1. 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

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

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

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

11. 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

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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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