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MHRA to ‘halve’ time taken for POMs to reach pharmacy status

The Government has announced reforms to halve the time it takes for a prescription-only medicine to reach pharmacy status from six months to three months in a move GPs said could create ‘significant risk’ for patients.

The announcement, made by chancellor George Osborne in his Autumn Statement, means that a new streamlined system will be rolled out by the Medicines and Healthcare products Regulatory Agency (MHRA) to move medicines from prescription-only to over-the-counter much more quickly.

The Government hopes its new drug reclassification strategy will halve the time it takes for a medicine to reach pharmacy status from six to three months.

It will do this through increasing engagement with applicants before submission and encouraging pre-application collaborative work, reducing the types of applications which would require discussion with stakeholders during the application process, minimising the occasions on which expert advice would be sought and making stakeholder engagement more focussed and time limited.

The Department of Health says it will give patients more choice to manage their own healthcare by providing faster access to medicines and free up GPs to see more patients.

A spokesman for the MHRA confirmed that the new system would come into effect immediately and had been developed by the MHRA in collaboration with the pharmaceutical industry as part of the Better Regulation of Medicines Initiative (BROMI) and its response to the Government’s Red Tape Challenge.

Jeremy Mean, MHRA’s medicine risk manager, said: ‘The UK has long been recognised for its leadership in increasing access to medicines by making prescription medicines available over the counter where it is safe to do so.

‘The new process launched today, and guidance that underpins it, will speed and streamline the way medicines are made available safely, with benefits for the medicines users, the regulator and the industry.’

Dr Bill Beeby, chair of the GPC’s clinical prescribing committee, said: ‘It does put some things at significant risk because it means that people will be able to treat symptoms with more powerful drugs and unfortunately that sometimes will result in harm.

‘If the GMC almost forbids doctors to treat themselves I find it very odd that the general public are being positively encouraged to do that without the diagnostic skills. This is not a protectionist viewpoint but a safety viewpoint.’

‘Although the process may end up being quicker, every case will still need to be looked at on its merits. I hope that the process will still be transparent and that both sides will be able to put forward their argument and it will not just be based on the opinion of the pharmaceutical companies.’


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