Trial medication service
Import and release of IMPs
CardioSec holds a Manufacturing and Import Authorisation (MIA) according to 2001/83/EC,
enabling us to import, label and release Investigational Medicinal Products.
Since our MIA is not limited to certain products or trial projekts, we are able to import on very short notice
IMPs and other medicinal products for use in trials like rescue medication e.c. via Germany into all EU member states
plus Norwegian and Liechtenstein.
Our services in this field includes:
- QP decclaration for submission of CTA
- Audits of manufacturing sites
- Transport of products from overseas and customs clarification
- Storage and distribution to clinical sites
- Labeling and release of products