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Showing 10751–10760 of 36632 articles for “Art. al. 5”
…of the early access authorisation issued for a medicinal product covered by 1° of II of Article L. 5121-12 to disseminate the authorisation, or any information relating to this authorisation, to the…
…t by 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 p…
…ic methods. These modifications must first be authorised under the conditions set out in article R. 5121-41-1.
…in support of the application for authorisation of the medicinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficient data for the evalu…
I.-For the medicinal products mentioned in Article L. 5121-12, the early access authorisation: 1° Is granted for a maximum period determined by decree, renewable by the High Authority for Health; 2° C…
I.-The application for authorisation to obtain the early access provided for in Article L. 5121-12 is sent by electronic means, by the holder of the exploitation rights or his authorised representativ…
Without prejudice to the provisions of 2° of Article R. 5121-50, each year the Agence nationale de sécurité du médicament et des produits de santé publishes on its website the list of medicinal produc…
…roprietary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may…
…he marketing authorisation lapses is counted from : 1° the date of publication of Decree No. 2008-435 of 6 May 2008 for marketing authorisations issued up to that date, with the exception of those for…
…lication file. When the Director General of the Agency makes use of the option granted to him under 5° of Article R. 5121-34, these time limits are suspended until the additional information required…
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