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Oct 14, 20231 min read

EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure

Yesterday (13 October 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency post-authorisation...

Oct 1, 20231 min read

EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...

Apr 29, 20231 min read

EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure

Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...

Nov 4, 20221 min read

EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure

Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...

Oct 13, 20221 min read

EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

Mar 23, 20221 min read

EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...

Nov 14, 20211 min read

Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA

This guidance document addresses a number of questions that marketing authorisation holders (MAHs) may have on post-authorisation...

Jul 29, 20211 min read

Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA

This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...