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Falsified medicine regulation comes in law

11 Feb 2019 / legislation Print

Falsified medicine regulation comes into effect

An EU Regulation with measures to combat the risk of falsified medicines entering the supply chain has been signed into law by the Minister for Health Simon Harris.

All parts of the European supply chain for medicines must comply with the new legally binding rules.

The Minister has welcomed the implementation 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 requires all pharma companies to put a unique 2D barcode and an anti-tampering device on packs of prescription medicines for the EU market.

In 2016, more than 600,000 dosage units of false or substandard medicines were detained by Irish authorities, Irish Pharmacy News reports.

Globally, up to 10% of medicines are substandard or falsified. In Africa and Asia, that figure rises to 42%.

The WHO stopped the term “counterfeit” in 2017 and substituted the phrase “substandard or falsified”. This broader definition captures products which may have legitimate ingredients but have incomplete, missing or falsified paperwork.

Counterfeit

The word ‘counterfeit’ means a trademark violation under trade rules on intellectual property.

However, authorities are adopting a “pragmatic approach” to the new regulation and will allow the new system to bed in before taking enforcement action.

During the initial period of operation, the system will be considered to be in “use and learn” phase.

From this month, anyone supplying medicines to patients must verify that the safety features of those medicines are in place by scanning the 2D barcode and checking the integrity of the anti-tamper device. 

Patient safety

Minister 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. 

“While there has been no risk or reported incidents to date at pharmacy level from fake medicines in Ireland, other European countries have had issues. This new national system provides further security and protection for Irish and European patients now and into the future." 

While stakeholders develop a clear and robust alerts management system, no offences provisions will be introduced and no enforcement action will be taken by regulatory authorities.

Compliance

Stakeholders must, however, take all steps necessary to ensure compliance with the EU Regulation, the Department of Health has said.  Enforcement provisions will be introduced later this year. 

The Irish Medicines Verification Organisation (IMVO) has been established 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. 

Significant

Leonie Clarke of the IMVO said “This new medicines’ verification system, is a significant undertaking involving the collaboration of almost 2,000 pharmacies and hospitals, along with pharmaceutical manufacturers and wholesalers, stakeholder representatives and regulators, which sees over 95 million prescription medicines dispensed to patients every year. 

“The new national system provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.” 

Gazette Desk
Gazette.ie is the daily legal news site of the Law Society of Ireland