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    Friday, 27 July 2018 16:08
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    Friday, 27 July 2018 15:58
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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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EuroUnionFebruary 17 2016

Further measures to improve safety and protect against fake or falsified medicines entering the supply stream have been approved in Europe.

Last week’s European Parliament vote has added two requirements to the Falsified Medicines Directive regulations:

  • a 2D matrix code and human readable information must appear on medical products allowing the items to be scanned and verified at various points in the supply chain
  • packaging will also have to include tamper evident features.

Manufacturers now have three years to ensure packaging and tracking systems are in place. Marketing authorisation holders will be required to place the safety features on the packaging of medicines which fall within the remit of the delegated regulation no later than February 9 2019, said the UK medicines regulator, the MHRA.

The European Medicines Agency has revised the templates for how product information should be set out to reflect the new rules. Any new marketing authorisations submitted from April 2016 will have to include information on the anti-tamper device on packaging. Changes to existing products will have three years to update their information and packaging.

Not all medicines will be required to carry the safety features, and the Directive includes a schedule of exempted items.

The Healthcare Distribution Association, representing pharmaceutical wholesalers, has welcomed the agreement that ‘risk-based’ wholesaler verification is included as part of the Falsified Medicines Directive legislation. “This issue was the biggest area of concern for HDA member companies, as alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients,” said the HDA.

“This threat has now been averted. ‘End-to-end verification’ has now been mandated throughout the EU, with the manufacturers of prescription medicines having to place ‘safety-features’ on all their medicines sold in the EU and those who dispense to patients will verify these ‘safety features’ before patients receive them.”

HDA Executive Director Martin Sawer added: “It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states. ‘Risk-based’ wholesaler verification was crucial in securing a credible and sustainable solution to secure the European medicines supply chain.”

The MHRA has also announced a change to the fee for registering as a business selling medicines online and for using the EU common logo to indicate the business is registered. From April 1, the registration fee will be £100, and the annual renewal fee will be £97. The annual charge for renewing registration will be payable on April 1 each year.

EUcommonLogo1

EU common logo: from The European Commission

Links:

EMA statement

MHRA statement

HDA UK comments

MHRA guidance on EY common logo

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