Exploitant Services at the time of the EAP launch
The Exploitant services provided by Pharma Blue include the organization and supervision of the pharmaceutical operations in France as described in art R 5124-36 of the Public Health Code and more particularly, in the context of a cohort ATU:
- Support the ATU holder for the communication with ANSM and CEPS
- Check compliance of products sold on the French market with French regulation & ATU including batch follow-up. Respond to pharmacists about their orders and follow-up with distributor/transporter.
- Local contact person for PV (Art.R5121-164) and management of local Pharmacovigilance (PV) in line with the French regulations, i.e. receiving, archiving and following up adverse drug reactions received in France as required by local regulations, guidelines, and applicable SOPs, and submitting ADR forms to ATU holder and its EU organization for PV
- Handle local product complaints and batch recalls, i.e. ensuring management of product complaints and recall of products distributed in France in line with French regulation
- Review and approve artworks and printed packaging components
- In close collaboration with the manufacturer, the distributor of the product in France and ATU holder, ensure products are distributed according to conditions ensuring appropriate storage, transportation, security and integrity, ensure appropriate treatment of issue likely to have an impact on public health (Art.R5124-55), ensure compliance of the product distribution with the GDP and regulation requirements within the French territories, monitoring of batches on the French market. Conduct audits of the different stakeholders.
- Handle medical information requests with On-call support service 24/7 and reply to healthcare professional and patient questions