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The Decentralised Procedure

Decentralised Procedure - Legal basis. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use (Text with EEA Relevance)Implementation date : 30 October 2005Addition of one procedure in the EU :Mutual Recognition Procedure (MRP)Decentralised (DCP)Centralised (CP).

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The Decentralised Procedure

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    1. The Decentralised Procedure Franois-Xavier Routhier EU Registration / CT Registration Head Novartis Pharma S.A.S. Paris, 12 Feb. 07

    2. Decentralised Procedure - Legal basis Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use (Text with EEA Relevance) Implementation date : 30 October 2005 Addition of one procedure in the EU : Mutual Recognition Procedure (MRP) Decentralised (DCP) Centralised (CP)

    3. DCP and MRP are alternatives to CP If CP use is not mandatory 1. Mutual Recognition Procedure (MRP) where the medicinal product has already a Marketing Autorisation in one member State at the time of application Decentralised Procedure (DCP) where the medicinal product has not received any Marketing Autorisation at the time of application

    4. DCP Steps

    5. DCP Assessment Step I 120 Days Day 0 RMS starts the procedure Day 70 RMS forwards the Preliminary Assessment Report (PAR),SPC , PL and labeling to the CMSs Until Day 100 CMSs send their comments to the RMS Until Day 105 Consultation between RMS and CMSs and applicant. If consensus not reached, RMS stop the clock and issue LoQ. Clock-off period Applicant sends the final response document to the RMS and CMSs within a recommended period of 3 months, which could be extended if justified Will submission of new data be allowed ? Day 106 - 120 RMS updates PAR to prepare Draft Assessment Report (DAR) draft SPC, draft labeling and draft PIL to CMSs. Day 120 RMS may close procedure if consensus reached. Closing point

    6. DCP Assessment Step II 90 days Day 120 (D0) If consensus not reached RMS sends the DAR, draft SPC, draft labeling and draft PIL to CMSs Day 145 (D25) CMSs sends final comments to RMS Day 150 (D30) RMS may close procedure if consensus reached Closing point No new data are allowed. Will new analysis be accepted ? Until D180 (D60) If consensus is not reached by day 150, discussion at Coordination Group of the outstanding issues Day 195 (D75) Possible Break-out session First discussion with all involved MS at Day 75. Isnt it late for a DCP ? Until D205 (D85) CMS Final position. Breakout Group of involved Member States reaches consensus on the matter Day 210 (D90) RMS may close procedure if consensus reached Closing point otherwise referral to the Co-ordination group

    7. Referral to CMD(h) 60 days Article 27(1) Directive 2004/27/EC : Co-ordination group CMD(h) Triggered if no consensus could be reached at Day 210 60-day process Fixed timelines : for a referral to CMD Referral only triggered in case of serious risk to public health in the following domains : E, S, Q, and explained in details by the disagreeing MS Referral failure will trigger a non suspensive automatic arbitration and switch from national agencies to EMEA/CHMP Positive MSs can issue a MA which will have to be varied according to the arbitration conclusions

    8. Referral to CMD(h) Characteristics A referral to the CMD(h) cannot be avoided by application withdrawal in one or more CMSs No automatic referral to CMD(h) if withdrawal before D120 If negative consensus is reached at D210 : no referral to the CMD(h) A referral to the CHMP cannot be advanced (skip the referral to CMD(h) ) No new studies but clarification is allowed during the referral to CMD(h) All MSs are participating but the RMS+CMSs only should decide by consensus What will be the role of these non CMSs in the discussion ?

    9. National Step 30 days After acknowledgement of the MS agreement to the AR, the SmPC , the labeling and the PIL : Within 5 days : The applicant sends high quality national translations to the MS MS shall adopt a decision within 30 days Will the MS able to stick to the timeline ? Will the MA decision be delayed for MS wanting to discuss the specificities of their own National Risk Management Plan ?

    10. When MRP, When DCP ? If a MA available in one MS : MRP If no MA available : DCP Up to the Applicant to choose : MRP is longer but issues are resolved during the national phase with one partner : important for NCEs in case of premature application MRP could allow the product launch in RMS immediately after first MA DCP is shorter but issues are discussed between 27 MSs adequate for generics application (or OTC drugs) adequate for Line Extension to an MRP

    11. In Summary An alternative to CP (if CP not mandatory) Time to approval shortened Multiple closing points introduced Opportunities for early cooperation between CMS provided Consensus building fostered Procedure of choice for Generics DCP success will depend on cooperation and communication between national agencies and the willingness to reach a consensus

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