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Showing 10601–10610 of 36632 articles for “Art. al. 5”
…reactions; 4° The classification of the medicinal product in the categories mentioned in article R. 5121-36, if different from that indicated in the marketing authorisation. It specifies its period of…
…he doctors who prescribed the medicinal product, the pharmacists or persons mentioned in article L. 5126-10 who dispensed it, the regional pharmacovigilance centres and, where appropriate, the poison…
I.- The maximum value of the period referred to in the second paragraph of II of article L. 5121-12-1 is set at twelve months from the date on which the authorisation referred to in this article is gr…
…s replacement is carried out without opening the immediate packaging as defined in 3° of article R. 5121-1 and in compliance with the good practices mentioned in article L. 5121-5.Safety devices are c…
I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisa…
…uthorisation in France;-the classification of the product in the categories mentioned in article R. 5121-36.
For each parallel import operation, the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the author…
…llowing information and documents, presented in accordance with the order referred to in Article R. 5121-11 : 1° The name and address of the applicant and, where applicable, those of the company explo…
The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescri…
…oduct benefiting from the parallel import authorisation complies with the provisions of Articles R. 5121-118, R. 5121-119 and R. 5121-128.
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