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Vertaling van "been made for various competent authorities " (Nederlands → Frans) :

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.

The Clinical Trial Facilitation Group (CTFG) is a collaborative effort to facilitate and harmonise clinical trials in Europe. Within the CTFG agreements have been made for various competent authorities to voluntarily arrive at a common evaluation for applications for clinical trials whenever this involves multicentre trials with participating centres from different Member States.


Average Wholesale Price litigation Claims have been brought against various pharmaceutical companies, including NPC and certain Sandoz entities, alleging that they fraudulently overstated the Average Wholesale Price and “best price”, which are, or have been, used by the US federal and state governments in the calculation of, respectively, Medicare reimbursements and Medicaid rebates. In some cases, motions to dismiss or (cross-) motions for summary judgment have been made and are c ...[+++]

Litige concernant le prix de gros moyen Des plaintes ont été déposées contre différentes sociétés pharmaceutiques, dont NPC et certaines entités de Sandoz, au motif que celles-ci auraient frauduleusement exagéré le prix de gros moyen (average wholesale price [AWP]) et le «meilleur prix» qui sont ou ont été utilisés par le gouvernement fédéral américain et des gouvernements d’Etat pour calculer les remboursements des médicaments dans le cadre du programme Medica ...[+++]


Average Wholesale Price litigation Claims have been brought against various pharmaceutical companies, including NPC and certain Sandoz entities, alleging that they fraudulently overstated the Average Wholesale Price and “best price”, which are, or have been, used by the US federal and state governments in the calculation of, respectively, Medicare reimbursements and Medicaid rebates. In some cases, motions to dismiss or (cross-) motions for summary judgment in other cases have been made ...[+++]

Litige concernant le prix de gros moyen Des plaintes ont été déposées contre différentes sociétés pharmaceutiques, dont NPC et certaines entités de Sandoz, au motif que celles-ci auraient frauduleusement exagéré le prix de gros moyen (average wholesale price [AWP]) et le «meilleur prix» qui sont ou ont été utilisés par le gouvernement fédéral américain et des gouvernements d’Etat pour calculer les remboursements des médicaments dans le cadre du programme Medica ...[+++]


The data in this source need, of course, to agree with those that have been approved or determined by the competent authority for marketing authorisation – MA (FAMHP), price (FPS Economy) and reimbursement modalities (RIZIV-INAMI), respectively.

The data in this source need, of course, to agree with those that have been approved or determined by the competent authority for marketing authorisation – MA (FAMHP), price (FPS Economy) and reimbursement modalities (RIZIV-INAMI), respectively.


Recognition by the relevant parties at national level and by the other competent authorities at European level for early phase development has without a doubt been a significant achievement for the R&D department and the FAMHP.

Recognition by the relevant parties at national level and by the other competent authorities at European level for early phase development has without a doubt been a significant achievement for the R&D department and the FAMHP.


This means there is a given amount of competition between the competent medicines authorities in the various European Member States for evaluating files such as these.

This means there is a given amount of competition between the competent medicines authorities in the various European Member States for evaluating files such as these.


The formation of the FAMHP is an important step towards an efficient, modern government service with sufficient management autonomy to respond flexibly to the expectations of the various stakeholders: the users of medicines, healthcare professionals, the pharmaceutical industry and the political authorities at the different levels of competency (European, federal, ...[+++]

The formation of the FAMHP is an important step towards an efficient, modern government service with sufficient management autonomy to respond flexibly to the expectations of the various stakeholders: the users of medicines, healthcare professionals, the pharmaceutical industry and the political authorities at the different levels of competency (European, federal, ...[+++]


This advisory report is largely based on expert reports and advisory reports made by the authorities competent for public health, which are themselves based on scientific articles from the international literature and reports of experimental studies.

Le présent avis est basé en grande partie sur des rapports d’expertise et des avis d’autorités de Santé publique, eux-mêmes basés sur la consultation d’articles scientifiques tirés de la littérature internationale et de rapports d’études expérimentales.


Accordingly, what follows is not meant as an exhaustive inventory of all the initiatives that have already been taken at all the levels of authority, but as a grouping together of various examples of initiatives taken in this field, based on the most important courses of action.

La présentation qui suit ne vise donc pas à dresser un inventaire exhaustif de toutes les initiatives déjà prises à tous les niveaux de pouvoir mais bien de regrouper à partir des axes d’actions principaux divers exemples d’initiatives prises dans le domaine.


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 jui ...[+++]




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Date index: 2024-10-20
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