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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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