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Showing 9861–9870 of 30080 articles for “Art. FSB+R”
Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of advanced therapy medicinal products prepared on…
I. - Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or autho…
The pharmacist applying for registration on the Register shall provide the documents referred to in article R. 4112-1, with the exception of 3°.He shall also provide a copy, accompanied if necessary b…
With a view to their inclusion in the register of generic groups referred to in Article L. 5121-10, generic medicinal products are identified by a decision of the Agence nationale de sécurité du médic…
The application must be accompanied by : 1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sé…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
Any veterinary pharmaceutical establishment of a company mentioned in Article R. 5142-1 engaged in wholesale, free transfer or wholesale distribution shall keep, for each incoming and outgoing transac…
The call for candidates referred to in I of article R. 6111-42 includes at least the following elements: 1° The definition of the permanent care assignment; 2° The obligations linked to its exercise,…
All employees exercising hierarchical authority are responsible for ensuring compliance with the ethical rules applicable to all employees under their authority. To this end : 1° They shall explain th…
I.-Where the purpose of a cooperation grouping is to use the authorisations held by one or more of its members, the decision of the Director General of the Regional Health Agency provided for in Artic…
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