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Showing 5081–5090 of 14914 articles for “Art. 6 mars 1996”
…the Haute Autorité de santé during the assessment of the application referred to in Article R. 5121-68, where applicable on a proposal from the Agence nationale de sécurité du médicament et des produi…
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
…s up a draft summary of each report, with a view to publication as provided for in Article R. 5121-76-10, and sends it to the Agency with the report. III. - Prescribers and pharmacists are required to…
…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 con…
…R. 5121-138-2, in accordance with the procedures set out in Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Cou…
For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or t…
In the event of the formation of sociétés de participations financières de profession libérale de pharmaciens d'officine by merger or takeover, articles R. 5125-24-1 to R. 5125-24-5 are applicable.
Humanitarian wholesale distributors as defined in 8° of article R. 5124-2 are subject to compliance with good practice in the donation of medicinal products, set by order of the Minister for Health an…
…in accordance with the care pathway coordinated by the attending doctor referred to inarticle L. 162-5-3 of the Social Security Code.
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