News Archiv

DE: BfArM released new version of their eCTD/NeeS Validator

A new version of the "eValidator" (by Lorenz, www.lorenz.cc) used for the validation of eCTD/NeeS has been released for download by the German BfArM today.

This new...[more]

Update SI: JAZMP publishes e-submission requirements - EN version available

Update from 26-April-2010:

The requirements for electronic submissions in Slovenia have now been released additionally in English language by the Slovenian agency JAZMP. Please...[more]

FI: FIMEA published electronic submission roadmap

The Finish Drug Regulatory Agency Fimea will accept marketing authorisation applications in electronic format starting from June 01, 2010. Fimea has been making...[more]

DE: BfArM publishes Q&A to electronic submission requirements

The German Federal Institute for Drugs and Medical Devices (BfArM) has posted some Q&A regarding their newly published requirements for electronic submissions. Questions...[more]

DE: German BfArM publishes eSubmission requirements

The German Federal Institute for Drugs and Medical Devices (BfArM) will accept to receive nearly paperless electronic-only submissions starting from 31. March 2010 onwards....[more]

DE: BfArM publishes announcement regarding electronic-only submissions

!Updated 01-Mar-2010!

Today the German drug regulatory agency BfArM published an announcement detailing the plans for accepting electronic-only submissions for medicinal products...[more]

UK: MHRA publishes new FAQ section wrt the new Variation Regulation

An FAQs section (see link below) has been added to the MHRA website to help submit and amend variations to licences under the new Variations Regulation, which was introduced in...[more]