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Showing 10821–10830 of 36632 articles for “Art. al. 5”
…in a hybrid group, in accordance with the Order mentioned in the last paragraph of II of Article L. 5125-23 of the Public Health Code.
Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.
With a view to their inclusion in the register of generic groups referred to in Article L. 5121-10, generic medicinal products are identified by a decision of the Agence nationale de sécurité du médic…
…s and places where the trial was conducted; 3° The information mentioned in 2° and 3° of article R. 5121-14.
…nts et des produits de santé: 1° Suspends or withdraws the decision referred to in 1° of Article R. 5121-9-2 identifying a similar biological medicinal product in the event of non-renewal, suspension,…
When a marketing authorisation is granted for a biological medicinal product which may be identified as a similar biological medicinal product, the Director General of the Agence nationale de sécurité…
…isions of this national formulary may be made compulsory under the conditions set out in article R. 5112-2.
Where an application for marketing authorisation in France is made for a medicinal product which has already been authorised or is the subject of an application for marketing authorisation currently b…
Testing of medicinal products, within the meaning of 9° of article L. 5121-20, means all chemical, pharmaceutical and biological tests, non-clinical tests and clinical trials. Without prejudice to the…
Decisions to include a medicinal product in the register of hybrid groups, to amend these decisions and to remove a medicinal product from this register, governed by this section, are published on the…
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