Decentralised Procedure Member States Standard

EMA pharmacovigilance system manual 12

by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. ... authorisation for medicinal products authorised through the mutual recognition or the decentralised procedure. ... standard operating procedures (SOPs) EMA pharmacovigilance system manual EMA/623550/2013 8

  States, Standards, Members, Procedures, Decentralised, Member states, Decentralised procedure

VOLUME 2A Procedures for marketing ... - European …

procedure of mutual recognition. The Member States concerned should then recognise the marketing authorisation already granted by the reference Member State and authorise the marketing of the product on their national territory. If no marketing authorisation has been granted in the Union, the applicant may make use of a decentralised procedure ...

  States, European, Members, Procedures, Decentralised, Member states, Decentralised procedure

Practical user guide for electronic Application ... - Europa

Page 4 of 83 Version Name Organisation 1.0 Representatives of NCA and EMA eAF Full Group, Representatives of NCA and EMA CMDh, Representatives of NCA and EMA CMDv 1.1 Representatives of NCA and EMA eAF Full Group, 1.2 Representatives of NCA and EMA eAF Full Group, CMDh and CMDv, eSub CMB 1.7 Representatives of NCA and EMA eAF Full Group, …