The status of Responsible Pharmacist in a pharmaceutical company is specific to France and is regulated by the Public Health Code (CSP).
In France, any company with at least one pharmaceutical establishment must be owned by a pharmacist or a company whose management or general management includes a pharmacist (article L5124-2 CSP). These pharmacists are called Pharmacien Responsable (PR).
The Responsible Pharmacist has a statutory position (article R-5124-36 of the CSP) which covers broader responsibilities than those of the Qualified Person (QP) under the current European Union system.
The Responsible Pharmacist (France Qualified Person):
- Organises and supervises all the pharmaceutical operations of the company (article R. 5124-36).
- Is personally responsible for compliance with the provisions relating to his activity (art. L. 5124-2 CSP).
- Exercises his/her profession personally (art. L. 5124-4 CSP) (the PR cannot exercise via a third party company).
- Is an officer of the company with a corporate mandate.
- His entry into function is subject to validation by the French Chamber of Pharmacists..
- His diploma can only be registered for one company or one organisation (art. R. 5124-20).
- Only one Qualified Person is appointed per pharmaceutical establishment.
The Responsible Pharmacist is the privileged interlocutor of the health authorities for all matters concerning the safety of medicines.
The company appoints, at the same time as the Responsible Pharmacist, one or more interim Responsible Pharmacists (art. R. 5124-23 CSP).
Indeed, in case of temporary absence or ban on practising, the Qualified Person must be replaced by an Interim Responsible Pharmacist (Pharmacien Responsable Intérimaire, PRI). This replacement cannot exceed one year (art. R. 5124-22 CSP).
The Qualified Person deputy (QP deputy):
- Replaces the Qualified Person during the latter's absences.
- Has the same powers and attributions as those conferred to the QP during the whole replacement period (art. R. 5124-23 CSP).
- May perform his/her duties as a consultant or employee of the company.
- Does not have a corporate mandate.
His/her entry into function is subject to validation by the French Chamber of Pharmacists.
During the replacement, the Interim Responsible Pharmacist (QP deputy) devotes himself exclusively to this activity (art. R.5124-31 CSP).
The identitý of pharmacists providing replacements, the dates and durations of these replacements are kept in the pharmaceutical establishment for a period of five years (article R 5124-23).
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