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Showing 2921–2930 of 53011 articles for “Art. CE 1-10-2013 n° 361440”
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the…
…d, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
Tattoo products are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all thes…
In specific cases of Community interest, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant shall refer the matter…
…mmunicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforehand or simultaneously in the event of an emergency, to the Direct…
Authorisation may only be granted if the holder has access, on site or by agreement, to medical biology tests and labile blood products within a timeframe that is compatible with the safety of treatme…
Authorisation may only be granted if the holder can provide cerebral and vascular exploration by scanner and MRI, on site, twenty-four hours a day, seven days a week.The holder of the medical imaging…
I.- Where the person concerned establishes in a particular case that he is not at fault or negligent, the period of suspension provided for in articles L. 232-23-3-3 to L. 232-23-3-9 shall not apply.…
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