Subsection 2: Duties and powers of the pharmacists responsible.

With a view to applying the rules laid down in the interests of public health, the pharmacist in charge defined in article R. 5124-34 assumes the following duties insofar as they correspond to the activities of the company or organisation in which he works:

1° He organises and supervises all the pharmaceutical operations of the company or organisation, and in particular the manufacture, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of the medicinal products, products, objects or articles concerned, as well as the corresponding storage operations;

2° It ensures that transport conditions guarantee the proper conservation, integrity and safety of these medicinal products, products, objects or articles;

3° After examining the dossier, he/she signs the marketing authorisation applications submitted by the company or organisation and any other application relating to the activities he/she organises and supervises;

4° He/she takes part in drawing up the research and study programme;

5° It has authority over the delegate and assistant pharmacists; it approves their recruitment and is consulted on their dismissal, except in the case of an army chemist pharmacist;

6° It appoints interim delegate pharmacists;

7° It informs the other managers of the company or organisation of any obstacle or limitation to the exercise of these powers;

8° He implements all the necessary means to ensure compliance with the obligations set out in articles R. 5124-48 and R. 5124-48-1 ;

9° It shall ensure, in the case of medicinal products intended to be placed on the market in the European Union, that the safety features referred to in Article R. 5121-138-1 have been affixed to the packaging in accordance with the conditions laid down in Articles R. 5121-138-1 to R. 5121-138-4;

10° It shall report to the Agence nationale de sécurité du médicament et des produits de santé any placing on the national market of a medicinal product which it considers to be falsified within the meaning of the provisions of Article L. 5111-3, and which it manufactures, exploits and distributes.

In the event of a disagreement between a management, administrative, executive or supervisory body and the pharmacist responsible concerning the application of the rules laid down in the interests of public health, the latter shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé or, in the case of pharmacists subject to the provisions of article L. 4138-2 of the Defence Code, the technical inspector of the pharmaceutical services of the armed forces, who shall, if necessary, refer the matter to the Director General of the Agency.

The pharmacist in charge shall take part in the deliberations of the management, administrative, executive or supervisory bodies, or those of any other body with an executive function, of the company or organisation, when these deliberations concern or may affect the performance of the tasks for which he is responsible and listed from 1° to 10° of this article.