Services
IMP Services
Import, Export, Storage, Distribution
Three EU Directives, 2003/94/EC, 2001/20/EC and 2005/28/EC, require that investigational medicinal products (IMP) follow the same rules as marketed drugs.
The first Directive lays down the principles of GMP for medicinal products and IMP for human use.
The second Directive details the requirements for implementation of GCP by the member states in the conduct of clinical trials with medicinal products for human use.
The third Directive lays down the principles of GCP for IMP for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, detailing that authorisation for manufacturing, import, export, storage and distribution, is required.
The Benelux office of Harrison Clinical Research is licensed by the Belgian authorities to import, export, store and distribute IMP. This centralised position is ideal for distribution of study medication throughout Europe, significantly reducing customs delays, improving the regulatory permit processes and allowing strict time lines for supply and re-supply to be met.
Transportation to and from our depot is performed by courier companies certified for this purpose, assuring precise tracking and controlling of the IMP from warehouse to the investigational site and back.
The following services are available:
IMP Storage:
- Temperature controlled warehouses
- Controlled environmental chambers
- Room temperature refrigeration (+2 - 8 °C) and freezer storage (-20 °C)
IMP Distribution:
- Throughout Europe
- Ambient, frozen or refrigerated shipping conditions
- Consulting and assistence with import/export licensing
IMP Accountability and Destruction:
- Reconciliation of returned products to the client specifications
QP Release of IMP to European Countries
Feel free to phone us
... straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0
Flyer to download
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