Better Regulation of Medicines

The MHRA is committed to developing regulation which is accountable, proportionate, targeted, consistent and transparent. In order to meet these five principles, for the last year the Agency has been considering how regulation of medicines can be adapted. To take this important initiative forward, the Better Regulation of Medicines Initiative (BROMI) led by the MHRA, has brought together a broad ranging strategy group, which includes representatives from the Proprietary Association of Great Britain (PAGB), the non-proprietary sector, the National Pharmacy Association (NPA), the Department of Health, and the Cabinet Office.

Better Regulation is an important Government agenda, backed by the Prime Minister and Chancellor of the Exchequer, aimed at minimising bureaucracy for businesses and front-line staff in the public sector and delivering better public services. As part of this initiative, and in response to the Better Regulation Task Force report `Regulation - Less is More’ March 2005 (external link), all Government Departments have drawn up Simplification Plans. One aspect of the Department of Health’s Simplification Plan (which can be viewed at on the Department of Health website) is the work of BROMI (Better Regulation of Medicines Initiative).

The first report of BROMI was published in May 2006:
› Better Regulation of Over-the-counter Medicines Initiative: First report and recommendations (108Kb)

On 11 December 2006, BROMI published its second report:
› Better Regulation of Over-the-counter Medicines Initiative: Second report and recommendations (114Kb)

This report outlines further progress since the first report and developments include:

  • Wider roll out of the product information self-certification scheme to the Prescription Only Medicines (POM) sector.
  • Work on the development of a Code of Practice on pack re-design outlining a self-certification model for non-statutory packaging information.
  • Initiation of a review of the medicines statutory label warnings.
  • Progress on the second work stream in relation to variations, copy licences and change of ownership applications.
  • Identification of a third work stream in relation to pharmacovigilance requirements.

On 8 May 2008, BROMI published its third report:
› Better Regulation of Over-the-counter Medicines Initiative: Third report and recommendations (133Kb)

This report outlines further progress since the second report and developments include:

  • Self-certification scheme for certain minor changes to labelling and patient information leaflets rolled out to the prescription only (POM) sector from 1 November 2006 and the quality audit system has moved from 100% to 10%.
  • A self-certification scheme for certain Type IA national variations and an expedited process for certain Type IB and Type II variations went live on 1 April 2008.
  • A pilot for third party pre-approval of pack design changes to non-statutory information started in January 2007 and closed in January 2008. The Industry Trade Association, the PAGB is exploring the scope for enabling those other than existing PAGB members to use the scheme in order to gather more experience before it is signed off as a mainstream process.
  • A third party model for literature searching is under investigation.
  • A pilot is underway to assess the feasibility of MA holders working together to produce a common PSUR for the same active substance through a work sharing scheme.
  • A streamlined process for processing applications for copy licences under Article 10c of Directive 2001/83/EC (as amended) went live on 1 February 2007 and is being monitored.
  • A mechanism has been implemented to allow roll over of pending variations from the old to the new licence following a change of ownership application. This also includes the roll over of Periodic Safety Update Reports (PSURs) and renewals.
  • Key changes have been introduced in relation to Anonymised Single Patient Reports (ASPRs). ASPRs are now only provided based solely on the Volume 9A Pharmacovigilance Guideline definition of seriousness, and the MHRA no longer provides ASPRs to the MA holder who expedited the report.
  • A programme of work for streamlining renewals is under way.

BROMI Variations - Joint MHRA/Industry Training Day - 8 May 2008
The presentations from the above event are now available:

Additional guidance:

National informed consent ('simple abridged', Article 10c) applications
The process for approval of national marketing authorisation applications submitted under Article 10c of the Directive (‘simple abridged applications’) has been reviewed within BROMI.  Further information is available in the section below:
› National informed consent ('simple abridged', Article 10c) applications

The following presentation was presented at the 2008 MHRA Annual Conference. It highlights the most common deficiency areas related to BROMI simple applications
› Better Regulation of Medicines Initiative (BROMI) simple applications (831Kb)

Variations processing
Proposals have been developed to move towards a self-certification model for certain Type IA variations and to follow an expedited process for certain Type IB and Type II variations. To support this new way of working criteria and conditions for national procedures have been developed. Further background and information can be found below:
› BROMI Dossier Requirements for Type IA and Type IB UK National Notifications - Version 2.1 (615Kb)
› BROMI Dossier Requirements for Type IA and Type IB UK National Notifications - Version 2.1 (1013Kb)

A pilot study was undertaken with a limited number of companies from 1 February 2007 to 31 January 2008 to trial the scheme. Once it is fully utilised it is estimated that 80% of national Type IA variations could be self-certified by the marketing authorisation (MA) holder. The scheme is now available to all MA holders and further information on submission of applications can be found below:
› Submission of BROMI Notifications – Key Points (41Kb)

The following letter was sent to marketing authorisation holders in April 2008, giving an update on the progress made in relation to the voluntary BROMI variations scheme, and reminding them of their responsibilities should they choose to use the scheme:
› Letter to marketing authorisation holders (23 April 2008): Better Regulation of Medicines Initiative (BROMI) - Variations Scheme (39Kb)


MHRA key BROMI contacts

Better Regulation of Medicines Initiative (BROMI) organogram


Page last modified: 19 May 2008