Falsified Medicines Directive Implementation in the Baltics

Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 – “the Delegated Regulation”) may have impact on the product information and the marketing authorisation dossier.

In particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an antitampering device (ATD), on the packaging of prescription medicines and certain non-prescription medicines for the purposes of authentication and identification. As a result, the EMA and the QRD Group have revised the Human PI templates and Marketing Authorization Holders are encouraged to use a subsequent regulatory procedure affecting the Product Information (e.g. Renewal, Variation II, Variation IB, Variation IA) to provide an updated version of the QRD template confirming the implementation of the safety features in the product information.

Another new feature introduced by this Directive is the EU storage system containing information about security measures. The storage system will be composed of central and national accumulators in the Member States. 2015 The EU has set up the European Medicines Verification Organization, which is responsible for the establishment of a central storage system, and the Baltics States have set-up the relevant national bodies:

The national bodies will store product and packaging data, handle requests for pharmacies and wholesalers to verify and change the status of medicines, and reconcile data with the central EU system. Marketing Authorization Holders will have to register within national systems and pay the relevant fees to the national bodies. However, currently the registration is not yet launched in any of the Baltic bodies.

More info about the national systems on top of EU system, can be found here: https://emvo-medicines.eu/home/mission/emvs/

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