BROMI Variations – An Industry Perspective Helen Darracott Director of Legal & Regulatory Affairs, PAGB Gill Peckham Head of Regulatory Affairs Johnson & Johnson BROMI Variations Training Meeting 8th May 2008

An Industry Perspective Background BROMI principles of self certification Implementation of BROMI into the Company Key benefits BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 Background BROMI is a more efficient method of managing minor changes MHRA time spent approving minor changes was costing Industry time and money Industry have the expertise and knowledge to self certify these types of changes Aim was to free up MHRA time to concentrate on the more complex and important work BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 In short …. The OTC industry was looking for a way to reduce regulatory burdens and increase speed to market BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 Models of regulation 3rd party approval Full assessment Self certification Administrative burden reduced BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 MHRA - A changing role Checker Enforcer BROMI Variations Training Meeting 8th May 2008

Impact for OTC manufacturers Costs Administrative costs reduced by a third (£8.1 million) Time Reduced timelines means opportunity costs can be realised (£100 million) BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 Other advantages Better planning Greater flexibility Encourages innovation and allows companies to be responsive to market needs For MHRA frees up resource to focus on more complex and important work BROMI Variations Training Meeting 8th May 2008

BROMI Principles for Self Certification Standard operating procedures Follow MHRA guidance on BROMI requirements Safeguards Audit and monitoring (Complaints procedure) Sanctions BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 So, How Does it Work? BROMI Variations Training Meeting 8th May 2008

Variations based on a 3-tier model Self Certification Scientific Validation (IA) 30 Day Assessment (IB) Type IA Type IB Type II Pilot for national variations started February 2007 BROMI Variations Training Meeting 8th May 2008 11

BROMI Variations So, what do I have to do to utilise the BROMI Scheme? BROMI Variations Training Meeting 8th May 2008

Company implementation – a new way of working? Senior management sign off for increased responsibilities Revised SOPs and working practices for labelling changes we defined who is responsible for confirming conditions are met for variations we defined how BROMI changes would be managed we prepared necessary submission templates Training across the business BROMI Variations Training Meeting 8th May 2008

Updating Company Procedures Follow BROMI principles Named individual responsible for ensuring compliance Maintenance of adequate records to show the submission and implementation of BROMI changes How to assess whether a change is BROMI and which category BROMI Variations Training Meeting 8th May 2008

Updating Company procedures Company tracking documents to show submission and ongoing status of a BROMI change How to allocate the correct variation, completion of variation forms and submission of appropriate documentation BROMI Variations Training Meeting 8th May 2008

Updating Company procedures How to manage the change? Implement immediately? Await acknowledgement letters? What triggers advice to other departments that they can implement? Event flow following approvals who to inform – Supply Chain, QP, Manufacturing, Medical etc how to track implementation BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 Implementation For all the changes that are self certified we needed to monitor and record the implementation date and this was arranged with the Supply Chain Team BROMI Variations Training Meeting 8th May 2008

One Company experience – some practical examples During 2007 J&J submitted about 160 variations of differing types About 100 of these were standard variations Since the pilot was introduced a further 60 have been submitted as various BROMI variations BROMI Variations Training Meeting 8th May 2008

Some practical examples - Variations BROMI Variations Training Meeting 8th May 2008

Some practical examples - Variations The types of changes include: Increase in shelf life TSE certificate of suitability updates CEP updates for active ingredients Amends to EP specifications Adding measuring device Removal / Change of ink on capsule shell BROMI Variations Training Meeting 8th May 2008

Some practical examples - Variations This year:- We have to change the name and address of the company On about 120 licences, Including the manufacturing address in about half the cases BROMI Variations Training Meeting 8th May 2008

Some practical examples - Variations Self Certification BROMI’s are really helping us to manage this project successfully:- Using Type 1A Self certification Prepared stock with new labelling (no risk!) Submitted self certification just prior to the stock going onto the market – giving a maximum implementation window Allowed maximum flexibility to plan around stock availability BROMI Variations Training Meeting 8th May 2008

Advantages of BROMI to J&J In 2007 we submitted 38% of applications to PIQ as BROMI 35% of variations as BROMI We expect these %’s to rise in 2008 as User Testing will be completed and therefore less standard PIQ submissions. Name Change project will dramatically increase BROMI submissions BROMI Variations Training Meeting 8th May 2008

Advantages of BROMI to J&J For J&J, BROMI has achieved:- cost savings time savings (internally and externally) increased ability for stock planning, The BROMI initiative has been one of the most helpful “outputs” from the MHRA in years and has greatly benefited J&J in practice BROMI Variations Training Meeting 8th May 2008

BROMI Variations Training Meeting 8th May 2008 “At last I can tell marketing how long something will take” “The best thing to come out of MHRA for a long time” “What’s not to like. It’s something that benefits us as well as them” “An incentive to innovate” “It’s made such a difference to the way we work” “Everyone wins; we get to market more quickly, people get the medicines they need & MHRA assessors can focus on the things they need to be involved with.” “BROMI has the potential to re-energise the OTC market” BROMI Variations Training Meeting 8th May 2008