THE STATUS OF “EXPLOITANT” IN FRANCE
In France, a medicine’s access to the market requires that the holder of the market authorisation (MA) or the holder a Temporary Use Authorizations (ATU) also be an “exploitant” or have entered into a contract with an “exploitant”. The “exploitant” is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GDP (Good Distribution Practices) certificate and that is regularly inspected by the ANSM. This status is specific to France.
- Validation of packaging artworks
- Review of Product Quality Review
- Stock monitoring: traceability, out-of-stock prevention, Shortage Management Plan
- Management of complaints & batch recalls
- Regulatory review and filing of advertising materials
- Promotional information
- Strategy and support in drug pricing and reimbursement
- Referencing of the medicine with purchasing platforms (wholesalers, hospitals)
- Registration in pharmaceutical databases (CIP, MVS serialisation, Vidal)
- Monitoring and filing of bids in public tenders
- Recording and processing of medical information requests
- Supply of a Person Responsible for Pharmacovigilance (RPV) and of an on-duty system
- Strategy and support in EAP (ATU) request and dossier
- Review of PTU (Protocol of Therapeutic Use)
- Process implementation & execution :
- Inclusion, orders and database
- FAQ and Medical information
- Batch follow-up, Periodic report, EAP (ATU) renewal
OUR ADDED VALUE
- Tailor-made approach
- Relation with patient advocacy groups
- Close networking with key opinion leaders
- Strong experience in the hospital market
Article R5124-2 of the Public Health Code
3° Exploitant, the company or organisation providing the exploitation of medicinal products other than the experimental medicine, generators, kits, precursors mentioned in paragraph 3 of article L. 4211-1.
Exploitation comprises the wholesale or the free transfer of advertising, of information, of pharmacovigilance, of batch tracing and, where applicable, of their withdrawal, as well as the related storage operations, if any.
The operation is carried out either by the holder of the marketing authorisation mentioned in article L. 5121-8, of the temporary use authorisation mentioned in paragraph a of article L. 5121-12 or of one of the registrations mentioned in articles L. 5121-13 and L. 5121-14-1, by another company or another organisation acting on behalf of the holder, or by both the holder and the other organisation, each carrying out in this case one or more categories of operations constituting the operation of the medicinal product or product.