Instructions for variation application in the medicinal product dossier as a result of a referral procedure
22.09.2014
The European Commission adopted on 4th September 2014 the Decision on marketing authorisations for human medicines acting on the renin-angiotensin system, under Article 31 of the Directive 2001/83/EC of the European Parliament and the Council (procedure number EMEA/H/A-31/1370). Detailed information on this decision are available on the European Commission’s webpages, or here.
The mandatory reporting of variations in the dossier to HALMED concerns all medicinal products authorised via national procedure in Croatia that belong to the pharmaco-therapeutic group of medicines acting on the renin-angiotensin system (ATC code: C09) and containing the following active substances: enalapril, fosinopril, lisinopril, trandolapril, perindopril, ramipril, cilazapril, quinapril, zofenopril, losartan, valsartan, eprosartan, temisartan, irbesartan and candesartan.
HALMED calls upon all marketing authorisation holders in Croatia to submit as soon as possible the variation application to the dossier for medicines containing these active substances, taking account that the deadline for variation implementation in the summary of product characteristics and package leaflet is 30 days from the date of the Commission’s Decision.
Detailed information is accessible on the HALMED webpages in the Medicines/Instructions for variation applications in the medicinal product dossier as a result of a referral procedure for medicines acting on the renin-angiotensin system, or here.
