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MHRA streamlines POM-OTC reclassification rules

Aims to speed the process of switching drug status from prescription-only to over-the-counter

TabletsThe UK's medicines regulator has simplified its procedures for dealing with requests to reclassify medicines from prescription-only (POM) to over-the-counter (OTC) status.

The Medicines and Healthcare products Regulatory Agency (MHRA) said its new streamlined rules could shave up to three months off the time it normally takes to come to a decision - potentially halving the process.

Jeremy Mean, MHRA group manager of vigilance and risk management of medicines at the MHRA, 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, and the 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."

The change came as part of the Chancellor's Autumn Statement last week and is underpinned by new guidance, which was developed in collaboration with pharma as part of the Better Regulation of Medicines Initiative (BROMI).

The new guideline, How to change the legal classification of a medicine in the UK, will come into effect immediately.

To streamline and shorten the reclassification process, the new guidance will:

• Minimise the need for formal engagement during the assessment process by increasing engagement with applicants before submission and encourage pre-application collaborative work with key stakeholders

• Reduce the types of applications which would require engagement with stakeholders during the application process

• Minimise the occasions on which expert advice would be sought

• Make stakeholder engagement more focused and time limited

The guidance also includes a new section on benefit risk assessment to help applicants evaluate a candidate product prior to submission, to provide a rationale for their justification that the balance of benefits and risks are in favour of the product as a non-prescription medicine.

The UK trade body for OTC manufacturers the PAGB has welcomed the change. Its director of legal and regulatory affairs Helen Darracott said shortening the process and the introduction of the new benefit-risk model “will give a new impetus to this programme”.

10th December 2012

From: Sales



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