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Showing 2201–2210 of 24963 articles for “Art. Aut. conc. n° 18-DCC-65 du 27 Apr 2018”
The competent authority's assessment of the applicant's command of the French language results in a decision that may be appealed to the administrative court with territorial jurisdiction.
The holder of a parallel import authorisation for a proprietary veterinary medicinal product shall immediately inform the marketing authorisation holder in the country of origin of any serious adverse…
The resale of a second-hand in vitro diagnostic medical device means any transfer of a medical device that is neither new nor refurbished within the meaning of 6° of Article R. 5221-4. The second-hand…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
The provisions of this section do not apply when : 1° The device is sold to a manufacturer of an in vitro diagnostic medical device, except where the latter expressly requests this from the reseller;…
…1° The results of the quality controls mentioned in articles L. 6221-9 and L. 6221-10, carried out during the previous five years, where they related to the in vitro diagnostic medical device that is…
…holder has on site : electro-physiotherapy equipment ; -a balneotherapy facility or a body weight reduction system. II - The authorisation holder provides access, on site or by agreement, to -a worksh…
…e or on call of a doctor with proven training in paediatric and congenital cardiology; 4° For the "adult ischaemic and structural heart disease" modality, the presence on site or on call of a doctor s…
…archiving and sharing images in order to improve the quality of care and the relevance of the procedures performed. The holder of the authorisation, with the exception of holders of the authorisation…
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