SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 1 NOVEMBER 2005 approaching...

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT

1 NOVEMBER 2005 approaching

The mutual recognition procedures as from1 November 2005

2


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)

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



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



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



15



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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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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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



19



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



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



1st CMD-meeting: around day 20

- clarification about the referral

- information sufficient?

- advice from ‘working groups’ of CHMP?

- list of questions decided

25



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


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

SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 1 NOVEMBER 2005 approaching...

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