Gaois

A collection of legal and legislative terms in Irish extracted from the European Union’s multilingual terminology database. More information »

SOCIAL QUESTIONS|health|pharmaceutical industry
táirge íocshláinte cúntach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
ga
Hilfspräparat
de
auxiliary medicinal product | auxiliary medicinal products
en
Definition medicinal product used in the context of a clinical trial, but not as an investigational medicinal product Reference "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN"
Comment Auxiliary medicinal products do not include concomitant medications, i.e. medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
médicament auxiliaire
fr
Definition médicament utilisé dans le contexte d'un essai clinique, mais non comme médicament expérimental Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain