Article R5121-41-5-1
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…
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Showing 6361–6370 of 56936 articles for “Art. I-3°”
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…
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…
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 Commission referred to in the eighth paragraph of Article L. 141-2 examines applications for registration from the persons referred to in Articles L. 211-1 to L. 211-6 and, after checking that the…
The provisions of the previous article apply to commissaries attached to industrial establishments belonging to companies whose capital is owned in the majority by active or retired employees and whos…
I. - For the assessment of the 50% quota set out in I of article L. 214-28 : 1° The numerator is made up of the subscription or acquisition price of the securities or rights in the portfolio and the b…
The fact that a professional, on the pretext of presenting candidates for marriage or a stable union, brings together or causes to communicate persons, one of whom is remunerated by him, or is placed,…
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