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Showing 2951–2960 of 46455 articles for “Art. I bis”
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…
The procedures for applying this chapter are determined by decree in the Conseil d'Etat, and in particular :1° The scientific criteria justifying, where appropriate, exemption from bioavailability stu…
Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.
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…
For a generic or hybrid medicinal product defined in 5° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the reference…
Persons liable for the contribution provided for in I of Article L. 245-6 of the Social Security Code and persons liable for value added tax pursuant to Article 256 A of the General Tax Code who make…
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…
Homeopathic medicinal products which satisfy all the conditions listed below are not subject to the marketing authorisation provided for in Article L. 5121-8: 1° Oral or external administration ; 2° N…
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…
Non-clinical trials intended to assess the properties and safety of medicinal products for human use must comply with good laboratory practice, the principles of which are laid down by decision of the…
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