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Showing 2191–2200 of 56508 articles for “Art. Cass. com. 13-1-2009 n° 07-20.097”
For the purposes of this chapter, the following definitions shall apply 1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150…
Pharmacovigilance includes: 1° The reporting of adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse a…
This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Ar…
…ED FOR IN Article L. 411-1 Order no. 2020-116 of 12 February 2020 Articles L. 411-2 and L. 411-3Loi n° 92-597 du 1er juillet 1992 Articles L. 411-4 and L. 411-5 Order no. 2020-116 of 12 February 2020…
In authorised establishments and in liaison with their directors, the medical managers of transplant activities and those of intensive care and continuous monitoring units draw up agreements defining…
The health care establishment organises a medical service specifically for transplants, provided by a surgeon and a doctor with one of the qualifications mentioned in 3° of article D. 6124-163. It has…
The health establishment authorised to carry out organ transplant activities has the following facilities on site : - the means to ensure extracorporeal blood circulation, long-term mechanical circula…
The number of medical and paramedical staff is adapted to the organ transplant activity and the follow-up of transplant patients. It includes : 1° At least two surgeons who have each completed four ye…
The pharmacovigilance correspondent for blood-derived medicinal products mentioned in article R. 5121-181 is responsible within the establishment for dispensing and monitoring these medicinal products…
In health establishments and health cooperation groups with an in-house pharmacy, the pharmacist managing this pharmacy is the correspondent of the regional pharmacovigilance centre for blood-derived…
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