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Showing 11871–11880 of 38939 articles for “Art. al. 4”
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
The classification of a medicinal product in the category of medicinal products requiring special monitoring during treatment has the effect of making its prescription subject to periodic examinations…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
I.- The maximum value of the period referred to in the second paragraph of II of article L. 5121-12-1 is set at twelve months from the date on which the authorisation referred to in this article is gr…
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…
…ame, or the botanical name according to the two-word system mentioned in 10° of Article R. 5121-1 ; 4° Dosage, pharmaceutical form, method and route of administration and presumed period of stability;…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General…
…tocol; 3° Where applicable, summaries of the periodic summary reports mentioned in article R. 5121-74-6. II.-The Ministers for Health and Social Security publish, on their websites, the list of medici…
The import authorisation or, for private individuals, a copy of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate…
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