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Showing 7281–7290 of 24499 articles for “Art. 4 Dec 2013”
Employees of public health establishments, private health establishments and health centres who are members of the Haut Conseil des professions paramédicales are entitled to special leave of absence f…
Generic proprietary medicinal products whose active substance(s) is/are exclusively one or more mineral substances are covered by the provisions of articles R. 5121-5, R. 5121-5-1 and R. 5121-5-2.
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…
…onsequences of its use. III. -The examination of the application and the conditions under which the decision to grant early access authorisation is taken, as defined in III and IV of article R. 5121-6…
…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…
…neral of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and time limits, vary the marketing authorisation where i…
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…
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