Our Exploitant Services

Exploitant

PharmaBlue is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted an early access authorization (EAP previously called ATU) or a marketing authorization (MA).

PharmaBlue holds an “Etablissement Pharmaceutique Exploitant” license from ANSM and as such can take over the organization and supervision of the distribution in France of pharmaceutical products, including advertising, information, pharmacovigilance, batch follow-up, and if required, batch withdrawal operations.

Quality

Review and approval of local artworks for printed packaging components
Handling local product complaints and ensuring appropriate treatment of quality issue which could have an impact on Public Health
Handling of batch recalls (if applicable)
Review of results of Annual Product Quality Review, in close collaboration with the MAH/ATU holder, and assessment made as to whether CAPA or any revalidation should be undertaken
Follow-up of quality of partners (manufacturers, distributors, …): audits, annual review of contract
Monitoring of stock with minimization measures for preventing drug shortage (for essential drugs)

Distribution : Storage & Transport

Compliance with the GDP and French regulation requirements
Ensuring that required storage conditions for products are maintained during transportation and that quality and integrity of products are not compromised
Ensuring appropriate treatment of issue likely to have an impact on Public Health
Monitoring of batches on the French market in collaboration with the distributor (stock situation, returned goods)
Execution of annual mock recall if any real recall occurs during past year

Medical Information

Handling medical information requests with On-call support service 24/7
Reply to healthcare professional and patient questions with client support
Approval of FAQ

Pharmacovigilance

Local contact person for PV (Art.R5121-164)
Management of local PV, i.e. receiving, archiving and following up adverse drug reactions received in France
- Submitting ADR forms to Client PV organization
- Submitting ADRs (ICSRs) to ANSM, if applicable
Supporting local submission of Periodic Safety Update Reports (PBRERs) and other safety documents and ensure compliance with local requirements
Supporting the local implementation of risk minimisation measures

Advertising/Promotional Activities

Review and approval of any promotional materials
Handling a positive list of promotional materials
Manage SmPC updates
Overlooking activities of any medical sales representatives

Exploitant services for MAA product

Case study

PharmaBlue is part of the BlueReg family, an integrated service within the global european regulatory affairs consulting group. PharmaBlue is authorized by ANSM in France as an “Exploitant” establishment…

Read the case