News Archiv

Danish Medicines Agency updated information on the format and submission requirements for eCTD / NeeS and paper

The Danish Medicines Agency (DKMA) has restructured the information regarding submission format for paper applications and electronic drug applications in eCTD / NeeS format. In...[more]

New version of the "eValidator" released by BfArM

A new version of the "eValidator" eCTD / NeeS validation software used by German BfArM (developed by Lorenz Life Science, wwww.lorenz.cc) has been released. The new...[more]

Danish Medicines Agency will switch to electronic company authorisations by June 2011

The Danish Medicines Agency (DKMA) has announced that starting from June 2011, all company authorisations will  be issued in electronic form as a signed PDF file. Company...[more]

FI: Fimea reduces paper requirements for electronic submissions

The Finnish Medicines Agency Fimea announced today that the Agency started to accept electronic submissions for new applications as well as variations and renewals without...[more]

Irish Medicines Board updates Guide to electronic submissions

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

The new version 4 from March 10, 2011 reflects the fact...[more]

HU: Submission requirements updated by NIP

The Hungarian National Institute of Pharmacy (NIP) has updated their national submission requirements for medicinal products for human use. According to the new requirements, the...[more]

FI: FIMEA updates electronic submission requirements and mandates electronic submissions

The Finnish Medicines Agency FIMEA has published the requirements on electronic submissions of marketing authorisation material starting from the 1st of January 2011 (see...[more]