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Europe introduces rules to fight falsified medicines

New safety measures are to be introduced to the packaging of medicine in Europe, including a unique identifier and tamper-evident features. 12 Feb 2016

The European Parliament has approved and published regulations that build on the Falsified Medicines Directive in helping to verify and secure medicines along the supply chain.

A barcode acting as a unique identifier will be added to all medical products, along with human-readable information, by the manufacturer. This will be scanned at fixed points along the supply chain, and linked to a repository system to check the identity of the product.

Packaging will also now includes features that make it obvious if the product has been tampered with.

Falsified medicines are medicines with false sources such as names or ingredients; histories, such as batch numbers, or false source information. 

These medicines may contain low quality ingredients, or the wrong dosage or component  ingredients, or may even be entirely counterfeit with no active pharmaceutical ingredients, and can thus be a major health threat, said intellectual property expert Louise Fullwood of Pinsent Masons, the law firm behind Out-Law.com.

"This move is welcome. It supplements the Falsified Medicines Directive with practical details, and will improve the safety reputation of the industry," Fullwood said.

"The barcodes will make substitution and falsification of medicines harder, and will also make it easier to track a batch of medicine that turns out to be non-compliant," Fullwood said.

The move will add some costs for smaller manufacturers, Fullwood said, but it has been discussed for some time and should not come as a surprise.

"There is also a substantial time period for manufacturers to introduce any new technology and processes before this comes into force," she said.

The delegated regulation comes into force in the UK on 9 February 2019.

The new packaging features are also likely to reduce IP infringements in medicine, Fullwood said.

The European Commission published draft regulations on medicine packaging in September 2015. Falsified medicines have been found in all areas of the supply chain, legal and illegal, prescription and over-the-counters, and in both branded and generic medicine, the Commission said at the time.

An impact assessment run by the Commission looked at the benefits, costs and cost-effectiveness of the proposal, at the technical options for the identifier, at how authenticity would be verified, and at how the repository system would be managed, it said.

It was decided that the unique identifier should be the same across the EU, and placed in a 2D barcode containing the product code, serial number, batch number and expiry date.

Medicines should be systematically verified by pharmacies before being supplied to the public, and those at higher risk should also be checked by wholesalers.

Steps should also be taken to make sure that personal data is protected, although the initial proposal does not involve any personal data being stored in repositories, the Commission said.

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