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Showing 1981–1990 of 32624 articles for “Art. R. 232-17”
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
…1, the dossier also includes :1° The intended purpose of the device(s) as defined in 1° of Article R. 5211-4 ; 2° The design specifications, including the standards applied and the results of the ris…
…y requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefi…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
…ement et du travail under the conditions provided for in the fourth and fifth paragraphs of Article R. 533-29 of the Environment Code.
…activities with the aim of curing the tumour, with the exception of the provisions of 2° of article R. 6123-91-1, those of I and III of article R. 6123-91-3, as well as the provisions of articles R. 6…
…ndovenous and endoarterial routes; 4° Category D comprising all the procedures mentioned in article R. 6123-165, including therapeutic interventional radiology procedures, performed on a permanent bas…
The authorisation holder guarantees that the medical biology tests required for the activity will be carried out within a timeframe compatible with the quality of patient care.
The interventional radiology activity referred to in 21° of article R. 6122-25 includes all medical procedures for diagnostic or therapeutic purposes performed with medical imaging guidance and contro…
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