SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 1 NOVEMBER 2005 approaching The mutual recognition procedures as from1 November 2005

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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)

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 3 Mutual recognition after 30 October 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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’

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 6 Realization DP (2) Comments are processed in timetable, accorded by HMA, published on 9 June nd version of the SOP, discussed during MRFG of September Final version October

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 7 Timetable Pre-procedural phase Validation phase Assessment step 1 (day 0-119) Assessment step 2 (day ) National implementation phase (30- day)

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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 User consultation - Possible discussion in CMD about e.g. legal status - Import in CTS

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 9 Dossier requirements with 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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)

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 12 Assessment step 1 (Day ) Day 0Start procedure in RMS and CMS Day 70RMS sends preliminary assessment report (PrAR) to CMSs and applicant Until day 100 CMSs send comments to RMS and applicant Day consultation RMS and CMS about questions, RMS sends questions to company

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 13 Assessment step 1 (Day ) 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 14 Assessment step 1 (Day ) Option 2: Consensus minor comments Day 105RMS stops the clock; minor comments to the company Day 106 company sends answers RMS restarts the clock Day RMS updates PrAR Day 120 RMS sends FAR,incl.SPC/PL/Labelling RMS closes the procedure 30 days for national implementation

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 15 Assessment step 1 (Day ) Option 3 : No consensus Day 105RMS stops the clock; Request for Supplementary Information to the company Day 106 company sends answers RMS restarts the clock Day RMS formulates draft assessment report (DAR), including SPC, PL, label

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 16 Assessment step 1 (Day ) 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)

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 17 Assessment step 2 (Day ) Day 120 RMS sends draft assessment report to CMSs and applicant Day 145CMS sends comments to RMS and applicant

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 18 Assessment step 2 (Day ) Option 1: Consensus at day 145 Day 150RMS sends final assessment report (FAR), including SPC, PL, label RMS closes the procedure 30 days for national implementation

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 19 Assessment step 2 (Day ) Option 2: No consensus at day 145 Day Consultation RMS and CMSs Day 150RMS 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 20 Assessment step 2 (Until day 205) As from day 180 until day 205Break-out session If needed RMS gives oral report in CMD(if in same month) RMS always circulates minutes to CMD,CMSs and applicant

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 21 Assessment step 2 (Day 210) Option 1: Consensus Day 210RMS sends final assessment report (FAR), including SPC,PL,label RMS closes the procedure 30 days for national implementation

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 22 Assessment step 2 (Day 210) Option 2: No consensus Day 210Referral to CMD for 60-day procedure

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 23 CMD-referral (Day 0-60 ( )) 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 24 CMD-referral (Day 0-60 ( )) 1st CMD-meeting: around day 20 - clarification about the referral - information sufficient? - advice from ‘working groups’ of CHMP? - list of questions decided

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 25 CMD-referral (Day 0-60 ( )) 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 26 CMD-referral (day 0-60 ( )) Option 1: Consensus Day 60RMS 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 60referral to CHMP National implementation possible in MS with positive opinion

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 29 Referral (Q9) MRP started before 31 October 2005, and referral after 31 October 2005 National registration possible in member states with positive opinion

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 31 Leaflet Current MRP with day 90 after 31 October 2005: harmonisation of leaflet? Yes, unless its deviation is justified.

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 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.

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 33 THE END Thank you for your attention