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Showing 7511–7520 of 17844 articles for “Art. 815-5”
For the purposes of calculating the number of staff referred to in articles R. 5142-38 and R. 5142-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
When a pharmacist or assistant veterinarian recruited in application of article R. 5142-37 is absent or replaces the pharmacist or veterinarian in charge for a period of more than one month, he is rep…
Assistant pharmacists or veterinary surgeons entrusted with the release of batches must have at least six months' professional experience under the conditions set out in article R. 5142-16 before taki…
For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory i…
As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up…
As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up…
When providing systemic cancer treatment by immunotherapy or innovative therapeutic medicinal products, the holder of the authorisation for systemic cancer treatment has a patient care organisation wh…
I-Treatment of cancer by systemic medicinal treatments for cancer consists, within the authorised site : 1° The development of a therapeutic proposal in a multidisciplinary consultation meeting, follo…
I. - Establishments authorised for systemic medicinal treatments for cancer with designation B or C must have on site : 1° The organisation of a medical permanence at least by means of operational on-…
The establishment authorised to provide systemic medicinal treatments for cancer with a C rating complies with the obligations imposed on holders of authorisations for medicine caring for children and…
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