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Traduction de «competent authorities » (Néerlandais → Français) :

26 e meeting van de Competent Authorities for Medical Devices

26 e rencontre des Competent Authorities for Medical Devices


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.


The European directives regarding medical devices are referred to as the New Approach Directives. Products may be commercialised without the intervention of a competent authority.

The European directives regarding medical devices are referred to as the New Approach Directives. Products may be commercialised without the intervention of a competent authority.


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.


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.


Moreover, as the competent authority, the FAMHP intends to play a catalysing role in the stimulation and conduct of high-quality clinical research (e.g. general clinical research, academic clinical research, paediatric clinical research) in Belgium on an ongoing basis.

Moreover, as the competent authority, the FAMHP intends to play a catalysing role in the stimulation and conduct of high-quality clinical research (e.g. general clinical research, academic clinical research, paediatric clinical research) in Belgium on an ongoing basis.


Bron: Heads of the European Radiation protection Competent Authorities (HERCA) - 2010

Source : Heads of the European Radiation protection Competent Authorities (HERCA) - 2010


a) heeft elke gemachtigd gebruiker die, afhankelijk van zijn hoedanigheid, ofwel over een gebruikersnaam en een paswoord ofwel over een gebruikersnaam, een paswoord en een burgertoken beschikt toegang tot de toepassingen “Interface for communication on experiments between sponsors, ethics committees and the competent authority (ICE- SEC)”, “Medega”, “CEBAM Digital library for Health”, “eTCT - Feedback aan de ziekenhuizen over de door hen verstrekte zorg en de kost ervan” en “BINC (Begeleiding in Cijfers) - Online registratiesysteem voor de private voorzieningen uit de sector Bijzondere Jeugdzorg”;

a) chaque utilisateur habilité qui dispose, selon sa qualité, soit d’un Identifiant ou d’un Mot de Passe, soit d’un Identifiant, d’un Mot de Passe et d’un Token de citoyen, a accès aux applications « Interface for communication on experiments between sponsors, ethics committees and the competent authority (ICE-SEC) », « Medega », « CEBAM Digital library for Health », « eTCT - Feed-back aux hôpitaux sur leurs prestations de soins et sur leur coût » et « BINC (Begeleiding in Cijfers) - Système d'enregistrement en ligne dédié aux établissements privés du secteur de l'aide spéciale à la jeunesse » ;


Medical devices The European medical devices directives are socalled New Approach Directives: the products can be commercialised without the involvement of the competent authorities.

Medical devices The European medical devices directives are socalled New Approach Directives: the products can be commercialised without the involvement of the competent authorities.


The Council urges the authorities competent for public health to make available both this information and these warnings to the target audience of energy drinks. Finally, it requests the legislator to take the necessary measures concerning the labelling of these drinks, especially as far as the recommendations mentioned in this report are concerned.

Enfin, il encourage les autorités de Santé à diffuser, auprès du public cible des boissons énergisantes, les informations reprises ci-avant ainsi que les mises en garde énoncées et sollicite le législateur pour qu’il prenne des dispositions utiles concernant l’étiquetage de ces boissons, notamment quant aux recommandations évoquées dans ce rapport.




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Date index: 2023-05-14
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