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Article R5124-28-1 of the French Public Health Code

In pharmaceutical establishments created within public establishments and non-profit organisations in application of article L. 5124-9-1, the legal representative of the legal entity concerned appoints, at the same time as the pharmacist in charge, one or more interim pharmacists in charge. When an establishment or organisation manufactures advanced therapy medicinal products in several establishments, the legal representative of the legal entity concerned appoints a delegate pharmacist and one or more…

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Article R5124-29 of the French Public Health Code

In the event of the death of the pharmacist who owns a company mentioned in article R. 5124-2, the manager after his death is the pharmacist who continues to run the company under the conditions set out in article L. 5124-4. He or she is chosen from among the pharmacists mentioned in article R. 5124-27 and, as soon as he or she has accepted the duties entrusted to him or…

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Article R5124-30 of the French Public Health Code

In application of article L. 5124-4, a pharmacist delegate is replaced under the following conditions: 1° By the interim pharmacist delegate designated by the competent authority mentioned in articles R. 5124-23 to R. 5124-28-1 ; 2° Or, failing that, by an assistant pharmacist from the same company or organisation or by a pharmacist who has no other professional activity for the duration of the replacement ; 3° Or, failing this,…

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Article R5124-31 of the French Public Health Code

Pharmacists replacing or managing a pharmacy after death must provide proof of the practical experience provided for, as appropriate, in articles R. 5124-16 to R. 5124-18. Pharmacists providing a replacement for a managing or delegated pharmacist must devote themselves exclusively to this activity during the period for which they are responsible.

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Article R5124-32 of the French Public Health Code

The duties of pharmacist in charge or delegate of a company, establishment or organisation mentioned in article R. 5124-2 are incompatible with the running of a pharmacy or the management of a mutualist pharmacy or a pharmacy of a mining relief society.

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Article R5124-33 of the French Public Health Code

By way of derogation from article R. 5124-32, pharmacists and companies who own a pharmaceutical manufacturing establishment attached to their pharmacy by virtue of an authorisation to open obtained before the date of 13 February 1998 may continue to operate the said establishment at the same time as their pharmacy as long as they continue to own the latter. The pharmacists and companies mentioned in the previous paragraph are subject…

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Article R5124-34 of the French Public Health Code

The responsible pharmacist is : 1° In the companies referred to in article L. 5124-2 : a) In public limited companies other than those governed by articles L. 225-57 et seq. of the Commercial Code, the Chairman of the Board of Directors who is the Chief Executive Officer, the Chief Executive Officer or a Deputy Chief Executive Officer; b) In sociétés anonymes governed by these articles, either the Chairman of…

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Article R5124-35 of the French Public Health Code

Within one month of its implementation, the company or organisation informs the Director General of the Agence nationale de sécurité du médicament et des produits de santé, via a dedicated internet portal, of the appointment of a new responsible pharmacist as defined in Article L. 5124-2. The company or organisation shall send the competent central council of the national order of pharmacists, unless the person concerned is a pharmacist covered…

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Article R5124-36 of the French Public Health Code

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,…

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Article R5124-37 of the French Public Health Code

If the duties of a pharmacist in charge are terminated or not renewed, the person concerned may refer the matter to the central council of the relevant section of the Ordre national des pharmaciens. After hearing both parties, the Council will issue an opinion as to whether or not the person concerned has failed to fulfil the obligations incumbent upon him, in the interests of public health, in his capacity…

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