News Archive

Lithuanian SMC switches to e-dossier only starting 01 May 2016

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Starting from the 1st of May, 2016, State Medicines Control Agency (SMCA) switches to e-submission (e-dossier) only. All applications for marketing authorization, renewal, all...[more]

National implementation of EU eSubmission roadmap - information from German BfArM and PEI


In line with the EU eSubmission roadmap that was adopted in November 2014, the German drug regulatory agencies BfArM and Paul Ehrlich Institute (PEI) have released corresponding...[more]

National implementation of EU eSubmission roadmap - information from UK MHRA and CZ SUKL


The EU eSubmission roadmap has already been adopted in November 2014 (see link here). One major objective of the eSubmission roadmap is to switch from paper to electronic format...[more]

New versions of electronic Application forms released

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New versions of the electronic application forms have been released. The update, dated 23 March 2015 concerns all forms available for human and veterinary products:

Initial MAA -...[more]

EMA updates information to PSUR repository, facing technical issues with some NAPs

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The European Medicines Agency has released new information related to the central PSUR Repository.

As part of the new information EMA announces that it will be mandatory to use...[more]

Poland starts CESP pilot

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The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has started a CESP Pilot Phase on December 15, 2014.

During the pilot phase...[more]

French ANSM updates national Notice to Applicants

La Tricolore

The French drug regulatory agency ANSM has released an updated version of their national Notice to Applicants, dated September 2014.

This guidance describes the submission...[more]

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