Article L5121-9-3
In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et d…
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Showing 9371–9380 of 33460 articles for “Art. 757-3”
In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et d…
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…
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 the wholesaler-distributor has fulfilled its public service obligations as set out in article L. 5124-17-2, it may sell medicinal products outside the national territory or to wholesale distribut…
To meet specific defence requirements, the medical supply establishments of the armed forces health service may repackage and repackage health products in accordance with the rules laid down by the Ag…
The provisions of articles L. 5121-29 to L. 5121-32 and of the I of article L. 5121-33 do not apply to the Pharmacie centrale des armées, when the latter holds a marketing authorisation or exploits a…
The Director General of the Regional Health Agency defines the district of a municipality on the basis of its geographical unit and the presence of a resident population. The geographical unit is dete…
When carrying out their activity on national territory, the qualified person in pharmacovigilance referred to in paragraph 8 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall have prof…
Tattoo products must be manufactured in accordance with good manufacturing practice, the principles of which are defined by order of the ministers responsible for consumer affairs and health, issued o…
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