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Showing 2421–2430 of 57736 articles for “Art. s. 1133 and 13”
…the Agreement on the European Economic Area or a third country of which it is aware, without delay and no later than fifteen days following receipt of the information; b) Any suspected non-serious ad…
…s disposal on a permanent basis the services of a person responsible for pharmacovigilance residing and practising in a Member State of the European Union or a State party to the Agreement on the Euro…
…uits de santé: 1° Any serious adverse reaction suspected to be due to the allergens he has prepared and supplied, of which he is aware, without delay and no later than fifteen days following receipt o…
…ovigilance to the general public about this medicinal product or product without sending it, beforehand or, in an emergency, simultaneously, to the Director General of the Agence nationale de sécurité…
…dicinal product or product, in accordance with the procedure laid down in 1° of Articles R. 5121-26 and R. 5121-28 and in Article R. 5121-97 is required to submit a periodic safety update report: 1° U…
…y update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament and of the Council, that the marketing authorisation should be varied, the marketing authorisation h…
…nes Agency a periodic safety update report containing : 1° All information relating to the benefits and risks associated with this medicinal product or product, including the results of studies which…
…s for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or to the coordination group referred to in Article 27 of Directive 2001/83/EC of…
…lishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparation activities, are subject to the provisions of articles R. 5121-162, R. 5121…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
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