© safeguarding public health bromi variations ·launch meeting the cumberland hotel, london anne...
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Safeguarding public health
BROMI Variations · Launch Meeting
The Cumberland Hotel, London
Anne Ambrose 8th May 2008
Slide 2 May 2008
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BROMI - Variations
•Variations – High Volume work stream•Approx 22,000 variation applications received annually in UK. 50% Type IA 80% National
•Risk based approach to assessment.•Reduction in administrative burden.•Predictable approval times•Delivery of new ways of working.
Slide 3 May 2008
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Current Regulatory Framework
Regulation EC 1084/2003 – Mutual Recognition
Regulation EC 1085/2003 – Centralised Procedure
UK – Follows principles of Regulations EC1084/2003 and EU Best Practice Guidance
Slide 4 May 2008
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BROMI Concepts
Slide 5 May 2008
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Variations – Proposal for 3-tier modelfor certain categories of change – Based on MR procedures
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
Slide 6 May 2008
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BROMI - Variations
Choice of Categories for Self Certification or Expedited Processing:
• Review of National applications determined by MHRA.
• Categories with low number of invalidation/refusals.
• Changes that had become Type II with introduction of 1084/2003EC.
Slide 7 May 2008
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Variations – 3 tier model
Self Certification BROMI – ‘Tell and do’
- Approx 80% of current Type IA;- Approx 7000 per annum in UK
Type IA BROMI – 14 day scientific validation
Type IB BROMI – 30 day assessment procedure
Slide 8 May 2008
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BROMI -Variations
How would the 3-tier model help my company?
Change in name and address of MA Holder (same legal entity)•Current – Type IA with 14 Day validation procedure•BROMI – Self Certified change that can be implemented immediately
Slide 9 May 2008
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Minor Change in the Manufacture of the Active Ingredient
Current – Type IB 30-Day assessment procedureBROMI – Under certain conditions Type IA 14-Day validation
Replacement or addition of a manufacturer for a sterile product
Current – Type II 90-Day assessment procedureBROMI – Type IB 30-Day assessment procedure
Slide 10 May 2008
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BROMI Variations Pilot
Initial Phase 1st February – 31st July 2007
Limited Number of Companies (11 company groups)
Use of Sentinel Portal
Audit
Evaluation
Pilot extended to 31st January 2008
Slide 11 May 2008
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BROMI Variations Pilot – Participating Companies
GalpharmGSKLundbeckOrganonPlivaPfizerReckitt BenckiserRosemontSanofi- AventisTevaWockhardt
Slide 12 May 2008
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Procedures for Submitting BROMI Notifications
Self Certification:
Acknowledgment issued as MAH submits application through Sentinel Portal
Sentinel/Rama records updated in 14-Days and formal acknowledgment letter issued
Slide 13 May 2008
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BROMI Variations Applications Submitted
In total 609 BROMI Variations received during the 6 month pilot
BROMI Self Certification = 518BROMI Type IA = 74BROMI Type IB = 17
Slide 14 May 2008
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Applications Submitted
BROMI - Variations Pilot
38
69
44
86
107
119
0
20
40
60
80
100
120
140
Feb Mar Apr May Jun Jul
Month
Nu
mb
er Self Certification
Type IA BROMI
TypeIB BROMI
Totals
Slide 15 May 2008
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BROMI Self Certification
BROMI Self Certification by CategoryName and Address of PL Holder
Name of Active
Manufacturer of Active
Name & Address of Manufacturer
ATC Code
Secondary Packager
Batch Release and QC arrangements
Deletion of manufacturing sites
Batch size of Active
Spec of Active
New or updated CEP for active
New or updated TSE CEP
Excipient Specification
Test procedure for excipient
New CEP for excipient
New or updated TSE CEP for excipient
To comply with Ph Eur
Slide 16 May 2008
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Audit Outcome• Common Mistakes on applications
- Omission of Declaration Form - - Omission of updated PL and/or label- Inadequate QP Declarations- Multiple Ph Eur CEPs in a single notification
• Most common categories for error- Changes to Tablet or Capsule Markings- Change to Batch Release and QC Arrangements – QP Declarations- Manufacturer of active, – documentation- Change in company name/address
Slide 17 May 2008
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BROMI Variations Pilot
Company Questionnaire
Approval time – great advantage.
Admin burden – further reduction required.
Guidance and Procedure – further simplification required.
Pilot extended to 31st January 2008
Slide 18 May 2008
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Extension of Pilot
•Categories reviewed – Change #8. Batch release removed.
•Simplify guidance.
•Reduce Documentation Requirements.
•Improved audit
Slide 19 May 2008
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Applications Received Feb 07 – Jan 08
BROMI VARIATIONS PILOT Feb 07- Jan08
0
20
40
60
80
100
120
140
160
180
Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan
Month
Nu
mb
er
Pro
ce
ss
ed
Self Certification
Type IA BROMI
TypeIB BROMI
Totals
Approx 1,500 applications received in total
900 Self-Certified
Slide 20 May 2008
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BROMI – Variations
Final evaluation of pilot
Full Roll-out to MAHs.
National ApplicationsPortal Applications
Next StepsFurther amendments to Sentinel process and letters
issued
Slide 21 May 2008
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Next Steps
Revision of EU Variation Regulations
•Two categories of Type IA notification- Those requiring immediate notification- Those that can be included in an annual update
•Downgrading of variations that have received a scientific opinion
