Article R5121-107-7
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
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Showing 5861–5870 of 57142 articles for “Art. Loi 2019-744 of 19-7-2019”
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1°…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
…ntenance. France Compétences is responsible for steering this information system and sets the terms of its governance and financial organisation. It defines and implements the common strategic framewo…
…are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all these products once…
On completion of the procedures provided for in this subsection, the marketing authorisation shall be granted or varied by the Director General of the Agence nationale de sécurité sanitaire de l'alime…
…re met:1° The veterinary medicinal product is obtained from a company authorised within the meaning of Articles 44 or 65 of Directive 2001/82/EC of the European Parliament and of the Council of 6 Nove…
When it does not take place in a paediatric emergency unit referred to in 3° of article R. 6123-1, the care of children in an emergency unit is organised in collaboration with a paediatric unit, wheth…
The holder organises a specific multi-annual training plan for each of the cancer treatment modalities for which it is authorised and intended for all healthcare professionals contributing to oncology…
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