News Archive

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...[more]

Electronic submission of information on human medicines authorized in Croatia

01.07.2013
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In a recent press release, the Croatian Drug Regulatory Agency Halmed reminded Marketing Authorisation Holders of Human Medicines authorized in Croatia of their obligation to...[more]

Registration procedure for EudraVigilance updated

16.05.2013
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The following updates regarding the Registration with EudraVigilance have been announced by the European Medicines Agency:

Virtual affiliate Registration: New instructions...[more]

EMA announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements

06.07.2012
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The European Medicines Agency (EMA) has announced next steps for the maintanance of information on medicines in accordance with mandatory Article 57(2) requirements. On 28 June...[more]

EMA updates XEVPRM FAQ

21.06.2012
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The European Medicines Agency has released an updated version of the XEVPRM FAQ, document EMA/945380/2011. The new version, dated 21 June 2012 has no version number and includes...[more]

EMA releases further updated XEVMPD controlled vocabularies for Substances and Organisations

29.05.2012
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The European Medicines Agency (EMA) has released further updated versions of the following XEVMPD controlled vocabularies:

Organisations (WC500123647), version 4.0Substances...[more]

EMA launches XEVMPD e-learning course to support Article 57(2) compliance and further updates XEVMPD controlled vocabularies

21.05.2012
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The European Medicines Agency (EMA) has launched the long-awaited XEVMPD e-learning course to support compliance of Marketing Authorisation Holders (MAHs) with Art. 57 (2) of...[more]

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