UK MHRA ISSUES SECOND REPORT ON OTC DRUG REGULATION

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published a second report on the Better Regulation of Over-the-Counter Medicines Initiative (BROMI). The report outlines further progress necessary to reduce unnecessary regulatory burdens, primarily in relation to OTC drugs. This initiative is one of the measures included in the Department of Health's Simplification Plan, which is part of the government's wider efforts to cut unnecessary burdens on business.

The first BROMI report, issued in May, has resulted in:Wider roll out of the product information self-certification scheme to the prescription drug sector; Progress on the development of a code of practice on packaging redesign outlining a self-certification model for non-statutory packaging information;Initiation of a review of the medicines statutory label warnings;Progress on a second work stream in relation to variations, copy licenses and change of ownership applications; and Identification of a third work stream in relation to pharmacovigilance requirements.

"This new way of working allows the MHRA to reduce time spent on carrying out administrative processes. Instead, more resources are available to concentrate on medicine safety, and labeling and packaging of newer complex medicines, thereby offering greater protection to the public," Kent Woods, CEO of the MHRA, said.

The report can be viewed at www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con2025468.pdf (http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con2025468.pdf).