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Showing 3411–3420 of 34828 articles for “Art. CE 25-3-2019 n° 422943”
…it has or becomes aware of which could lead to a change in the assessment of the risk-benefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It sh…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
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…
…lementation of measures to ensure the safe use of the medicinal product or product; 2° The performance of post-authorisation safety studies; 3° Compliance with specific obligations regarding the recor…
…sation, including for an authorisation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision notified i…
…permanent medical care, by direct admission to an acute geriatric medical facility; 2° In the absence of such a facility, and subject to medical availability, in any specialty facility corresponding…
Authorisation for cancer treatment by complex oncology surgery with grade B as referred to in II of Article R. 6123-87-1 may only be granted if the applicant has an organisation enabling it to: 1° Org…
…health corresponds to this type of care. The nature, complexity and medical supervision of the services provided are equivalent to those usually provided in the context of full-time hospitalisation. T…
The consultation provided for in Article L. 6143-7 takes place on the initiative and in accordance with the procedures defined by the Chairman of the Executive Board. In addition, the latter shall con…
…ts is subject to the provisions of Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108…
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