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Showing 13811–13820 of 39711 articles for “Art. al. 3”
The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this au…
…inal product. This replacement is carried out without opening the immediate packaging as defined in 3° of article R. 5121-1 and in compliance with the good practices mentioned in article L. 5121-5.Saf…
I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisa…
…or, depending on the form of administration, for a given volume or weight, using the common names; 3° The pharmaceutical form and content by weight, volume or units of administration; 4° The list of…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
…France or outside national territory and the location of such research when carried out in France; 3° An estimate of the number of patients potentially concerned in France; 4° Where the medicinal pro…
…e name or chemical symbol of the radionuclide ; 2° Identification of the batch and the expiry date; 3° The name and address of the manufacturer; 4° The international radioactivity symbol; 5° The total…
…a unique identifier and a tamper-evident device, under the conditions set out in articles R. 5121-138-1 and R. 5121-138-3. II.-The unique identifier allows persons whose activity is the wholesale dis…
…s of the European Medicines Agency for an opinion, as referred to in Article 16h of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating…
When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are…
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