Instructions for application of variations resulting from the referral procedurefor bromocriptine containing medicines
18.11.2014
The European Commission endorsed on 30 October 2014 Decision on marketing authorisations for bromocriptine-containing medicines, under Article 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1379). Details are available on the European Commission’s webpages, or here.
HALMED is inviting all marketing authorisation holders in the Republic of Croatia for bromocriptine-containing medicines (listed in Annex I to Commission’s Decision) to submit a variation application in the medicine’s documentation within 7 days from the release of information.
The text that should be included in the summary of product characteristics and package leaflet is published in Annex III to Commission’s Decision.
According to current guidelines for classification of variations, the variation should be classified as IA C.I.1.a (if it is about including an agreed text published in Annex III to Commission’s Decision), or IB C.I.1.a (if the change in the summary of product characteristics and package leaflet requires harmonisation of respective parts of the SmPC and/or PL.
