News Archive

New version of the eAF Data Exchange Standards released

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New versions of the Date Exchange Standards (DES) for the electronic Application Forms (eAF), dated 5 May 2014, have been released on the EMA eSubmission website. The DES was...[mehr]

Updated Q&A, defects and workaround solutions, Hotfix for eAF released

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A new hotfix version for the electronic Application forms

Marketing Authorization Application - HumanMarketing Authorization Application - VeterinaryVariation

has been...[mehr]

EMA updates dossier requirements for centrally authorised human medicinal products

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The European Medicines Agency has released a further update of the "Dossier requirements for centrally authorised products". The new revision 7 from 01-April-2014...[mehr]

EMA updates Post-Authorization Procedural Advice and some Q&As

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The European Medicines Agency has updated it's "Post-authorisation procedural advice for users of the centralised procedure" with a new release Rev39, dated April 2014...[mehr]

EMA changes handling of certain evaluation procedures from 01 April 2014

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As part of the ongoing reorganization of the European Medicines Agency (EMA), the Agency will change the handling of the following regulatory procedures starting 01 April...[mehr]

CMDh updates country requiremens for new applications and lifecycle submissions

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New country requirements for electronic submissions for MRP/DCP and national procedures have been released on the CMDh website.

Corresponding requirements were updated for new...[mehr]

CMDh updates several Q&A documents

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The Co-ordination Group for Mutual Recognition and Decentralized Procedures - CMDh has released updated versions of the following three Q&A documents:

Applications for...[mehr]

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