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Showing 8021–8030 of 69703 articles for “Art. I and II”
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…
When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scien…
When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation…
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…
For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product fo…
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…
I. - The companies referred to in III and taxed on the basis of their actual profits or exempt pursuant to Articles 44 sexies, 44 sexies A, 44 octies A, 44 duodecies, 44 terdecies to 44 septdecies may…
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