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Showing 4471–4480 of 60182 articles for “Art. I · Art. L 227-9”
The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference medicinal product within the meaning of Article L. 5121-1 may not pro…
I. - Without prejudice to decisions to vary, suspend or withdraw marketing authorisations, the Agence nationale de sécurité du médicament et des produits de santé may, in the interests of public healt…
A generic medicinal product may not be marketed until ten years have elapsed following the initial marketing authorisation of the reference medicinal product. However, this period is extended to eleve…
Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.
Any holder of a marketing authorisation for a medicinal product or any operator of such a medicinal product is required, within one year of the promulgation of Act 2011-2012 of 29 December 2011 on rei…
The company which exploits a proprietary medicinal product contributes to its proper use by ensuring in particular that the product is prescribed in compliance with its marketing authorisation referre…
When it is drawn up at the request of a patient with a view to use in another Member State of the European Union, the prescription of one of the medicinal products mentioned in 6°, 14° and 15° of Arti…
I. - Articles L. 5121-8 and L. 5121-9-1 do not preclude the exceptional use of certain medicinal products for specific therapeutic indications under compassionate access when the following conditions…
I.-To meet specific defence needs, the Minister for Defence may authorise the armed forces health service to use a proprietary medicinal product outside the conditions of prescription and supply laid…
Traditional herbal medicinal products that meet the following criteria are not subject to marketing authorisation: 1° They are designed to be used without the intervention of a doctor for the purposes…
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