French Public Health Code
In forceThe head pharmacist and the delegate pharmacist(s) of the companies or organisations mentioned in 1° and 2° of article R. 5124-2 must provide evidence of at least two years' practical experience in one or more establishments authorised to manufacture or import medicinal products or products in a Member State of the European Community or a party to the Agreement on the European Economic Area; all or part of this experience may, where applicable, have been acquired during internships beyond the first year in these establishments.
In order to carry out his duties in a company, organisation or establishment involved in the manufacture or import of medicinal products, the pharmacist in charge or the delegated pharmacist must provide evidence that this practical experience includes activities involving the qualitative analysis of medicinal products, the quantitative analysis of active ingredients and the tests and checks necessary to ensure the quality of medicinal products. This practical experience may be considered to have been acquired when the pharmacist in charge or the delegated pharmacist can prove that he has carried out pharmaceutical activities in a pharmaceutical establishment which manufactures medicinal products, enabling him to acquire in-depth theoretical and practical knowledge of the stages of production and laboratory control.
In the companies and their establishments mentioned in 3° of article R. 5124-2, the pharmacist in charge and the delegated pharmacists must provide proof of either the practical experience provided for in the first paragraph, or practical experience of at least two years in a pharmaceutical establishment operating medicinal products for human use, provided that this experience consisted at least of batch monitoring activities associated with pharmacovigilance activities.
For the appointment of the pharmacist in charge and the delegated pharmacists of the pharmaceutical establishments of the central pharmacy of the armed forces or the pharmaceutical establishments of the medical supply establishments of the armed forces health service carrying out import activities, the practical experience involving the exercise of the activities mentioned above within the central pharmacy or the medical supply establishments during the period preceding the granting of the authorisations to open the said pharmaceutical establishments is taken into account.
In the pharmaceutical establishments created within public establishments or non-profit organisations in application of article L. 5124-9-1 in order to carry out activities relating to advanced therapy medicinal products, persons fulfilling the conditions mentioned in article L. 4221-1 providing evidence of at least two years' practical experience acquired in the capacity of person in charge or as person in charge of activities within the meaning of article R. 1243-12 in one or more establishments or organisations authorised under articles L. 1243-2 and L. 4211-8 are considered to meet the conditions of practical experience required to be appointed as pharmacist in charge or acting pharmacist in charge.
The pharmacist in charge of pharmaceutical establishments carrying out the activities of manufacturing and distributing advanced therapy medicinal products must have specific qualifications and work experience in these areas of activity or be assisted by a person who can demonstrate this competence.
