The Safety Features Delegated Act is a key element of the Falsified Medicines Directive. It was formally adopted by the European Commission on the 2nd October 2015 and was published in the Official Journal of the European Commission on the 9th February 2016.
The Falsified Medicines Directive
Before we look at the Safety Features Delegated Act, here is a recap of the key aspects of the Falsified Medicines Directive, which was first published on the 1st July 2011 by the European Commission.
As outlined in our blog, 'Traceability, Falsified Products and New Legislation', the Falsified Medicines Directive legislative measures include:
- An obligatory authenticity feature on the outer packaging of the medicines. This feature is further outlined in the Safety Features Delegated Act - with details below.
- A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union. In June 2014, the European Commission released the final draft of the logo that is to be used on all online pharmacies in the EU.[1}
- Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.
- Strengthened record-keeping requirements for wholesale distributors.
Details of the Safety Features Delegated Act
According to an article in Securing Industry, the act includes the following:
"The requirement for prescription medicines and select over-the-counter (OTC) drugs in the EU to carry a serialised unique identifier (UI) code within a 2D datamatrix barcode, anti-tampering device on the outer packaging, and verification of the UI at the point of dispensing.
It will apply to all EU member states apart from Italy, Belgium and Greece - which already have serialisation systems in place - as well as European Economic Area (EEA) countries Norway, Iceland and Liechtenstein plus Switzerland."
Unique Identifier Details
According to the European Commission;
"The composition, format and carrier of the unique identifier should be fully harmonised across the EU. The unique identifier should be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by member states), the batch number and the expiry date."
The Falsified Medicines Directive, including this delegated act, is expected to come into force on the 9th February 2019.
Preparation for the Safety Features Delegated Act
It is imperative that all those involved in the pharmaceutical supply chain, from manufacturers, to wholesalers, to distributors, to pharmacies, are aware of this impending legislation and if they have not already done so, they must begin to research, prepare and implement the necessary solutions to meet these legislative requirements.
Preparing for this legislative change will require substantial research, preparation, scoping, development, and implementation time, across a range of areas and stakeholders. Therefore, this complex process should be started sooner rather than later.
[i] European Commission: Health: Medicinal Products for Human Use: Falsified Medicines: Developments, [Online], Available From: http://ec.europa.eu/health/human-use/falsified_medicines/developments/index_en.htm, [Accessed: 01/09/2016]
[ii] Brentech Data Systems: Blog: “Traceability, Falsified Products and New Legislation” [Online], Available From: http://bds.ie/traceability-falsified-products-new-legislation/, [Accessed: 01/09/2016]/h6>
[iii] Brentech Data Systems: Blog: “The Falsified Medicines Directive: New Logo for Online Pharmacies” [Online], Available From: http://bds.ie/the-falsified-medicines-directive-new-logo-for-online-pharmacies/, [Accessed: 01/09/2016]
[iv] Securing Industry: Pharmaceuticals: “EC adopts Delegated Act on Safety Features” [Online], Available From: https://www.securingindustry.com/pharmaceuticals/ec-adopts-delegated-act-on-safety-features/s40/a2549/#.V8gS_FsrJD9, [Accessed: 01/09/2016]
[v] European Commission: Health: Medicinal Products for Human Use : Falsified Medicines, [Online], Available From: http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm, [Accessed: 01/09/2016]
[vi] Securing Industry: Pharmaceuticals: “Delegated Act published, sets clock ticking on safety features.” Available From: https://www.securingindustry.com/pharmaceuticals/delegated-act-published-sets-clock-ticking-on-safety-features/s40/a2674/#.V8g3cVsrJD8, [Accessed: 01/09/2016]