The Chief Pharmaceutical Officer also called Responsible Pharmacist (RP) is a key role , essential to the organization of any pharmaceutical laboratory involved in the manufacture, exploitation and distribution of medicinal products for human use in France.
The Chief Pharmaceutical Officer ensures the quality of the medicine and the safety of the patients. Their position, functions, and assignements are defined by the regulations. Their skills are validated by their peers based on practical experience. Their responsibilities are numerous. They must maintain their freedom of judgment and hold pharmaceutical authority within their structure. They can delegate some activities and must be replaced in case of absence.
Positions, functions and Assignements
The Chief Pharmaceutical Officer has a statutory position within a pharmaceutical establishment (manufacturer, operator, depositary or wholesaler-distributor).
They organize and supervise all pharmaceutical activities: manufacturing and batch release, advertising, information, pharmacovigilance, follow up and withdrawal of batches, distribution, import and export, storage and transport.
The responsibilities attributed to the RP are broader than those of the qualified person within the European Union (directive 2001/83/EC, article 48). They have a personal responsibility for all pharmaceutical activities, unlike the qualified person who exercises operational responsibility for the activities they are responsible for (batch release, follow up and recall of batches, pharmacovigilance).
Their status as well as their functions and assignements are defined in the Public Health Code (Code de la Santé Publique CSP) in articles R.5124-16 to R.5124-41.
Validation of Skills and Practical Experience
Their skills and practical experience are validated by the National Council of the Order of Pharmacists. Decree No. 2022-324 of March 4, 2022, recently modified the terms of the practical experience required for the RP (CSP Articles R.5124-16 à R.5124-18).
The RP is appointed by the competent corporate body of the company and then declares themselves to the competent authority: the ANSM*.
The Responsibilities of the RP
The responsibilities of the RP are of three types:
- Legal and criminal liability
- They are a member of the management of the company.
- They are the main contact of the Health Authorities.
- They arepersonally responsible for the compliance of the pharmaceutical establishment with the Public Health Code.
- Disciplinary responsibility
- Respect for professional ethics
- Compliance with their deontologic obligations
- Civil liability
The RP shares civil and criminal liability with the manager(s) of the company.
Freedom of Judgment and Pharmaceutical Authority
Like any pharmacist, the RP preserves their freedom of professional judgment in the exercise of theirfunctions (CSP Article R.4235-3).
They have authority over all pharmaceutical staff (CSP Article R.5124-36) and appoints the delegate pharmacist(s).
Delegation and Replacement
The RP can delegate some pharmaceutical activities. The delegate pharmacist is bound, within the limits of their delegation, to the same obligations as the RP (CSP Article R.4235-68).
In the event of absence, the RP is replaced by an interim responsible pharmacist (CSP Article R.4235-70). The IRP then has the same functions, assignements, and responsibilities as the RP during the replacement period.
ATESSIA supports Chief Pharmaceutical Officer in the performance of their duties: regulatory intelligence, CMC support, advertising, pharmacovigilance, activities related to regulatory affairs and quality assurance, and offers Interim Responsible Pharmacists registered at the Pharmacists Council.
Article written by Christelle PETIT, Pharmaceutical Affairs Advisor and Director.
*ANSM : Agence Nationale de Sécurité du Médicament et des produits de santé (competent authority for medicines and health products)