Preferred Label : Reference Member State;
NCIt synonyms : RMS;
NCIt related terms : reference member state (RMS);
NCIt definition : A European Economic Area country with marketing authorization for a medicinal product
that evaluates the marketing authorization application dossier and prepares the assessment
report on behalf of another European Economic Area country that is seeking to obtain
marketing authorization for the same product through Mutual Recognition or Decentralized
procedures.;
Alternative definition : CDISC-GLOSS: A classification of a Member States in the Mutual Recognition Procedure
(MRP) in the European authorization route resulting in a mutually recognized product.
The first Member State that has authorized the product in the RMS. [After Heads of
Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem .html]
See also Mutual Recognition Procedure (MRP) and Concerned Member State (CMS).;
NCI Metathesaurus CUI : CL935694;
Origin ID : C156641;
UMLS CUI : C4722663;
Semantic type(s)
- concept_is_in_subset
