Article R5121-37
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
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Showing 6951–6960 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
…d in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the reasons on which the…
As long as the information concerning each medicinal product reproduces in full the summary of product characteristics mentioned in article R. 5141-15, publications intended to reference veterinary me…
…ny time and for a period of two years following the declaration provided for in Article R. 5221-35, ask the manufacturer or his authorised representative to provide a report on the experience acquired…
The purpose of vigilance of in vitro diagnostic medical devices, known as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on al…
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…formation received or requested by the Authority for the purposes of exercising supervision is such as to establish that that person is likely to fail within a period of twelve months to comply with t…
…cree no. 2016-884 of 29 June 2016 R. 712-12 Resulting from Decree no. 2017-896 of 9 May 2017 R. 712-13 to R. 712-19 Resulting from Decree no. 2016-884 of 29 June 2016 R. 713-2 Resulting from Decree no…
…daptation provisions provided for in II and III: Applicable articlesIn the wording resulting fromL. 133-1 to L. 133-2Act no. 2018-700 of 3 August 2018 L. 133-3 and L. 133-4Order no. 2017-1252 of 9 Aug…
…aim on the legal entity or securitisation fund which issues them. By way of derogation from article 1349 of the French Civil Code and article L. 228-74 of the French Commercial Code, debt securities m…
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