SOCIAL QUESTIONS|health|health policy · TRADE
- seoladh ar an margadh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- market launch | to launch on the market
- en
- Definition placing of a medicinal product1 on the market after a marketing authorisation2 has been granted (either at EU level or national level), or for medical technologies (i.e. medical devices3, in vitro diagnostics4), once the CE marking is in place 1 medicinal product [ IATE:1443220 ] 2 marketing authorisation [ IATE:1589658 ] 3 medical devices [ IATE:1442463 ] 4 in vitro diagnostics [ IATE:886911 ] Reference COM-Terminology Coordination, based on:European Commission. DG Health and Food Safety (SANTE). Correspondence dated 25.1.2018
- Comment It normally happens at Member State-level following the conclusion of pricing and reimbursement negotiations or when these are at an advanced stage. Market launch can subsequently occur in other Member States. See also: placing on the market [ IATE:933922 ]
- lancement sur le marché
- fr
- Definition mise sur le marché d’un médicament après qu’une autorisation de mise sur le marché a été accordée (au niveau de l’Union européenne ou au niveau national) et, pour les dispositifs médicaux, après que le marquage CE a été apposé Reference COM-FR, d’après la proposition de règlement du Parlement européen et du Conseil concernant l’évaluation des technologies de la santé et modifiant la directive 2011/24/UE (COM/2018/51 final), CELEX:52018PC0051/FR [13.2.2018]
- Comment Voir aussi:- mise sur le marché [IATE:933922 ] - médicament [IATE:1443220 ] - autorisation de mise sur le marché [IATE:3535604 ] - dispositif médical [IATE:1442463 ]