News and Educations

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 are 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 8 days from the release of this information.

Detailed information is available in the Medicines/Instructions for reporting varaiations in the documentation resulting from referral procedures/Levonorgestrel-containing medicines for urgent contraception section.