Article R5141-123-16
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…
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Showing 2281–2290 of 45413 articles for “Art. 12 al. 2”
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…
After it has been issued, the parallel import authorisation is suspended or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du…
I.- In the event of repackaging, the holder of a parallel import authorisation for a proprietary veterinary medicinal product shall notify the holder of the marketing authorisation for the proprietary…
…er in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.
For its application to La Réunion and Mayotte, in article R. 6123-27, after the words "infra-regional", the words "Mahorais, common to La Réunion and Mayotte" are added.
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 authorised site provides access to a neurocognitive platform, either on site or by agreement.
…at their request, after obtaining the opinion of the medical committee referred to in article R. 6152-36, when the person concerned is unable, on expiry of his sick leave entitlement, to resume his ac…
The educational actions undertaken as part of the education programme mentioned in 12° of I of article L. 232-5 are provided by educators approved by the agency, under the conditions it determines.
In the cases provided for by 6° of Article 706-53-2, the person must be informed and provided with the document provided for by Article R. 53-8-9 are made, under the conditions set out in the third an…
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