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NOVEMBER 2005 approaching

NOVEMBER 2005 approaching. The mutual recognition procedures as from1 November 2005. Review 2001. Consequences for mutual recognition procedure Introduction Decentralised Procedure Creation Coordination group (CMD-(h)) Patient leaflet and labelling part of the procedure

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NOVEMBER 2005 approaching

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  1. NOVEMBER 2005 approaching The mutual recognition procedures as from1 November 2005

  2. Review 2001 • Consequences for mutual recognition procedure • Introduction Decentralised Procedure • Creation Coordination group (CMD-(h)) • Patient leaflet and labelling part of the procedure • More transparancy (public assessment reports)

  3. Mutual recognition after 30 October 2005 • 2 options • First marketing authorisation in 1 country, then start of mutual recognition procedure in other member states (MRP) • Decentralised procedure, submission of dossier in RMS and CMS at the same moment

  4. Mutual recognition after 30 October 2005 • Principles of Mutual recognition not changed; RMS formulates assessment reports and comments on SPC, PIL and labelling • Only reason for not adopting assessment from RMS is on the basis of ‘potential serious risk to public health’

  5. Realization DP (1) • 1st version of timetable and SOP determined by MRFG, published for consultation in March 2005 • Comments • - Validation period 28 days too long- too many comment rounds • - not competitive enough with CP • - no consolidated LoQ • - Commission: draft AR not in the clock-stop

  6. Realization DP (2) • Comments are processed in timetable, accorded by HMA, published on 9 June 2005 • 2nd version of the SOP, discussed during MRFG of 12-13 September • Final version October

  7. Timetable • Pre-procedural phase • Validation phase • Assessment step 1 (day 0-119) • Assessment step 2 (day 120-210) • National implementation phase (30-day)

  8. Pre-procedural phase(until day -14) • Consultation applicant and RMS • Possible issues • - Planning start • - Procedure number: NL/H/nnn/01/DC • - Pre-assessment of module 1.2 • - User consultation • - Possible discussion in CMD about e.g. legal status • - Import in CTS

  9. Dossier requirementswith regard to SPC, PL, label (1) UK-versions of SPC, PL, label Tested version of mock-up of PL Mock-up of label NB: in case of MRP UK-versions of SPC, PL, label RMS-version of mock-up of PL RMS-version of mock-up of label

  10. Dossier requirements with regard to SPC, PL, label • User consultation: • reporting of test • or • justification for tests during the clock-stop • or • justification for non-execution of the test • (e.g. reference to tested leaflet)

  11. Validation(day -14 until start) • Company submits dossier • Company distributes list with submission dates • RMS starts validation period in CTS • RMS informs company about validation problems • CMS informs RMS and company about validation problems (also in CTS) • Day -7: RMS starts automatic validation

  12. Assessment step 1 (Day 0 -105) Day 0 Start procedure in RMS and CMS Day 70 RMS sends preliminary assessment report (PrAR) to CMSs and applicant Until day 100 CMSs send comments to RMS and applicant Day 100-105 consultation RMS and CMS about questions, RMS sends questions to company

  13. Assessment step 1 (Day 105 -120) Option 1: consensus Day 105RMS updates Overview PrAR RMS sends final assessment report (FAR), including SPC, PL, label RMS closes the procedure 30 days for national implementation

  14. Assessment step 1 (Day 105 -119) Option 2: Consensus minor comments Day 105 RMS stops the clock; minor comments to the company Day 106 company sends answers RMS restarts the clock Day 106-119 RMS updates PrAR Day 120 RMS sends FAR,incl.SPC/PL/Labelling RMS closes the procedure 30 days for national implementation

  15. Assessment step 1 (Day 105 -119) Option 3 : No consensus Day 105 RMS stops the clock; Request for Supplementary Information to the company Day 106 company sends answers RMS restarts the clock Day 106-119 RMS formulatesdraft assessment report (DAR), including SPC, PL, label

  16. Assessment step 1 (Day 105 -119) • During the clock-stop: • Advice to company: draft answers to RMS • RMS responds to the draft answers • Company needs to accord date of submission of answers with the RMS (within 3 months after clock-stop)

  17. Assessment step 2 (Day 120 -145) Day 120 RMS sends draft assessment report to CMSs and applicant Day 145 CMS sends comments to RMS and applicant

  18. Assessment step 2 (Day 145 -150) Option 1: Consensus at day 145 Day 150 RMS sends final assessment report (FAR), including SPC, PL, label RMS closes the procedure 30 days for national implementation

  19. Assessment step 2 (Day 145 -180) Option 2: No consensus at day 145 Day 145-150 Consultation RMS and CMSs Day 150 RMS sends questions (List of Outstanding issues) to company By day 160 Applicants sends additional clarification incl. Proposol SPC/PL/Labelling By day 180 RMS formulates short report CMSs

  20. Assessment step 2 (Until day 205) As from day 180 until day 205 Break-out session If needed RMS gives oral report in CMD(if in same month) RMS always circulates minutes to CMD,CMSs and applicant

  21. Assessment step 2 (Day 210) Option 1: Consensus Day 210 RMS sends final assessment report (FAR), including SPC,PL,label RMS closes the procedure 30 days for national implementation

  22. Assessment step 2 (Day 210) Option 2: No consensus Day 210 Referral to CMD for 60-day procedure

  23. CMD-referral(Day 0-60 (210-270)) Objective: accordance between concerned member states about ‘potential serious health risks’ Discussion between all CMD members Coordination by CMD-secretariat Start of the procedure: < 30 days after day 210 End:at least 5-10 days after a CMD(h) meeting RMS refers the matter to the CMD(h) RMS leads the discussions Applicant can express preference for hearing or written reaction

  24. CMD-referral(Day 0-60 (210-270)) 1st CMD-meeting: around day 20 - clarification about the referral - information sufficient? - advice from ‘working groups’ of CHMP? - list of questions decided

  25. CMD-referral(Day 0-60 (210-270)) Day 35 Answers from the company (no new data) Day 45 RMS circulates updated AR to all CMD members Before 2nd CMD-meeting Written comments from member states 2nd CMD-meeting:around day 50 possibility for hearing experts from member states

  26. CMD-referral(day 0-60 (210-270)) Option 1: Consensus Day 60 RMS sends final assessment report (FAR), including SPC,PL,label RMS closes the procedure Positive opinion: 30 days for national implementation Option 2: No consensus Day 60 referral to CHMP National implementation possible in MS with positive opinion

  27. Forced arbitration? • Applicant can withdraw registration request during procedure, but in CMD discussion about ‘potential serious health risk’ should always take place in assessment step 2

  28. Referral to CMD (Q8) • Current MRP with day 90 after 31 October 2005 • New guideline comes into force: • Potential serious risk to public health -> CMD procedure and possibly CHMP • In case of withdrawal after 31 October 2005: always CMD procedure and possibly CHMP

  29. Referral (Q9) • MRP started before 31 October 2005, and referral after 31 October 2005 • National registration possible in member states with positive opinion

  30. Referral (Q10) • MRP/DP after 31 October 2005 • Withdrawal possible at any point of time during 210 days or 90 days respectively • However withdrawal during 90 days period of Assessment step II in DP or at any time during 90 days MR phase of MRP if based on psrph will be referred to CMD

  31. Leaflet Current MRP with day 90 after 31 October 2005: harmonisation of leaflet? Yes, unless its deviation is justified.

  32. Public Assessment-report (Q20) • MRP or DP, day 90 after 31 October 2005 • Always public assessment report, published on MRFG website (Product Index) • 60 days after closure of the procedure.

  33. THE END Thank you for your attention

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