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Pharmaceutical wholesales are required to verify medicines that pass through their warehouses in specific circumstances, as set out in the Delegated Regulation. They also may have to decommission medicines supplied to certain customers such as dispensing doctors, nursing homes and prisons. Wholesalers in Croatia will have to adapt their software systems to create a connection to the HOPAL’s repository.

HOPAL is managing the onboarding process for wholesalers that connect to the HOPAL repository, but they are not required to pay any fees to HOPAL.

Please find detailed information regarding the obligations of wholesalers in accordance with the EU Directive 2011/62/EU on the EMVO website.

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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© 2018 HOPAL

Croatian Medicines Veryfication Organization
Radnička 80, 10000 Zagreb, Croatia
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