‘Falsified Medicines Directive’ – Ireland introduces new rules to regulate the supply chain of counterfeit medicinal products

Author: Aaron Kelly, Hannah Unger, Eimear Burke

February 19, 2019

As of 9 February 2019, Ireland has committed to the application of the EU Commission Delegated Regulation (EU/2016/161) on Safety Features on medicinal products as part of the EU Falsified Medicines Directive (the “Regulation”)

The safety features ushered in under the new Regulation comprise two elements placed on the packaging of a prescribed medicinal product for human use:

  1. A unique identifier comprising a two-dimensional barcode allowing for identification and authentication; and
  2. An anti-tampering device.

Patient Safety

The Regulation is set to combat the risk of falsified medicines entering the market. It will fall to pharmaceutical companies to ensure they are in line with the Regulation. Accordingly, health care professionals supplying medicines to patients must verify that the safety features of those medicines are in place by scanning the barcode and checking the integrity of the anti-tamper device.

Speaking before the regulation came into effect, Minister Simon Harris said “These new requirements will enhance patient safety by protecting the medicines supply chain from infiltration by counterfeit medicines and introducing new rules to more rigorously regulate the supply chain.”

Regulation / Compliance

The Irish Medicines Verification Organisation (IMVO) has been set up to manage the medicines verification system for Ireland.

The Department of Health has been working closely with the IMVO, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) for the last year to monitor progress in the implementation of the new safety feature requirements.

During the initial period of operation, the system will be considered to be in “use and learn” phase. This will allow stakeholders to familiarise themselves with the system and to develop an active alerts management system with clarity.

No enforcement action will be taken at this time as the system remains in its infancy. Enforcement provisions will be introduced later this year. Stakeholders must, however, take all steps necessary to ensure compliance with the EU Regulation. If a stakeholder suspects an issue, based on an examination of the anti-tamper device, they must report their concern to the Health Products Regulatory Authority.

The implementation of this Regulation is likely to bolster the public’s confidence in the medicines they receive. The full text of the Regulation can be accessed here.

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