News Archive

CMDh releases updated submission requirements (number and format)

14.11.2014
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Updated submission requirements were released by the CMDh for applications within MRP, DCP or National procedures. 

The submission requirements overview tables, dated...[mehr]

EMA releases another update of the Pre-Authorisation Procedural Advice for CP users

06.11.2014
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A new update of the "Pre-Authorisation Procedural Advice" for users of the Centralized Procedure (Medicines for Human Use) has been released.

The new version, dated...[mehr]

EMA updates Dossier requirements

13.10.2014
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EMA has released some updates to their "Dossier requirements for Centrally Authorised Products". The new updates released in October address the fact that Hungary and...[mehr]

EMA updates Pre-Authorisation Procedural Advice for CP users

09.10.2014
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EMA has released another update of the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" (EMA/339324/2007).

The new...[mehr]

Update! - Electronic application forms updated

02.10.2014
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!Update from 02 October 2014!

Meanwhile a new minor version (Release note version 1.16.0.1) has been released for all that addresses a critical issue in version 1.16.0.0 that...[mehr]

EU Telematics Management Board releases new strategy paper 2014 - 2016

01.10.2014
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The EU Telematics Management Board has released a new strategy paper: "EU Telematics Strategy 2014 - 2016".  New governance structures were put in place in 2013 to...[mehr]

EDQM releases updated application forms to be used from 01 October

26.09.2014
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The European Directorate for the Quality of Medicines & Healthcare (EDQM) has released updated versions of the application form required for requests for certificates of...[mehr]

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