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Showing 5121–5130 of 14711 articles for “Art. 6 oct. 2016”
…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…
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.
The members of the Regional Employment, Training and Vocational Guidance Committee are appointed for a term of three years.Any vacancy or loss of the capacity in respect of which they have been appoin…
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