MHRA publishes medicines reclassification guidance

Medicines regulatory news

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.

Press release: MHRA publishes medicines reclassification guidance

Guidance on how to change the legal classification of a medicine.

Fuente: MHRA

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON213230

[Posted 12/12/2012]