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BROMI Variations · Launch Meeting The Cumberland Hotel, London

BROMI Variations · Launch Meeting The Cumberland Hotel, London . Anne Ambrose 8 th May 2008. 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.

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BROMI Variations · Launch Meeting The Cumberland Hotel, London

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  1. BROMI Variations · Launch Meeting The Cumberland Hotel, London Anne Ambrose 8th May 2008

  2. 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.

  3. 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

  4. BROMI Concepts

  5. Variations – Proposal for 3-tier modelfor certain categories of change – Based on MR procedures Scientific Validation (IA) Self Certification 30 Day Assessment (IB) Type IA Type II Type IB

  6. 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.

  7. 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

  8. 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

  9. Minor Change in the Manufacture of the Active Ingredient • Current – Type IB 30-Day assessment procedure • BROMI – Under certain conditions Type IA 14-Day validation • Replacement or addition of a manufacturer for a sterile product • Current – Type II 90-Day assessment procedure • BROMI – Type IB 30-Day assessment procedure

  10. 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

  11. BROMI Variations Pilot – Participating Companies • Galpharm • GSK • Lundbeck • Organon • Pliva • Pfizer • Reckitt Benckiser • Rosemont • Sanofi- Aventis • Teva • Wockhardt

  12. 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

  13. BROMI Variations Applications Submitted • In total 609 BROMI Variations received during the 6 month pilot • BROMI Self Certification = 518 • BROMI Type IA = 74 • BROMI Type IB = 17

  14. Applications Submitted

  15. BROMI Self Certification

  16. 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

  17. 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

  18. Extension of Pilot • Categories reviewed – Change #8. Batch release removed. • Simplify guidance. • Reduce Documentation Requirements. • Improved audit

  19. Applications Received Feb 07 – Jan 08 Approx 1,500 applications received in total 900 Self-Certified

  20. BROMI – Variations • Final evaluation of pilot • Full Roll-out to MAHs. • National Applications • Portal Applications • Next Steps • Further amendments to Sentinel process and letters issued

  21. 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

  22. Do you have any further suggestions? • BROMI@mhra.gsi.gov.uk

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