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Showing 3251–3260 of 68221 articles for “Art. I-3° and Art. 156 bis”
…on of applications made up of two members of the national disciplinary commission, one a magistrate and the other a judge of a commercial court, appointed each year by the chairman of the national dis…
…product is marketed. After the marketing authorisation has been granted, the manufacturing methods and control techniques referred to in the pharmaceutical dossier shall be amended in the light of te…
For the purposes of Article L. 5141-5, type II variations and extensions as defined in 3° and 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination…
…logically 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 procedures for the establishment of residue l…
…nation of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, is also subject to authorisation. All these authorisations are co…
The marketing authorisation holder submits to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail any proposed amendment to the label…
…for renewal is accompanied by a summary list of the documents submitted relating to quality, safety and efficacy, including all the changes authorised since the initial authorisation or the last renew…
…nt. To this end, the practitioners: 1° In facilities organised on a continuous basis, carry out day and night work under the conditions defined by the internal regulations and the duty roster; 2° In o…
Contractual practitioners are entitled to a minimum daily rest period of eleven consecutive hours per twenty-four hour period. By way of derogation from the provisions of the previous paragraph, in th…
…lf-days. The weekly service of practitioners recruited under the terms of 3° of article R. 6152-338 and working part-time may not be less than five half-days. The weekly service of contractual practit…
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