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Showing 1721–1730 of 52053 articles for “Art. II-5°”
The marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that: 1° That it is not followed by the marketing of the medicinal…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the mar…
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
The marketing authorisation is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The authorisation includes the national number identifying th…
When a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No…
The marketing authorisation may impose one or more of the following conditions, which must be mentioned in the risk management system: 1° The implementation of measures to ensure the safe use of the m…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
Following the granting of a marketing authorisation, including for an authorisation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits…
Any change in the marketing authorisation holder is subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé.The application must i…
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…
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