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Showing 631–640 of 12493 articles for “Art. 7 févr. 2019”
As part of the monitoring obligations laid down in the therapeutic use protocol and the data collection obligations for all early access authorisations, the holder of the marketing rights for the medi…
When the authorisation is suspended, withdrawn or not renewed, or when a decision to modify the authorisation makes this necessary, the holder of the early access authorisation referred to in Article…
…rst paragraph of article L. 5123-2 of the present code or in the first paragraph of article L. 162-17 of the Social Security Code in the indication in question is no longer met, the early access autho…
…ne the preventive recovery plan pursuant to Article L. 613-36 or, where applicable, Article L. 613-37 ; 2° Refer the matter to the authority responsible for supervision on a consolidated basis so that…
Authorisation for oncological surgery of the otorhinolaryngeal and maxillofacial sphere with grades A and B may only be granted if the health care establishment has an organisation allowing access, on…
The provisions of Article L. 2191-7 apply.
The provisions of article R. 2151-7 apply.
…APPLICABLE PROVISIONS IN THE VERSION RESULTING FROM R. 2122-1 to D. 2122-3 decree no. 2000-318 of 7 April 2000 D. 2122-4 decree no. 2000-1250 of 18 December 2000 D. 2122-5 to D. 2122-6 decree no. 20…
The holder of the marketing rights for the medicinal product which is the subject of the early access authorisation or, where applicable, his authorised representative, shall immediately forward to th…
The authorisation holder is recognised as a hospital cancer molecular genetics platform by the Institut National du Cancer in application of article L. 1415-2 or has a cooperative organisation with ot…
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