Notice to applicants for variation applications to the medicine’s documentation pursuant to the referral procedure for adrenalin (epinephrine) –containing medicines
The European Commission adopted on 14 August 2015 Decision on marketing authorisations for human medicines for adrenalin (epinephrine)-containing medicines for auto-injection within the framework of Art. 31 of Directive 2001/83/EC of the European Parliament and Council (Procedure No EMEA/H/A-31/1398). Detailed information on this Decision are accessible on the European Commission website.
HALMED invites all marketing authorisation holders in the Republic of Croatia for adrenalin (epinephrine)-containing medicines for auto-injection to submit in the shortest time an application for variation to the medicine’s documentation.