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Showing 4801–4810 of 25610 articles for “Art. Cass. com. – 7 Oct. 1997 – no. 95-14.158”
The competent authority's assessment of the applicant's command of the French language results in a decision that may be appealed to the administrative court with territorial jurisdiction.
Articles R. 5121-51 to R. 5121-51-4 are applicable to homeopathic medicinal products subject to the registration referred to in article L. 5121-13. This sub-section does not apply to homeopathic medic…
The purpose of the compassionate prescribing framework referred to in Article L. 5121-12-1 is to ensure the safety of prescribing a medicinal product which does not comply with its marketing authorisa…
…tablished following a report from one of the organisations mentioned in 1° to 4° of article R. 5121-76-2, in a given therapeutic indication. The list of medicinal products covered by a compassionate p…
…édicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence may grant the authorisation for use provided for in Article R. 5121-…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Articl…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et…
Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the…
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…
…ws 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 t…
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