The French Responsible Pharmacist - A key role in the French Exploitant

The role of the Responsible Pharmacist is often underestimated or misunderstood. However, in France, it is an essential regulatory pillar for accessing and maintaining medicines on the market.

The Responsible Pharmacist's role is not limited to regulatory supervision: he or she is responsible for ensuring the compliance, quality and safety of medicines throughout their life cycle on the French market.

What is an Exploitant in France ?

• It is a legal entity responsible for placing a medicinal product on the French market.
• It is a unique status that only applies to the French market.
• The Exploitant must be located in France and must have an authorisation granted by the ANSM (WDA = Wholesale Distributor Authorisation).
• The Exploitant is the point of contact between the MAH, the wholesalers, the hospitals, the healthcare professionals, the regulators, the payers and the health authorities.
• The Exploitant requires to have a responsible pharmacist (qualified person) in house who is responsible for the activities.
• The MAH holder may be an Exploitant itself or outsource it to a service provider or a partner.

Responsible Pharmacist Role

In France, the role of the Responsible Pharmacist is governed by a stringent regulatory framework, defined by both European regulations and the Public Health Code (CSP).

The Responsible Pharmacist is:

• a qualified pharmacist,
• registered with the Order of Pharmacists (Section B),
• officially appointed to the ANSM by the Exploitant.

He or she is legally and personally responsible for all pharmaceutical operations carried out by the Exploitant for medicines placed on the French market, including when these activities are subcontracted to partners or service providers.

• Ultimate responsibility remains with the Responsible Pharmacist

He is responsible for Distribution in France (WDA Authorisation), even if operations are carried out (=sub-processed) by CLINIGEN Ltd or another entity.

With additional responsibilities for France:

• Advertising/Promotion,
• Medical information,
• Pharmacovigilance, …

These activities are considered to be "pharmaceutical operations" and are the responsibility of the Responsible Pharmacist.

The Exploitant/ Responsible Pharmacist is responsible for all aspects of the product it places on the French market.

Appointment of an Responsible Pharmacist Deputy (PRI) is mandatory; the PRI assumes all Responsible Pharmacist responsibilities during any absence.

Responsible Pharmacist Responsibilities

The Responsible Pharmacist:

• assumes professional responsibility,
• may be held disciplinarily responsible before the Order of Pharmacists,
• may be held personally criminally liable in the event of serious misconduct.

This responsibility applies to:

• products,
• processes,
• partners,
• and the overall compliance of the Exploitant’s activity in France.

Focus on quality Activities

From a GDP and GMP point of view :

QTA should be in place between Exploitant and MAH : Distribution in France under the responsibility of Exploitant & the Responsible Pharmacist.

• Batch follow-up : customer qualification, customer service, returns, …
• Shortage management.
• Transports and carriers.
• Artwork Final Proof.
• PQC management : Receipt, triage, local record for traceability purpose, requirement to perform initial and final criticality of the complaint, reconciliations.
• Involved in the Product Quality Review performed by the Manufacturer and the Holder of the product.
  • Oversight of France of the Exploitant with support from Clinigen.

Focus on Pharmacovigilance activities

SDEA should be in place between Exploitant and MAH.

The Exploitant should be integrated in the Pharmacovigilance System Master File (PSMF) of the Client.

The Exploitant provides to the Holder of the Product a Responsible Person for PV (RPV).

The Local PV tasks under the Responsibility of the Exploitant & Responsible Pharmacist are :

• Receipt, triage, locally record for traceability purpose, translation when necessary and forward to client and reconciliation.
• Review of local French literature (sub-contracted to a service provider).

Focus on Medical Information activities

The Exploitant & Responsible Pharmacist is responsible for Medical Information in France.

The Local MI tasks under the Responsibility of the Exploitant & Responsible Pharmacist are :

• Receipt, triage, locally record for traceability purpose, translation when necessary and forward to client and reconciliation.
• If Q&A provided by client : answer to inquiries based on Q&A, monthly report.
• Preparation of custom responses for questions not available in standard responses or FAQ document, where available.
• French answer to all enquires.

Risks and impacts in the event of non-compliance

In France, any regulatory non-compliance related to the Exploitant’s activities directly engages the responsibility of the Responsible Pharmacist and may have major consequences for both the Exploitant and the MAH.

Clinigen Healthcare France

Julie Donjon – Responsible Pharmacist            Annabelle Perret – Responsible Pharmacist Deputy