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Product dat aescine bevat
Product dat auranofine bevat
Product dat auranofine in orale vorm bevat
Product dat bacitracine bevat
Product dat baclofen bevat
Product dat balsalazide bevat
Product dat barbituraat bevat
Product dat baricitinib bevat
Product dat basiliximab bevat
Product dat enkel auranofine in orale vorm bevat
”Your medicines and health products are our concern”

Traduction de «products concerned » (Néerlandais → Français) :

TERMINOLOGIE
voir aussi les traductions en contexte ci-dessous














product dat enkel auranofine in orale vorm bevat

produit contenant seulement de l'auranofine sous forme orale




TRADUCTIONS EN CONTEXTE
narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the remov ...[+++]

narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the remov ...[+++]


As for D-glucuronolactone, the group believes that this concerns a normal human metabolite deriving from glucose, which does not involve a structural risk with regard to mutagenicity or carcinogenicity. It also holds that both this component as well as its hydrolysis product, glucuronic acid, are endogenous metabolites in humans and other mammals, that they are naturally present in various food sources and that they are quickly metabolised into innocuous products and excreted.

Pour la D-glucuronolactone, le groupe considère qu’il s’agit d’un métabolite humain normal provenant du glucose qui ne présente pas de risque structural en termes de mutagénicité ou de carcinogénicité, que pour ce composant, comme pour son produit d’hydrolyse, l’acide glucuronique, il s’agit de métabolites endogènes chez l’homme et les autres mammifères, qu’ils se trouvent à l’état naturel dans diverses sources alimentaires et qu’ils sont rapidement métabolisés en produits sans danger et excrétés.


A few years later, the same SCF published an additional report that was triggered by the fact that the firm which produces “Red Bull” had made available further information and experimental data concerning the product.

Le même SCF a publié quelques années plus tard un rapport complémentaire suite à l’envoi par le principal fabriquant de ces boissons d’autres informations et données expérimentales sur le produit et suite à la prise en compte d’autres développements (SCF, 2003).


Nevertheless, in view of the fact that this type of drink is already allowed in several European countries and taking into account the European regulations concerning this type of product, in the end, the competent French authorities have been obliged to give their approval (Decree of the European Court of Justice, Press release No. 12/04, 2004) for this beverage, which was marketed on 15 July 2008.

Néanmoins, considérant que ce type de boisson est déjà autorisé dans plusieurs pays d’européens et compte tenu de la réglementation européenne sur ce type de produit, les autorités compétentes françaises ont finalement dû l’autoriser (Arrêt de la Cour de Justice européenne, Communiqué de presse n° 12/04, 2004). Sa commercialisation a effectivement débuté en date du 15 juillet 2008.


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”Your medicines and health products are our concern

”Your medicines and health products are our concern


At European level, important texts were adopted such as Directive 2007/47/EC amending Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, and Regulation (EC) no. 1394/2007 on advanced therapy medicinal products.

At European level, important texts were adopted such as Directive 2007/47/EC amending Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, and Regulation (EC) no. 1394/2007 on advanced therapy medicinal products.


- wederzijdse erkenningsprocedure en gedecentraliseerde procedure MRP/DCP (PPT, 248 Kb) ; Strategy paper (PDF, 13.4 Kb) for RMS request in view of the Decentralized procedure (DCP) concerning medicinal products for human use (update 04/2013) ; DCP Request Template (DOC, 121 Kb)

- procédure de reconnaissance mutuelle et procédure décentralisée MRP/DCP (PPT, 248 Kb) ; Strategy paper (PDF, 13.4 Kb) for RMS request in view of the Decentralized Procedure (DCP) concenring medicinal products for human use (update 04/2013) ; Template for DCP Request (DOC, 121 Kb)


This certificate permits the manufacturer to affix the CE conformity marking on the products concerned.

This certificate permits the manufacturer to affix the CE conformity marking on the products concerned.




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Date index: 2023-08-18
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