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Pharmacy welcomes streamlining of POMs reclassification

Practice Pharmacy leaders, including the RPS's Sid Dajani (pictured), have hailed a move by the MHRA to speed up the reclassification process for prescription-only medicines as a “positive step” for pharmacists.

Pharmacy leaders have hailed an MHRA move to speed up the reclassification of prescription-only medicines (POMs) as a "positive step" for pharmacists.

The MHRA's guidance – which could slash by three months the time taken to reclassify medicines from POMs to over-the-counter (OTC) medicines – will help the government's drive to keep patients out of hospital, said contractor and Royal Pharmaceutical Society English pharmacy board member Sid Dajani.

"If we're pushing the agenda of public health and self care, then it's only reasonable that we need more potent and stronger medicines in our armoury," Mr Dajani told C+D.

"It's only reasonable that we need more potent and stronger medicines in our armoury" Sid Dajani, RPS

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But there would need to be support for pharmacists and extra training to ensure they were confident about the differences between OTC medicines and POMs, he added.

The MHRA published its guidance on procedures for reclassification requirements last week, after chancellor George Osborne set out the plans in his autumn statement.

The MHRA's move was part of the government's ‘red tape challenge' to reduce the burden of regulation on businesses.

The guidance encourages companies to work with the MHRA before they submit their request to have a medicine re-categorised. It includes guidelines to help companies make a risk assessment of the medicine to justify why it should be sold over the counter and how to structure an application in line with European guidelines.

MHRA group manager of vigilance and risk management Jeremy Mean said the move would "speed and streamline the way medicines are made available safely, with benefits for the medicines users, the regulator and the industry".

Proprietary Association of Great Britain director of legal and regulatory affairs Helen Darracott said the guidelines would "give a new impetus" to the reclassification process.

However the Guild of Healthcare Pharmacists said it was unfortunate that their suggestion of a Pharmacy+ category had not been explored further, following its response to a consultation on the guidance earlier in the year.


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