News Archiv

BfArM widens scope for accepting electronic-only submissions

27.09.2012
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The German Federal Institute for Drugs and Medical Devices (BfArM) will widen it's scope for accepting electronic-only submissions for human medicines starting October 08 this...[more]

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UK MHRA releases new website section on making licence submissions

11.07.2012
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The British Medicines and Healthcare products Regulatory Agency (MHRA) has released a new website section "Submitting an application to the MHRA" that sets out the MHRA...[more]

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Spanish Medicines Agency updates national electronic submission guidance

29.05.2012
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The Spanish Medicines Agency "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" has released an updated version 2.2 of their national electronic...[more]

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Irish Medicines Board updates Guide to electronic submissions

14.05.2012
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The Irish Medicines Board (IMB) has updated the national "Guide to electronic Submissions - Human Medicines"

The new version 5 from May 14, 2012 has been...[more]

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UK MHRA details technical validation process for eCTDs

26.01.2012
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The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has released some information regarding the technical validation of electronic Marketing Authorisation...[more]

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French Afssaps issues new version of their national Notice to Applicants

04.01.2012
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The French Drug Regulatory Agency Afssaps has released an updated version of their national "NOTICE TO APPLICANTS FOR MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR...[more]

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BE: Update of the national eSubmission Guideline and corresponding NeeS checker

05.12.2011
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The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic...[more]

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