Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new and streamlined procedure to speed up the process of moving medicines from prescription-only to over-the-counter (OTC) medicines.
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.
The procedure is underpinned by a new guideline on ‘How to change the legal classification of a medicine in the UK’ published by the regulatory authority. The process outlined in the guideline could cut the time from application to decision by three months or more.
In order to streamline and shorten the reclassification process, the new guidance would minimize 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.
Further it would also reduce the types of applications which would require engagement with stakeholders during the application process. Besides it will help to minimise the occasions on which expert advice would be sought and 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 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.
New appendices present guidance on how to structure applications to be consistent with the European guidelines, together with helpful information on how to avoid common pitfalls and frequently asked questions and answers.
Jeremy Mean, MHRA Group Manager of Vigilance and Risk Management of Medicines at the MHRA said that 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 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.