Updated versions of variations and renewal application forms*

Updated versions of variations and renewal application forms*

In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of electronic application forms * This post has been marked […]

Updated Application Form*

Updated Application Form*

The new revised version 10.1 of the administrative information application form was published by the European Commission (Notice to applicants, medicinal products for human use, volume 2B, module 1.2). Marketing authorisation applicants shall use this form as from 3 June 2013, but may use it even before. The electronic version is also available from May […]