|Date:||6 December 2012|
|Subject:||MHRA publishes medicines reclassification guidance|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
Following the announcement in the Chancellor’s Autumn Statement, the Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
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:
- 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 focussed 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 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:
“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."
Notes to Editor1. This new process follows a consultation launched in July.
MHRA consultation on new guideline on how to change the legal classification of a medicine in the UK
2. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
3. Guidance on how to change the legal classification of a medicine.
How to change the legal classification of a medicine