spf sante publique, securite de la chaine alimentaire et environnement 1 november 2005 approaching...
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
1 NOVEMBER 2005 approaching
The mutual recognition procedures as from1 November 2005
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
Review 2001
Consequences for mutual recognition procedure
Introduction Decentralised ProcedureCreation Coordination group (CMD-(h))Patient leaflet and labelling part of the procedure More transparancy (public assessment reports)
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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’
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
Timetable
•Pre-procedural phase
•Validation phase
•Assessment step 1 (day 0-119)
•Assessment step 2 (day 120-210)
•National implementation phase (30-day)
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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)
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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 formulates draft assessment report (DAR), including SPC, PL, label
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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)
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
Assessment step 2 (Day 210)
Option 2: No consensus
Day 210 Referral to CMD for 60-day procedure
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
Referral (Q9)
MRP started before 31 October 2005, and referral after 31 October 2005
National registration possible in member states with positive opinion
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
Leaflet
Current MRP with day 90 after 31 October 2005:
harmonisation of leaflet?
Yes, unless its deviation is justified.
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
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.
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SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT
33 THE END
Thank you for your attention