Vertaling van "authority for marketing " (Nederlands → Frans) :

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.

If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.
If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.

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.

In Europa wordt er een Market Authorization Application (MAA) aangevraagd bij het Europees geneesmiddelenbureau.
En Europe, une Market Autorisation Application (MAA) est demandée à l'Agence Européenne du Médicament.

Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific principles already in place in the European Union.
Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.

In September, the decision was made to withdraw a separate application for EU Marketing Authorization for Rasival, the combination of aliskiren and valsartan.
En septembre, la décision a été prise de retirer une demande d’autorisation de mise sur le marché dans l’EU de Rasival, une combinaison d’aliskirène et de valsartan.