An example for retriving reference medicinal products for marketing authorisation application of generic medicinal products in the EU
XU Ming-di
NIU Jian-zhao
YANG Dong-sheng
LI Tao
QIAO Li-tao
GAO Tian-tian
Abstract：The European Union (EU) is a unique alliance composed of multiple member states,and diverse routes can be used for the marketing application of medicinal products,thus there is no comprehensive medicinal product list at present to include the entire marketed medicinal products in the EU.To facilitate the searching and identification of reference medicinal products used in supporting a marketing authorisation application in the EU,the websites and contact information of the drug regulatory authorities for the EU and its member states were summarized in a table.And by taking the mifepristone tablets (200 mg) as example,the searching and identification of its reference medicinal product used in supporting a marketing authorisation application in the EU was illustrated with the combination search in three marketed medicinal product lists,such as Community Register,MRI Product Index and Approved Drug Products list in each member state of the European Union.
Keywords：European Unionreference medicinal productEuropean Medicines Agencyco-ordination group for mutual recognition and decentralised procedures of drugs for human usemifepristone tablet
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 26-30 )