News about GMP/cGMP

26.11.2021

EMA: Revision of Q&A on pre-authorisation of centralised procedures

EMA: Revision of Q&A on pre-authorisation of centralised procedures

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".


Important to know: A registration and use of the "OMS, Organisation Management Service", has been obligatory since 1 November 2021. Registration is a must before submitting of any application for admission.

Which questions are new or have been updated?

All revised questions concern section 2 "Steps prior to submitting the application":

  • 2.2 How and when should the eligibility request be sent to EMA?
  • 2.4 What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?
  • 2.6 When should I submit my marketing authorization application?
  • 2.7 How should I notify a change in the contact person and/or intended submission date of my application?
  • 2.8 Is my product eligible for an accelerated assessment?
  • 2.9 How are marketing authorisation application pre-submission interactions structured at the EMA?

Source:

EMA: Q&A for users of the centralised procedure

EMA: QMS


 

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