Article R5121-215
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…
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Showing 8891–8900 of 30978 articles for “Art. Cass. 1ère civ. 7-11-2018 n° 17-26.222 F-PB”
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…
…lting from the decree no. 2022-894 of 15 June 2022 D. 314-24 to D. 314-26 Resulting from the décret n° 2016-884 du 29 juin 2016 D. 314-27 Resulting from the décret n° 2018-431 du 1er juin 2018 D. 314-…
For the application of 14° of I of Article L. 561-36, the competent administrative authority for monitoring compliance by the persons mentioned in 8°, 11° and 15° of Article L. 561-2 with the obligati…
Inspections to ensure that the persons referred to in 10°, 11° bis and 14° of Article L. 561-2 are complying with the obligations referred to in the first paragraph of I of Article L. 561-36 are condu…
For the application of 14° of I of Article L. 561-36, the administrative authority responsible for monitoring compliance by the persons mentioned in 9° of Article L. 561-2 with the obligations mention…
The documents, information and evidence required by the officers to carry out their inspection duties will be made available to them on request.
The report referred to in V of Article L. 561-36 shall contain the following information: 1° The sanctions that the supervisory authorities referred to in this V impose on the persons referred to in A…
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…
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