New rules pertaining to drug marketing authorisation applications in Slovakia

2010-01-20

The Slovak medicines agency (SUKL) has introduced changes to its electronic application submission system, known as e-Ziadost, the use of which, from January 2010 onwards, will be obligatory in applying for new marketing authorisations.
The system has been changed in order to comply with EU Regulation 1234/2008 pertaining to the examination of amendments to drug marketing authorisations. All marketing authorisation and amendment dossiers submitted and accepted by the SUKL before the end of 2009 will be examined by the authority in accordance with EU provisions which were binding until the end of 2009. However, any applications submitted before the end of 2009 which were incomplete, and therefore rejected by the SUKL, should be resubmitted, by means of the updated system.
The SUKL has also published, on its website, guidelines pertaining to the amended variation procedure and an application form in the Slovak language.