Article R5121-45
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
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Showing 3361–3370 of 21547 articles for “Art. Cass. com. 25 March 2014”
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
…pplicable, in accordance with the conditions set out in the general regulations of the Autorité des marchés financiers. The provisions of the Civil Code relating to joint ownership and those of articl…
A reviewable price is a price which may be modified, under the conditions set out in this article, to take account of economic variations.When the price is reviewable, the contract terms set out the d…
The purpose of specific pre-project studies is :1° To assess the consequences of the technical solution studied by the economic operator responsible for the works or the supplier of industrial product…
Where the tenderer presents subcontractors when submitting the tender, it shall provide the purchaser with a declaration stating: 1° The nature and amount of the services that are the subject of the s…
The company or organisation exploiting a medicinal product or health product shall immediately notify the National Agency for the Safety of Medicines and Health Products of any prohibition or restrict…
Any advertising to the public of a medicinal product within the meaning of Article L. 5122-1 is punishable by one year's imprisonment and a fine of €150,000:1° Subject to medical prescription ;2° Reim…
The reference list of similar biological groups provided for in article L. 5121-10-2 is presented for each reference biological medicinal product for which the name, strength, pharmaceutical form and…
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…
The Director General of the Agency may automatically vary, suspend or cancel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in A…
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