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Showing 11601–11610 of 38939 articles for “Art. al. 4”
The marketing authorisation issued by the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail becomes null and void if it appears : 1° That it is not followed by…
…a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5141-5, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234…
…tive and quantitative composition in active substances; d) Its batch number(s); e) Its expiry date; 4° For the placebo: a) Its pharmaceutical form ; b) Its composition ; c) Its batch number(s) ; d) It…
…ntrol file for each pharmaceutical form and a description of the dilution and dynamisation methods; 4° The reference of the authorisation to manufacture the medicinal products in question or a documen…
…omeopathic veterinary medicinal product or a series of medicinal products mentioned in article L. 5141-9 is sent to the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et…
The marketing authorisation holder responsible for the study referred to in Article R. 5141-30 shall make the study protocol and report available to the Director General of the Agence nationale de séc…
…de l'environnement et du travail or by another State : 1° In the case provided for in Article R. 5141-47-2, the Director General of the Agency notifies the States concerned and the holder of the agre…
…maximum residue limit of a pharmacologically active substance in application of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedure…
The specific obligations that may be imposed in application of 1° of Article L. 5141-5-1 are as follows: 1° The applicant must complete a trial programme within a period set by the Agence nationale de…
…du travail. It is accompanied by the summary of product characteristics referred to in Article R. 5141-15 as approved by the Director General of the Agence nationale de sécurité sanitaire de l'aliment…
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