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Showing 5941–5950 of 24354 articles for “Art. 4 avr. 2001”
I.-Articles R. 4234-7 to R. 4234-17 are applicable in New Caledonia and French Polynesia in the version resulting from Decree no. 2022-381 of 16 March 2022, subject to the adaptations provided for in…
The French pharmacopoeia is supplemented by a national formulary. The provisions of this national formulary may be made compulsory under the conditions set out in article R. 5112-2.
I.-In New Caledonia and French Polynesia, each disciplinary chamber referred to in articles L. 4441-2, L. 4441-13 and L. 4441-16 comprises, in addition to its president, four full members and four alt…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
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…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
…tary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
The committee responsible for proposing the list of approved products for public authorities, in accordance with the provisions of articles L. 5123-2 and L. 5123-3, is the Transparency Committee, the…
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