Article 29(1) Referral

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2 Article 29(1) Referral DI(FH) Eva Pregernig, MSc AGES MEA, LCM, MRAT

3 Article 29(1) CMDh Referral Agenda What is an Article 29(1) CMDh Referral What can be done if PSRPH are raised? The CMDh Referral Procedure Keep in mind Questions

4 Article 29(1) CMDh Referral What is it? Follow up procedure if a CMS cannot approve the Assessment Report/Product Information on the grounds of potential serious risk to public health (PSRPH) Prerequisite: positive assessment by RMS Why: A Referral procedure should solve problems for the future and avoid repetition of discussion

5 Article 29(1) CMDh Referral The big issue Rarely somebody is prepared when a Referral is about to come Why to bother yourself with topics which are not on the table yet? Because Prevention is the best way to save money, time and your marketing authorisation There are things which can be done in advance!

6 What can be done if PSRPH are raised? DCP Before day 120: Try to resolve issues during the clock-stop Well prepared responses Submission of draft respones for assessment by RMS Discussions with RMS Last option: Withdrawal in CMS/s raising PSRPH

7 What can be done if PSRPH are raised? DCP After day 120: Prepare responses well Discuss issue with RMS and CMS (e.g.:teleconference) Consult with the RMS before taking action Be available and react quickly Last option: The application has to be withdrawn in RMS and all CMS to prevent a Referral

8 What can be done if PSRPH are raised? MRP/RUP Immediate discussion with RMS and CMS No clock- stop possible! The same applies for a DCP after day 120 The application as well as the existing marketing authorisations have to be withdrawn in RMS and all CMS to prevent a Referral

9 How is a Referral being triggered? Notification from disagreeing CMS to CMDh including detailed explanation for negative position in detail RMS initiates the Referral by sending AR, Product Information and a Notification to the CMDh Chair of CMDh and RMS decide on timetable

10 60 days Referral procedure Timelines What to do Day 0 Day 5 Day 8 Day 10 Draft LOQ is circulated among MSs MSs comment on draft LOQ Final LOQ is submitted to CMDh Applicant receives LOQ ~ Day 20 CMDh Meeting I Till day 24 Till day 25 Applicant gives Information if an oral explanation will be held Responses have to be submitted to CMDh members Applicant s Response Document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications

11 Responses during a Referral Procedure Follows the same rules as for DCP/MRP responses Responses have to be sent to CMD(h) members and CMDh secreteriat via and in addition a new sequence has to be sent to the CMSs and RMS The Annex of the Guideline on Responses states the exact subject to be used and what to be taken into account when using Eudralink

12 60 days Referral procedure Timelines What to do Day 0 Day 5 Day 8 Day 10 Draft LOQ is circulated among MSs MSs comment on draft LOQ Final LOQ is submitted to CMD(h) Applicant receives LOQ ~ Day 20 CMD(h) Meeting I Till day 24 Till day 25 Applicant gives Information if an oral explanation will be held Responses have to be submitted to CMDh members ~ Day 35 RMS ciruclates updated AR 7 days before Meeting II Comments from MSs ~ Day 50 CMDh Meeting II Oral explanation

13 CMDh Meeting II: Oral explanation Guidance on Oral Explanations to CMDh A written response to LOQ is always needed (day 25)! Within 2 weeks after receipt of LOQ, the applicant has to state if an oral explanation will be held at the CMDh meeting Presentation: Maximum 20 minutes Focus on responses to most relevant questions from the LOQ followed by a conclusive statement

14 CMDh Meeting II: Trend vote All MSs are involved in the discussion. A trend vote will be held among all MSs during CMDh Meeting II BUT Formal agreement among CMSs: Consensus has to be reached among CMSs of the DCP/MRP/RUP.

15 60 days Referral procedure Timelines What to do Day 0 Day 5 Day 8 Day 10 Draft LOQ is circulated among MSs MSs comment on draft LOQ Final LOQ is submitted to CMDh Applicant receives LOQ ~ Day 20 CMDh Meeting I Till day 24 Till day 25 Applicant gives Information if an oral explanation will be held Responses have to be submitted to CMDh members ~ Day 35 RMS ciruclates updated AR 7 days before Meeting II Comments from MSs ~ Day 50 CMDh Meeting II Oral explanation Day 55 Day 60 RMS circulates final proposal for agreement on the procedure Closure of the procedure or procedure referred to CHMP

16 End of Referral Procedure Positive outcome /Agreement among CMSs: Marketing authorisation issued within 30 days Negative outcome/no agreement among CMS: Referral according to Article 29(4) is triggered - Arbitration procedure

17 Keep in mind! Be available and react quickly Action is also needed in between actual dates of the timetable! Keep your colleagues up-to-date Information should be available at any time! Consult with the RMS before taking action! We as RMS are going to support you and guide you through! Each day counts the Referral is won or lost on day 60, not before!

18 Useful Information

19 Sources Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC Guidance on Oral Explanations to CMDh Applicant s Response Document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications CMDh Standard Operating Procedures - Disagreement in procedures Referral to CMDh Question and Answers CMDh Referrals

20 Dipl. Ing(FH) Eva Pregernig, MSc Regulatory Expert BASG - Bundesamt für Sicherheit im Gesundheitswesen Traisengasse Wien T +43 (0) eva.pregernig@ages.at