Medicines and Healthcare products Regulatory Agency (MHRA) has now introduced a newly streamlined the procedure to speed up the process of moving medicines from prescription-only products to over-the-counter category.
The new procedure is underpinned by a new guideline on “How to change the legal classification of a medicine in the UK” published on the MHRA website. The new process outlined in the guideline could cut the time from application to decision by three months or more.
The guideline will come into effect immediately and has 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.
To streamline and shorten the reclassification process, the new guidance will help to minimise the need for formal commitment during the assessment process by increasing engagement with applicants before submission. It would help to encourage pre-application collaborative work with key stakeholders, stated the regulatory authority.
Further, the guidance would also reduce the types of applications which would require engagement with stakeholders during the application process. It would bring down the occasions on which expert advice would be sought. The process would make stakeholder engagement more focused and time limited.
Other improvements include a new presentational structure aimed at guiding applicants through the reclassification process from product development within companies to submission, assessment, approval and risk management activities.
The guidance 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.
New appendices present guidance on how to structure applications are consistent with the European guidelines which together with helpful information would help the pharma industry to avoid common pitfalls and frequently asked questions and answers, stated Jeremy Mean, Group Manager of Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency.
“The UK has long been recognized 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,” added the MHRA Group Manager.