2nd Quarterly Update 2006
Investigational medicinal products (IMP’s) are on the agenda these months as we are to take care of the regulatory details of two such products. For an ophthalmological product we are co-writing parts of the Investigational Medicinal Product Dossier (IMPD). A second project includes a new radiopharmaceutical compound for which we have to comment on the supply chain. In addition we will support the manufacturing company with the application for a pharmaceutical manufacturing license. As you may know, IMP’s are subject to GMP-regulations as much as regular medicinal products, requiring such a license as well as the appointment of a Qualified Person to release the batches.
Speaking of supply chains, the use of direct-to-patient (DtP) distribution of medicinal products has grown steadily over the years. This type if distribution delivers medicinal products from a wholesaler directly to patients at home without the interference of their community pharmacy. Especially cold-chain biotechnological products are under consideration for this type of distribution and a number of wholesalers are now offering this service to pharmaceutical companies. One of these companies has asked to profile these suppliers, enabling them to set up such a DtP-service for one of their products.
A third project requiring much attention this quarter, refers to the transfer of the production of a Type II medical device from one company to another company abroad. Moreover, it is not just a simple transfer, but some design changes are incorporated in the transfer project. This requires adaptation and extension of the Technical File to reflect these new manufacturing details as well as the new design. And, last but not least, this all needs the final blessing of the Notified Body for which purpose audits have been scheduled in late June, early July. We expect to finalize this project prior to the European Summer Holiday in August.
