IMA accepts applications for MAs through CESP

As of 29 October 2012 applications for marketing authorisations and variations for human and veterinary medicinal products in the national, MR and DC procedures can be submitted through the Common European Submission Portal (CESP)

24.10.2012

As of 29 October 2012 applications for marketing authorisations and variations for human and veterinary medicinal products in the national, MR and DC procedures can be submitted through the Common European Submission Portal (CESP), either in eCTD or NeeS format.

CESP is a central submission file delivery system which can be accessed via http://cesp1.hma.eu/ where online registration, training guides and detailed FAQs are also available. It is a joint initiative of EU/EEA medicinal agencies and industry representatives, managed by the Heads of Medicines Agencies (HMA). Its aim is to simplify submissions of application documents by minimising the need for parallel submissions of CD/DVDs and paper copies.

The Icelandic Medicines Agency (IMA) encourages and supports the use of CESP. IMA does not request a signed paper original of cover letter when submitted through CESP.

Further information on registration and technical details of setting up the connections can be sent in English to cesp@hma.eu . Additional questions can also be addressed to lyfjastofnun@lyfjastofnun.is.