Manufacturers of pharmaceuticals in the UK will be required to ensure that the packaging of their products is tamper-proof, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed.

Under the plans, which seek to implement ‘safety features’ provided for in a delegated regulation made under the EU's Falsified Medicines Directive, an "anti-tampering device" will need to be fitted to packaging. The device would need to enable "verification of whether the packaging of a medicinal product has been tampered", the MHRA said in its consultation paper (24-page / 192KB PDF).

Plans to require the packaging of UK manufactured medicines to feature unique identifying information are also contained in the paper. This number will be contained in a 2D barcode containing the product code, serial number, batch number and expiry date.

"Our intention is to map products to UK NHS identifiers through the information that is already required to be uploaded by marketing authorisation holders into the pan-European Repository (European Hub)," the MHRA said.

The MHRA has proposed to allow pharmaceutical companies to include additional information in the 2D data matrix code if they wish.

Businesses that breach the new rules could be issued with written warnings, stop notices, fines and even criminal penalties, according to the plans. The MHRA's proposals are subject to consultation until 23 September.

The delegated regulation comes into force on 9 February 2019. It will have direct effect in the UK and will apply despite the vote for Brexit.

According to figures from the European Union Intellectual Property Office (EUIPO), drugs companies in the EU lose more than €10 billion every year as a result of counterfeit medicines.

"Despite some concerns from manufacturers about the cost burden of implementing these measures, it is clearly beneficial to seek to stop falsified medicines entering the legitimate supply chain," said Catherine Drew, a regulatory expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com.

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