Règlement grand-ducal du 4 mai 2010 modifiant le règlement grand-ducal modifié du 15 décembre 1992 relatif à la mise sur le marché des médicaments.

This preamble identifies the regulation as an amending decree on the marketing of medicines and lists the legal and advisory texts it relies on.

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Jurisdiction: Luxembourg
Instrument: Regulation
Citation: http://data.legilux.public.lu/eli/etat/leg/rgd/2010/05/04/n1/jo
Status: In force
Version: Undated source snapshot
Language: fr
Updated: 4 May 2010
Official source: View official record ↗

market authorization marketing authorization medicines pharmaceutical compliance regulatory execution regulatory filing

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This preamble identifies the regulation as an amending decree on the marketing of medicines and lists the legal and advisory texts it relies on. The replaced sentence says that, for this request, the required information and documents must be attached and presented according to Annex I of Directive 2001/83/CE. This article replaces references to Directive 2001/83/CE in specified provisions with a reference to “directive 2001/83/CE précitée”. Le Ministre de la Santé est chargé d’exécuter le règlement, qui sera publié au Mémorial.

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Provisions of Règlement grand-ducal du 4 mai 2010 modifiant le règlement grand-ducal modifié du 15 décembre 1992 relatif à la mise sur le marché des médicaments.

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Preamble

preamble
Preamble
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AI-assisted research summary: This preamble identifies the regulation as an amending decree on the marketing of medicines and lists the legal and advisory texts it relies on.

Le contenu de la version HTML du Journal officiel luxembourgeois est identique Ã la version PDF. RÃ¨glement grand-ducal du 4 mai 2010 modifiant le rÃ¨glement grand-ducal modifiÃ© du 15 dÃ©cembre 1992 relatif Ã la mise sur le marchÃ© des mÃ©dicaments. Nous Henri, Grand-Duc de Luxembourg, Duc de Nassau, Vu la loi modifiÃ©e du 11 avril 1983 portant rÃ©glementation de la mise sur le marchÃ© des mÃ©dicaments; Vu la directive 2009/120/CE de la Commission du 14 septembre 2009 modifiant la directive 2001/83/CE du Parlement europÃ©en et du Conseil instituant un code communautaire relatif aux mÃ©dicaments Ã usage humain en ce qui concerne les mÃ©dicaments de thÃ©rapie innovante; Vu l'avis du CollÃ¨ge mÃ©dical; Vu l'avis de la Chambre de Commerce; Vu l'article 2, paragraphe 1 er de la loi du 12 juillet 1996 portant rÃ©forme du Conseil d'Etat et considÃ©rant qu'il y a urgence; Sur le rapport de Notre Ministre de la SantÃ© et aprÃ¨s dÃ©libÃ©ration du Gouvernement en Conseil; ArrÃªtons: â

1 er
Art. 1 er .
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AI-assisted research summary: The replaced sentence says that, for this request, the required information and documents must be attached and presented according to Annex I of Directive 2001/83/CE.

Art. 1 er . La premiÃ¨re phrase de l'alinÃ©a 4 l'article 1 er du rÃ¨glement grand-ducal modifiÃ© du 15 dÃ©cembre 1992 relatif Ã la mise sur le marchÃ© des mÃ©dicaments est remplacÃ©e par les dispositions suivantes: â Â«Â Â Â Â Â A cette demande doivent Ãªtre jointes les renseignements et les documents suivants, prÃ©sentÃ©s conformÃ©ment Ã l'annexe I de la directive 2001/83/CE du Parlement EuropÃ©en et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux mÃ©dicaments Ã usage humain, telle qu'elle a Ã©tÃ© ou sera modifiÃ©e: â â â â â Â Â Â Â Â Â» â
2
Art. 2.
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AI-assisted research summary: This article replaces references to Directive 2001/83/CE in specified provisions with a reference to “directive 2001/83/CE précitée”.

Art. 2. Aux articles 1. alinÃ©a 4 point 11., 1.-1. point 4., 1.-2., 5.-1. points 6. et 8., 7., 8. et 52.-4. point 1 a) toute rÃ©fÃ©rence Ã la directive 2001/83/CE est remplacÃ©e par celle de Â«directive 2001/83/CE prÃ©citÃ©eÂ». â
3
Art. 3.
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AI-assisted research summary: Le Ministre de la Santé est chargé d’exécuter le règlement, qui sera publié au Mémorial.

Art. 3. Notre Ministre de la SantÃ© est chargÃ© de l'exÃ©cution du prÃ©sent rÃ¨glement qui sera publiÃ© au MÃ©morial. Le Ministre de la SantÃ©, Mars di Bartolomeo Palais de Luxembourg, le 4 mai 2010. Henri

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