Article R5121-5-4
Generic proprietary medicinal products whose active substance(s) is/are exclusively one or more mineral substances are covered by the provisions of articles R. 5121-5, R. 5121-5-1 and R. 5121-5-2.
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Showing 7471–7480 of 32667 articles for “Art. Cass. 3e Civ. 13-5-1998 n° 70”
Generic proprietary medicinal products whose active substance(s) is/are exclusively one or more mineral substances are covered by the provisions of articles R. 5121-5, R. 5121-5-1 and R. 5121-5-2.
Unless there is a risk to patients' health, proprietary medicinal products which fulfil the conditions for being a reference proprietary medicinal product in an existing generic group may, by decision…
For the application of 2° of I of Article L. 561-5, and by way of derogation from Article R. 561-5-2, when the measures provided for in 1° to 3° of Article R. 561-5-1 cannot be implemented: 1° The per…
The members of the Board of Directors of the guarantee fund, as well as any person who, by virtue of their duties, has access to documents and information held by the guarantee fund, are bound by prof…
Without prejudice to the information required by other legislative or regulatory provisions, the container and packaging of each unit of tattooing product placed on the market free of charge or agains…
The purpose of the aptitude test to which the Prefect may decide to subject the applicant in whole or in part, under the conditions laid down in article R. 212-90-1 and in 3° of article R. 212-93, is…
Where available, the certified information referred to in article L. 4371-5-1 is used in lieu of supporting documents to fulfil the obligations set out in article L. 4371-5.
I.-The Committee meets when convened by its Chairman or at the request of the majority of its full members. The Chairman sets the agenda, based on the annual work programme adopted by the Committee an…
When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scien…
When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation…
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