Importation and distribution
Importation of Biological Investigative Medicinal Products (IMPs) from outside of the EU
Investigational Medicinal Products (IMPs) are substances used for clinical trials, and include placebos and controls, as well as active drugs. When IMPs are to be used in clinical trials inside the EU, various guidelines and directives apply. This means that any IMPs that have been manufactured and/or QC tested outside of the EU must be certified by a Qualified Person (QP) before release. The QP must be named on a licence with an explicit authorisation to import IMPs from outside the EU.
In 2004 we were granted manufacturing authorisation for the manufacture and testing of IMPs following the implementation of Directive 2001/20/EC in the United Kingdom. In 2008, this was extended to include importation of medicinal products, such as gene therapies, biotechnology and recombinant proteins.
This permits us to offer additional services for products from inside and outside of the EU, including:
- Receipt of products
- Cold chain storage
- Quality control testing
- Batch certification
Here at the CBC, we have two Qualified Persons who have authorisation to release products for clinical trial and importation services.
For more information about importation and distribution of IMPs from inside and outside of the EU, including regulatory advice, please contact one of our team.