Medicines Acting on the Renin Angiotensin System
Instructions for variation applications in the medicinal product dossier as a result of a referral procedure for medicines acting on the renin-angiotensin system
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 is 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.
Under Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures, izmjenu je potrebno klasificirati kao IA C.I.1.a (ako se radi o uvrštavanju dogovorenog teksta objavljenog u Dodatku II Odluke Europske komisije ), odnosno IB C.I.1.a, ako izmjena podataka u sažetku opisa svojstava lijeka i upute o lijeku zahtijeva prilagođavanje odgovarajućih dijelova sažetka i/ili upute (npr. uklanjanje navoda koji su u očitoj suprotnosti s izmjenom koja se uvrštava, manje jezične izmjene, mijenjanje rečeničnih konstrukcija i općenito formatiranja odlomka ili poglavlja).
The text should be included in the summary of product characteristics and package leaflet published in the Annex II of the Commission's Decision, or here.
Taking account that the referral procedure ended up with the Commission's Decision, changes in respective parts of the summary of product characteristics and package leaflet must be identical to those indicated in the Annex II of the Commission's Decision.
In order to comply with the referral procedure outcome, the variation in the medicinal product's dossier should be reported for all medicinal products containing the active substances encompassed by the Commission's Decision independently from other pending regulatory applications (renewals, upgrading or variation) or their scheduled submissions.