Article R5141-123-11
…tial risk to human or animal health within sixty days from the date of receipt of the complete application referred to in Article R. 5141-123-9 . The period mentioned in the previous paragraph is redu…
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Showing 4471–4480 of 32005 articles for “Art. Cass. com. 15 October 1996 n° 94-18.903 · CA Paris 7 November 2014 n° 12/17749”
…tial risk to human or animal health within sixty days from the date of receipt of the complete application referred to in Article R. 5141-123-9 . The period mentioned in the previous paragraph is redu…
…antitative and qualitative composition in active ingredients and excipients and the same pharmaceutical form as those of a veterinary pharmaceutical product that has obtained a marketing authorisation…
…the parallel import authorisation is responsible for placing the product on the market and, in this capacity, ensures that the provisions of this Title are complied with, in particular those relating…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail notifies the holder of the parallel import authorisation for a proprietary v…
…company mentioned in article R. 5142-1 plans to close one of its establishments authorised in application of the provisions of article R. 5142-5, it informs the Agence nationale de sécurité sanitaire…
…ect to the specific provisions relating to them respectively, which are set out in articles R. 5132-78, R. 5132-27 and R. 5132-91.
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…
…tence by means of an agreement: 1° Advice and expertise for other holders of authorisations for medical and rehabilitation care; 2° The care of patients from other establishments authorised to provide…
The authorisation holder must ensure continuity of care. Through the organisation it puts in place, it guarantees the intervention of a doctor within a timeframe compatible with patient safety. This o…
The authorisation holder may provide specific care requiring particular expertise, the list of which is drawn up by the Minister for Health. These are included in the multiannual contract of objective…
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