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Showing 10721–10730 of 36632 articles for “Art. al. 5”
For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product fo…
For the application of 5° of article R. 5121-28, when reference is made to published literature recognised in the tradition of homeopathic medicine practised in France, experts justify, on the basis o…
…older of a marketing authorisation for a medicinal product granted under 1°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality concerned, of the fact that f…
For the application of the provisions of 1° of Article R. 5121-28, the Director General of the Agence française de sécurité sanitaire des produits de santé may exempt the applicant for a marketing aut…
…for health and social security and, for the medicinal products mentioned in 1° of II of Article L. 5121-12, to the Agence nationale de sécurité du médicament et des produits de santé, indicating the…
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
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…
…s produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited…
…withdraw an early access authorisation when one of the conditions set out in I and II of article L. 5121-12 is no longer met or for any of the reasons mentioned in 3° of VI of the same article. II.-Wh…
…of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5121-51-8 and R. 5121-51-9, the Director General of the Agence nationale de sécurité du médicament e…
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