Medicines Verification System

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Safety features

Medicines placed on the market from February 2019 will have the following ‘safety features’:

1. An anti-tamper device (similar to what you would see on a milk carton) so the person supplying it be sure it hasn’t been interfered with. Such devices are already common on many medicines but will be mandatory for most medicines in future.

2. A special 2D barcode containing information about the medicine, known as unique identifiers. Embedded in this barcode will be a product code, serial number, batch number and expiry.

Detailed technical requirements for unique identifiers and the databases or ‘repositories’ where they will be stored are set out the Commission Delegated Regulation (EU) 2016/161 (also known as the ‘Delegated Regulation’).

The Delegated Regulation set an implementation deadline of 9th February 2019 and manufacturers must ensure medicines released to the market after this date have the required safety features.

For more information please read EMVO’s document Safety Features for Medicinal Products for Human Use.

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
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