Manufacturers of non-prescription medicines in the UK will be permitted to make changes to the labelling of their products, without submitting them to the regulatory authorities, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
The aim is to make regulations covering over-the-counter medicines ‘more proportionate and targeted’, according to the agency. Companies must commit to an internal certification procedure to make sure that any changes are within current guidelines.
UK Health Minister Andy Burnham made the announcement in tandem with publishing the first report of the Better Regulation of Over-the-Counter Medicines Initiative (BROMI) group, which aims to free up the market for OTC medicines by reducing the red tape governing them which was designed with prescription-only medicines in mind.
The move would take away some of the administrative burden on the MHA and free up time for other activities such as monitoring medicines safety
MHRA chief executive Professor Kent Woods said: "OTC medicines contain well-established ingredients whose risks and benefits are well known. It is therefore suitable to introduce new ways of regulating OTC products that are proportionate, targeted, accountable, consistent and transparent."
Companies will still need to submit changes to the MHRA, which will audit a sample of such filings. Any breaches will face a range of sanctions, from a requirement to submit changes for approval in future to publication by the Agency of contraventions and, in serious cases, the threat of a product's market authorization withdrawal.
In addition the MGRA, BROMI includes representatives from the Proprietary Association of Great Britain, the non-prescription trade body, the National Pharmacy Association and wider government.