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Showing 7251–7260 of 24797 articles for “Art. 4 mars 2021”
Decisions to include a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationa…
I.-The early access authorisation may be renewed. Renewal is the subject of an application by the holder of this authorisation addressed to the Haute Autorité de santé, the ministers responsible for h…
…121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing auth…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
I. - On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R.…
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…
The safety features may only be replaced by equivalent safety features in order to verify the authenticity, identify and provide proof of unlawful handling of the medicinal product. This replacement i…
…es and cells mentioned in Article R. 1211-19 and in the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq, a…
When the companies and organisations mentioned in article R. 5124-2 become aware of the falsification or suspected falsification of medicinal products which they manufacture, operate or distribute, wh…
…r, in particular via the emergency call centres or any equivalent system mentioned in article R. 5124-49-1, of supply shortages of the medicinal products which he supplies and of which he has not alre…
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