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Showing 5941–5950 of 24797 articles for “Art. 4 mars 2021”
The organisation of the management and the determination of the powers of the Executive Chairmen are set out in the Articles of Association in accordance with the conditions set out in article 11 of l…
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…
For any medicinal product authorised on the French market, each of its presentations and, where applicable, each common dispensing unit, is allocated a national identification number. This number is a…
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…
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