Traduction de «traditional use » (Néerlandais → Français) :

Voor traditional use moet het middel gedurende minstens 30 jaar (waarvan minstens 15 jaar in minstens één land van de Europese Unie) beschikbaar zijn voor medisch gebruik (niet noodzakelijk als geregistreerd geneesmiddel).
Pour le traditional use , le produit doit être disponible (pas nécessairement comme médicament enregistré) pour un usage médical depuis au moins 30 ans (dont au moins 15 ans dans au moins un pays de l' Union européenne).

Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Advisory commission which is consulted e.g. in cases of non-availability of medicines Commission for the approval of institutions assigning preliminary approvals for scientific events Commission for the establishment of retail pharmacies and chambers of appeal (Frenchspeaking chamber and Dutch-speaking chamber) Commission for the recognition of pharmacists-clinical biologists Commission for the supervision of advertising for medicines for human use Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

Zowel voor well established use als voor traditional use werken fabrikanten volgens de " Good Manufacturing Practice " (GMP).
Que ce soit pour le well established use ou le traditional use , les fabricants procèdent selon les bonnes pratiques de fabrication (Good Manufacturing Practices ou GMP).

Zowel voor well established use als voor traditional use werken fabrikanten volgens de “Good Manufacturing Practice” (GMP).
Que ce soit pour le well established use ou le traditional use, les fabricants procèdent selon les bonnes pratiques de fabrication (Good Manufacturing Practices ou GMP).

Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines
Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines

Herbal medicinal products In line with the provisions of the royal decree of 14 December 2006, three procedures are used for the issue of the MA or registration for herbal medicinal products: the full procedure, the “Well Established Use” procedure and a third specific procedure for traditional herbal medicines as stipulated in article 43 of the royal decree.
Herbal medicinal products In line with the provisions of the royal decree of 14 December 2006, three procedures are used for the issue of the MA or registration for herbal medicinal products: the full procedure, the “Well Established Use” procedure and a third specific procedure for traditional herbal medicines as stipulated in article 43 of the royal decree.

Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission
Evaluation commission for active implantable medical devices Evaluation commission for homeopathic medicines Evaluation commission for medical devices Evaluation commission for medicines for human use Evaluation commission for medicines for veterinary use Evaluation commission for traditional herbal medicines Pharmacopoeia commission

De eerste aanvragen voor Traditional Use registratie (TU);
Les premières demandes d’enregistrement Traditional Use (TU) ;

De Europese regelgeving gaat er dus van uit dat voor traditional use voldoende lang gebruik zonder meldingen van toxiciteit de veiligheid garandeert.
La réglementation européenne estime donc que, pour le tradional use , un usage suffisamment long sans rapports de toxicité est un gage d' innocuité.

Indien er geen of onvoldoende klinische evidentie voorhanden is, spreekt men van traditional use of traditioneel gebruik: de hier gestelde indicaties beperken zich tot symptomen die de patiënt zonder al te veel risico’s kan behandelen; er zijn dus geen specifieke indicaties (ziektebeelden of risicofactoren).
Si les preuves cliniques dont on dispose sont insuffisantes ou inexistantes, on parle de traditional use : les indications proposées se limitent alors aux symptômes que le patient peut traiter sans trop de risques; il n’y a donc pas d’indications spécifiques (tableau clinique ou facteurs de risque).