Celerion Receives License Enabling Investigational Medicinal Products to be Imported Directly to their GMP-Licensed Facility

September 7, 2011

Company News Release

Celerion announced that its clinical research operations in Belfast, Northern Ireland UK, have received authorization from their competent authority, the Medicines and Healthcare product Regulatory Agency (MHRA) to have importation of IMPs added to their manufacturing (MIA(IMP)) license. The addition to the license enables the elimination of a third party vendor to import IMPs on behalf of Celerion thereby saving time, cost, and initiating direct communication with clients to expedite early stage clinical studies.

The import license gives Celerion’s facility in Belfast the ability to import investigational products from outside the European Economic Area when manufacturing standards from the exporting country have been confirmed as equivalent to the standards required by European legislation.

“The addition of the import license was based on client demand and continues to demonstrate the high quality work and experience at Celerion,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “This import license underpins Celerion’s commitment to a global clinical strategy and reduces the lead time from study concept to first dosing. Clients also benefit from reduced costs by eliminating third party storage and transport prior to certification of the product.”