Background

Better protection against falsified medicinal products

The three-year transitional period for the implementation of EU-wide serialisation and verification requirements for prescription-only medicinal products started with the publication of Delegated Regulation (EU) 2016/161 in February 2016. Strict requirements for safety features on medicinal product packs will apply as of 9 February 2019.

EU Directive for better traceability en route from manufacturers to pharmacies

To make prescription-only medicinal products safer is the objective of the Falsified Medicines Directive (2011/62/EU). The Directive relating to the “prevention of the entry into the legal supply chain of falsified medicinal products” provides for the introduction of new safety features on medicinal product packs.

Thanks to these safety features, tampering with the packaging can instantly be detected and medicinal products can be traced all along their way from manufacturers to pharmacies.

 

Implementation of the system in the EU

EMVO (European Medicines Verification Organisation) is responsible for implementing the system called for by the Falsified Medicines Directive.

 

 

32

countries have to set up a serialisation and verification system for medicinal products.

2,500

pharmaceutical manufacturers must be connected to a single system.

1,000+

medicinal product wholesalers and pharmacies have to adapt their operations accordingly in order to achieve this goal.

10.5 bn

packs per year have to be equipped with safety features throughout the EU.

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AMVO - Austrian Medicines Verification Organisation
Operngasse 6/6, 1010 Wien