The Qualified Person (QP)
a key function in the French pharmaceutical companies
The Qualified Person is a privileged function in France. Placed at the heart of the board of directors of the French pharmaceutical companies, the QP accumulates several responsabilités and is the privileged interlocutor of the Health authorities. The Qualified Person is the guarantor of the respect of the French Health Code (CSP) inside the pharmaceutical company, and more generally, of medicines' safety.
France's Qualified Person role is unique, he has a statutory position that includes larger responsibilities than the ones attributed to European Union's Qualified Persons (Directive 2001/83 EC, article 48 & volume IX).
The French Qualified Person is defined at article R. 5124-34 of the French Health Code (Code de la Santé Publique, CSP). Depending on the type of society in which he performs, he is nominated by the company's Executive board or by the General Assembly and occupies the function of president, general director, deputy CEO or co-managing partner. He organises and surveils every pharmaceutical operation of the company and the persons concerned by those operations (Art. R.5124-36 of the CSP).
One only French Qualified Person is nominated by French pharmaceutical company.
In France the QP can only be the Qualified Person of a single company (Art. R. 5124-20 of the CSP)
A French Qualified Person Deputy (Pharmacien Responsable Intérimaire) must be nominated to replace the French Qualified Person during his absences. The Qualified Person Deputy in France (Pharmacien Responsable Intérimaire) has the same responsibilities that the French Qualified Person during the replacement periods (Art. R. 5124-23 of the CSP).
Activities under the responsibility of the Qualified Person in France
- The manufacture, promotion (publicity and training of the medical sales visit), medical Information, pharmacovigilance, batch follow-up (including the management of complaints, batch recalls, etc.), distribution (including transport conditions), importation and exportation of the concerned medicines, products, objects or articles as well as the correspondent storage operations and labelling operations.
- The French Qualified Person signs the Marketing Autorisation applications (MA) submitted by the company and any other requests related to the pharmaceutical activities.
- The French Qualified Person participates in the preparation of the research and study program.
The French Qualified Person has a social mandate
Every company with at least one pharmaceutical facility must be the property of a pharmacist or of a company in which a pharmacist participates in the company's management or in the general management (Art. L.5124-2 of the CSP).
The French Qualified Person contributes to the decisions of the management bodies, of the administration board, of the direction or of the supervision board of the company, when the deliberations regard or can affect the activities under his responsibility (Art. R.5124-36 of the CSP).
In case he encounters difficulties in fulfilling his missions, the French Qualified Person must inform the other Executive directors of the company of any obstacle or limitation to the exercise of his functions.
In case of disagreement between a management, administration, direction or supervision body and the French Qualified Person on the implementation of the public health rules, the French QP informs the General Director of the French National Agency for Medicines and Health Products (ANSM).
The French Qualified Person is personally responsible
The Qualified Person in France is personally responsible for ensuring the dispositions related to his activities, independently of the aditional eventual company's responsability (Art. L.5124-2 of the CSP).
The French Qualified Person shares the civil and criminal liability with the CEO of the company.
The independence of the French Qualified Person
The French Qualified Person must preserve his liberty of jugement when exercising his functions. He must have, at all circonstances, a behavior compliant to the probity and dignity of the profession (Art. R.4235-3 of the CSP).
The Qualified Person in France
|Administration|| Background and liability||Onsite presence|
|Is nominated by the company's administration board|| |
Shares the legal liability with the General Director/President of the pharmaceutical company
|Must be permanently physically present at the company|
|Has a «social mandate»|| |
His missions concern the activities related to the public health and to the general activities of the company
|During his absences, he is replaced by the French Qualified Person Deputy (Pharmacien Responsable Intérimaire)|
|Takes part in the company's administration board|| |
Must preserve his liberty of jugement in the exercice of his functions
| Justifies of a practical experience of 6 months in QC (for manufacturers and importers) or in activities of batch follow-up associated with pharmacovigilance activities (for "exploitant" companies)|
Diploma and experience of the French Qualified Person
The French Qualified Persons are submit to the validation of their career by the French Council of Pharmacists before they can assume a QP role in a French pharmaceutical company.
To be a French Qualified person the following is requested:
- an European diploma of pharmacy or a recognized diploma from a third country
- speak French fluently
- 6 months of practical experience in Quality Control (for a cursus of 6 years of pharmacy) - for companies with at least one manufacturing actitvity or importers
- 6 months of practical experience in pharmacovigilance and batch follow-up - for companies with only the activities of "exploitant pharmaceutical site".