Article R5141-123-8
…may differ from the veterinary medicinal product which has obtained marketing authorisation in France, provided that these differences have no therapeutic impact and do not entail any risk to public…
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Showing 4771–4780 of 18855 articles for “Art. CE 8-7-2005 n° 253291”
…may differ from the veterinary medicinal product which has obtained marketing authorisation in France, provided that these differences have no therapeutic impact and do not entail any risk to public…
…rgans or tissues or vascularised tissues for which it is granted; 2° The indication or situation concerned; 3° Whether the activity concerns children, adults and children or adults only; 4° The site o…
…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…
The health care establishment authorised to carry out the activity of exceptional organ or tissue transplantation or composite vascularised tissue transplantation must be able to ensure its implementa…
…n is sent to the Director General of the Regional Health Agency, by any means which provides a date certain of its receipt, by the health establishment seeking authorisation. The composition of the ap…
Exceptional organ or tissue transplants or exceptional composite transplants of vascularised tissues may not be carried out as part of the self-employed activities of statutory full-time practitioners…
The national committee rules on authorisation to carry out exceptional transplants and issues the opinion provided for in the first paragraph of I of article L. 162-30-5 of the Social Security Code. I…
The health care organisation holding the authorisation submits its application for renewal of the authorisation fourteen months before the expiry date of the authorisation under the same conditions as…
…the Minister for Health will issue a decree laying down specific quality and safety rules for an exceptional type of transplant.
Each year, the health care organisation which holds the authorisation sends an activity and assessment report to the regional health agency, the general directorate for healthcare provision and the bi…
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