Regulatory Affairs
- Taking responsibility for contact with the Health Authorities
- Request for import and export licences
Import Operations
According to the contract established between Theradis Pharma and the sponsor of a clinical trial, the importation of IMP concerns all countries listed below and can concern an unpackaged product, partially opened or finished.
Outside the EEC (free exchange zone), the products imported by Theradis Pharma could also come from all countries corresponding to the following different zones :
European countries outside the EEC
Other geographical areas :
- North America
- Central America
- South America
- Australia
- Africa
- Asia
At the moment of the reception of the batch of products, a control of the delivery and the associated required documents relating to the production of the products is carried out.
A sample is taken and sent to an approved analytical subcontractor for control (if required)
Certification of the batch by the Theradis Pharma Qualified Person (Pharmacist), according to the different documents supplied by the manufacturer, as well as all elements proving that the batch was fabricated according to the standards and regulations in force.
All documentation relative to the imported batch is archived according to the regulations in force.