EU delegated act on safety features published

EU medicineA draft of the EU delegated act on safety features - a key part of the Falsified Medicines Directive - has now been published.

The long-awaited document covers the technological and organizational requirements for obligatory security features that will have to be added to prescription medicine packs when the FMD (Directive 2011/62/EU) comes fully into force.

The 34-page document details the technical specifications for the unique identifiers added to packs, the way these should be verified, and the data repository that will be used to store them.

At first glance these seem to be as expected. The unique identifier is proposed as a 2D bar code carrying a serial number, product code, batch number and expiry date - with a national reimbursement number is required - added to the medicine pack by the manufacturer and verified on dispensing to the patient.

The repositories system containing the unique identifiers should be set up and managed by stakeholders - with national regulatory authorities able to access and supervise the system, it says.

Once again, that seems to be in alignment with the European Stakeholder Model (ESM) proposed by groups representing the pharma industry, wholesalers, pharmacists and parallel importers, although additional analyses and reaction will be published in a follow-up article.

The draft is published alongside annexes that detail the 'white list' of prescription medicines exempted from the safety features, as well as the 'black list' of non-prescription drugs that should bear them because they are deemed at elevated risk of falsification.

It also covers the notification and evaluation procedures for prescription medicines that the sponsor would like to be exempted, or indeed non-prescription medicines that should be included in the scope of the act on a risk basis.

Commenting on the publication - German medicine verification group securPharma - which is linked to the European Medicines Verification System (EMVS) being developed by the ESM partners - said the initial impression is that its platform is "well prepared and on track" to meet the requirements of the act.

The text still has to be forwarded to the European Parliament and Council for review before it can be finalised and published in the Official Journal of the EU, which is now expected to take place in the first quarter of 2016. It will come into full force three years after publication, according to the draft.

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