Regulatory Focus™ > News Articles > MHRA Proposal Would Save Industry £5M Annually in Fees

MHRA Proposal Would Save Industry £5M Annually in Fees

Posted 22 October 2015 | By Michael Mezher 

MHRA Proposal Would Save Industry £5M Annually in Fees

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to reduce many of the industry fees it collects by 10-15%, and it will introduce a new fee for online pharmacies to cover the cost of implementing the EU Falsified Medicines Directive.

Fee Reductions

Earlier this year the UK's Department of Health conducted its triennial review of MHRA. As part of the review, the Department of Health recommended MHRA revise its fees to better "align income and expenditure."

The agency says it will lower most fees for marketing authorization and variations by 10%. The agency is also planning to reduce fees for applications using the decentralized procedure where the UK is listed as the reference member state by 15%.

MHRA says that it is able to make this fee adjustment due to "efficiency savings," which include reducing its workforce and downsizing its headquarters in recent years.

In total, MHRA believes these fee reductions will save industry £5 million per year in 2016 and 2017.

Online Pharmacies

In its second proposal, MHRA is asking legislators to allow the agency to collect fees from online pharmacies to cover the costs of implementing the Falsified Medicines Directive.

In 2011, the European Parliament and Council adopted the Falsified Medicines Directive(Directive 2011/62/EU), which is intended to prevent counterfeit or unlicensed medicines from entering into legal supply chains.

One of the directive's provisions, which went into effect on 1 July 2015, requires online pharmacies to display a logo verifying their authenticity on any webpages related to online pharmaceutical sales to the public.

MHRA says it wants to charge online medicine sellers a fee of £100 to obtain their logo, with an annual service fee of £97.

MHRA


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