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Showing 1661–1670 of 4474 articles for “Art. n° 17-20.696”
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…
I. - The application for authorisation of an individually prepared advanced therapy medicinal product is accompanied by a dossier, the content of which is laid down by decision of the Director General…
In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or…
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…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date…
The provisions of sub-section 2 of section 7 of this chapter relating to cancer treatment activities are applicable to the holder of the authorisation under grades C and D when it carries out interven…
Authorisation for interventional radiology activities may be issued for the following categories : 1° Category A including, with the exception of procedures specifically covered by categories B, C and…
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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