News Archive

EMA mandates eSubmission Gateway or web client for eCTDs in the Centralized Procedure

10.02.2014
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The European Medicines Agency (EMA) reminds Marketing Authorization Holders and Applicants in a recent press release that beginning March 01, 2014 all eCTD submissions must be...[mehr]

EMA updates Pre-authorization Procedural Advice

10.02.2014
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The European Medicines Agency has released an updated version of their "Pre-authorisation procedural advice for users of the centralised procedure", dated February 2014...[mehr]

New versions of the EU electronic Application Forms released (MAA, variation, renewal)

06.02.2014
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The electronic Application Forms for Human Medicinal Products have been updated. The update comprises the forms for

Initial MAAVariationsRenewals

and includes for each of the...[mehr]

CMDh releases new submission requirements for MRP, DCP and national procedures

06.02.2014
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Updated versions of the submission requirements overview tables have been released by the CMDh summarizing the national submission requirements of the EU/EEA Member States for...[mehr]

EMA encourages applicants to submit quality Type I variations for 2013 by end of November

22.10.2013

The European Medicines Agency (EMA) is advising marketing-authorisation holders to submit any quality type-IAIN and type-IA variations for 2013 by Friday 29 November wherever...[mehr]

Registration procedures for EudraVigilance changed for MAHs and Sponsors, new instructions for virtual affiliates

18.07.2013
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The EudraVigilance registration procedures for Marketing Authorisation Holders (MAHs) and Sponsors have changed. Additional requirements and updated registration forms have...[mehr]

EDQM releases new version of the guidance for electronic and paper submissions for CEP applications

11.07.2013
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The EDQM has released a revision of their "Guidance for electronic and paper submissions for Certificates of Suitability (CEP) applications". The revised document...[mehr]

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