of the art controlled temperature storage facility in Scotland, with unrivalled expertise in cold-chain storage (including liquid nitrogen and -70C). Once QP certified by us, the IMP batch can move freely to any of your designated distribution centres within Europe We can also identify preferred partners for cold-chain shipping, IMP re-labelling (including expiry updates), and clinical site distribution
Supply chain Risk Assessment
Third Country site audits against EU GMP
Liaison with clinical trial sites
QP Declarations for IMPs manufactured / tested in Third Countries
Selection of couriers / distrubution facilities
QP certification and batch release of IMPs into Europe
IMPD authoring / reviews
Controlled temperature storage, including ultracold
compliance through science
Specialists for sterile / biological IMPs from USA
IMP Importation