News & Events
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CATEGORIES
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News & events
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Notification to Marketing Authorization Holders on the Amount of the Annual Fee and Access Fee for 2026
The Croatian Medicines Verification Organization informs marketing authorization holders, who are obliged to pay the annual fee and access fee to HOPAL…
EUROPOL report: Digital platforms increasingly used to trade counterfeit medicines in Europe
This report outlines the threat of pharmaceutical crime in the EU and beyond, as assessed by Europol….
Celebrating 6 Years of the EMVS
On 9 February 2025, the European Medicines Verification System (#EMVS) marks 6 years of safeguarding the supply chain and protecting patient safety….
Amount of the annual fee for 2025.
HOPAL determined the amount of the annual fee for the Croatian Medicines Verification System usage by MAHs. Croatian Medicines Verification Organization – HOPAL, based on the HALMED’s (Croatian Agency for Medicinal Products and Medical Devices) official list of MAHs whose medicinal products are in the scope of FMD legislation…
Incident – System interruption
On 15.03.2021. at 8:00 p.m. an incident occurred on the basis of drug serialization data, both in the Republic of Croatia and in other 12 EU countries…
Extension of the transitional operational period
The Ministry of Health issued a consent to extend the transitional operational period of the Croatian Medicines Verification System until December 31st, 2019…
Guidelines for EMVO and NMVO stakeholders
The following guidelines reflect the best effort and thinking of stakeholder experts with the information available to them, on 29 January 2019…
Media Release
Croatia has duly established an end-to-end medicines verification system which provides an assurance of safe medicine supply to the patient…
Letter to stakeholders
A key measure to address falsification in the EU and protect the legal supply chain of medicines is an end-to-end verification system introduced by the Falsified Medicines Directive (FMD). The end-to-end verification is a medicines authentication system including mandatory safety features and a repository that stores information on each individual pack.
Amount of the annual fee
HOPAL determined the amount of the annual fee for the Croatian Medicines Verification System usage by MAHs. Croatian Medicines Verification Organization – HOPAL, based on the HALMED’s (Croatian Agency for Medicinal Products and Medical Devices) official list of MAHs whose medicinal products are in the scope of FMD legislation…