Levonorgestrel - Containing Medicines for Emergency Contraception
Instructions for reporting variations in the documentation for medicinal products resulting from referral procedures for levonorgestrel-containing medicines for emergency contraception
The European Commission adopted on 30 September 2014 Decision on marketing authorisations for human medicinal products containing levonorgestrel, pursuant to Article 31 of Directive 2001/83/EC of the European Parliament and Council (Procedure number EMEA/H/A-31/1391). Detailed information on this decision is available on the European Commission's webpages.
HALMED calls upon all marketing authorisation holders in the Republic of Croatia for medicinal products belonging to the pharmaco-therapeutic group of emergency contraceptives and containing levonorgestrel (listed in Annex I of Commission's Decision) to submit a variation application within eight days from the release of this information.
The text to be included in the summary of product characteristics and package leaflet is published in the Annex III of the Commission's Decision.
According to current guidelines on classification of variations, the variation should be classified as IA C.I.1.a (if it is about including the agreed text published in Annex III of Commission's Decision), or IB C.I.1a (if data modification in the summary of product characteristics and package leaflet requires harmonisation of the respective parts of the summary of product characteristics and package leaflet).