Article R5141-123-18
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…
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Showing 1301–1310 of 29136 articles for “Art. 18 mai 2022”
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;…
…internal quality controls carried out during the previous five years; 4° Documents relating to the maintenance of the in vitro diagnostic medical device since it was put into service; 5° A descriptio…
I.-The authorisation 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 ag…
The holder of the authorisation guarantees, 24 hours a day, every day of the year: 1° For Rhythmology modality A, the presence on site or on call of a doctor specialising in cardiovascular medicine; 2…
The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19 and in Article R. 1333-70.
The provisions of articles R. 6153-24 to R. 6153-24-4 are applicable to junior doctors.
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