Règlement grand-ducal du 14 juin 2013 modifiant le règlement grand-ducal du 24 décembre 1993 fixant les droits dus pour la mise sur le marché des médicaments.

This preamble identifies a Grand-Ducal regulation amending the fee rules for placing medicines on the market.

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Jurisdiction: Luxembourg
Instrument: Regulation
Citation: http://data.legilux.public.lu/eli/etat/leg/rgd/2013/06/14/n4/jo
Status: In force
Version: Undated source snapshot
Language: fr
Updated: 14 Jun 2013
Official source: View official record ↗

government administration market-entry fees marketing authorization fee pharmaceuticals

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Statute overview

About this statute

This preamble identifies a Grand-Ducal regulation amending the fee rules for placing medicines on the market. Article 1er is replaced by a new provision, but the replacement text is not included in the source excerpt. A fee must be paid when filing a medicine marketing authorization request: €600 if the product already has an authorization in an EU member state, or €12,500 if it does not. The Minister of Health and the Minister of Finance are responsible, each for their own part, for carrying out this regulation.

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Provisions of Règlement grand-ducal du 14 juin 2013 modifiant le règlement grand-ducal du 24 décembre 1993 fixant les droits dus pour la mise sur le marché des médicaments.

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Part preamble

Preamble

preamble
Preamble
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AI-assisted research summary: This preamble identifies a Grand-Ducal regulation amending the fee rules for placing medicines on the market.

Le contenu de la version HTML du Journal officiel luxembourgeois est identique Ã la version PDF. RÃ¨glement grand-ducal du 14 juin 2013 modifiant le rÃ¨glement grand-ducal du 24 dÃ©cembre 1993 fixant les droits dus pour 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© et de la publicitÃ© des mÃ©dicaments et notamment son article 16; Vu lâavis du CollÃ¨ge mÃ©dical; Vu lâavis de la Chambre de commerce; Notre Conseil dâEtat entendu; Sur le rapport de Notre Ministre de la SantÃ© et de Notre Ministre des Finances 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: Article 1er is replaced by a new provision, but the replacement text is not included in the source excerpt.

Art. 1 er . Le rÃ¨glement grand-ducal du 24 dÃ©cembre 1993 fixant les droits dus pour la mise sur le marchÃ© des mÃ©dicaments est modifiÃ© comme suit: 1) Lâarticle 1 er est remplacÃ© par la disposition suivante: â Â«Â Â Â Â Â
1 er
Art. 1 er .
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AI-assisted research summary: A fee must be paid when filing a medicine marketing authorization request: €600 if the product already has an authorization in an EU member state, or €12,500 if it does not.

Art. 1 er . : Le droit fixe Ã verser Ã lâadministration de lâenregistrement et des domaines lors de lâintroduction auprÃ¨s du ministre de la SantÃ© dâune demande dâautorisation de mise sur le marchÃ© dâun mÃ©dicament est de six cents euros, lorsque le produit est dÃ©jÃ pourvu dâune autorisation dans un Etat membre de lâUnion europÃ©enne, conformÃ©ment aux directives en la matiÃ¨re. Le droit est de douze mille cinq cents euros, lorsque pareille autorisation fait dÃ©faut. Ce droit est dÃ» pour chaque forme pharmaceutique et chaque dosage du mÃ©dicament. â â â â â Â Â Â Â Â Â» 2) Lâarticle 3 est remplacÃ© par la disposition suivante: â Â«Â Â Â Â Â
3
Art. 3.
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Art. 3. : Le maintien de lâautorisation de mise sur le marchÃ© dâun mÃ©dicament est subordonnÃ© au versement Ã lâadministration de lâenregistrement et des domaines dâun droit annuel de cent euros. Ce droit doit Ãªtre versÃ© au plus tard au 31 janvier de chaque annÃ©e, faute de quoi le mÃ©dicament est retirÃ© dâoffice du marchÃ©. Ce droit est dÃ» pour chaque forme pharmaceutique et chaque dosage du mÃ©dicament. â â â â â Â Â Â Â Â Â» â
2
Art. 2.
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AI-assisted research summary: The Minister of Health and the Minister of Finance are responsible, each for their own part, for carrying out this regulation.

Art. 2. Notre Ministre de la SantÃ© et Notre Ministre des Finances sont chargÃ©s, chacun en ce qui le concerne, de lâexÃ©cution du prÃ©sent rÃ¨glement qui sera publiÃ© au MÃ©morial. Le Ministre de la SantÃ©, Mars Di Bartolomeo Le Ministre des Finances, Luc Frieden Palais de Luxembourg, le 14 juin 2013. Henri

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