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Extension of the transitional operational period of the Croatian Medicines Verification System until December 31st 2019.

July 19, 2019

The Ministry of Health issued a consent to extend the transitional operational period of the Croatian Medicines Verification System until December 31st, 2019. The decision was made due to the lack/ insufficiency of data regarding medicinal products labelled with safety features in the System, which generates a large number of “false” alerts.

During the transitional period, the pharmacies will verify the authenticity of the medicines in accordance with the applicable regulations but will deliver the medicine to the patient as per the existing procedure, irrespective of the triggered alerts. HOPAL will investigate the cause of alerts and all the potential incidents of falsification.

The aim of the transitional period is to facilitate an uninterrupted work of pharmacies and regular supply of medicines to patients and is in line with the recommendations of the European Medicines Verification Organisation (EMVO).

Please note that this transitional period refers exclusively to the procedures in public and hospital pharmacies, while the other stakeholders in the medicines supply chain (manufacturers, distributors, wholesalers, marketing authorization holders, etc.) are obliged to continue fulfilling all their obligations in accordance with the Falsified Medicines Directive (Directive 2011/62/EU) and the Commission Delegated Regulation (EU) 2016/161.

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).

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Amount of the annual fee

HOPAL determined the amount of the annual fee for the Croatian Medicines Verification System usage by MAHs
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The Croatian Medicines Verification Organisation (HOPAL) is a non-profit organisation representing the different stakeholders, both...
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Croatian Medicines Veryfication Organization
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