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BROMI Variations Training Meeting 8th May 2008
BROMI Variations – An Industry Perspective
Helen DarracottDirector of Legal & Regulatory Affairs, PAGB
Gill PeckhamHead 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
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
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
Models of regulation
3rd party approval
Full assessment
Self certificationAdministrative burden reduced
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
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
So, How Does it Work?
BROMI Variations Training Meeting 8th May 2008
Variations based on a 3-tier model
Self Certification
Self Certification
Scientific Validation (IA)
Scientific Validation (IA)
30 Day Assessment(IB)
30 Day Assessment(IB)
Type IAType IA Type IBType IB Type IIType II
Pilot for national variations started February 2007
BROMI Variations Training Meeting 8th May 2008
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
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
Regular62%
BROMI38%
BROMI
Regular
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
“The best thing to come out of MHRA for a long time”
“The best thing to come out of MHRA for a long time”
“BROMI has the potential to re-energise the OTC market”
“BROMI has the potential to re-energise the OTC market”
“An incentive
to innovate”“An incentive
to innovate”
“At last I can tell marketing how long something will take”
“At last I can tell marketing how long something will take”
“It’s made such a difference to the way we work”
“It’s made such a difference to the way we work”
“What’s not to like. It’s something that benefits us as well as them”
“What’s not to like. It’s something that benefits us as well as them”
“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.”
“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.”
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