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Revision of Regulation 1107/2009 & Regulation 396/2005 Euros Jones March 2014

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Presentation on theme: "Revision of Regulation 1107/2009 & Regulation 396/2005 Euros Jones March 2014"— Presentation transcript:

1 Revision of Regulation 1107/2009 & Regulation 396/2005 Euros Jones March 2014

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3 Objectives Proposal to amend Regulations 1107/2009 & 396/2005 ECPA is looking to: Highlight key areas of concern Ask the Commission to meet its legal obligations to report and make proposals to both pieces of legislation Start a discussion with authorities and stakeholders

4 ECPA’s intention in developing this paper is to start a discussion with stakeholders and policy makers! We expect the ECPA view to evolve…

5 Regulation 1107/ Article 82 By 14 December 2014, a report on the functioning of mutual recognition the division of the Community into three zones and the application of the criteria for the approval of active substances Regulation 396/ Article 47 By 5 April 2015, a report on the implementation of the residues Regulation and any appropriate proposals Regulation 1107/ Article 62(5) By 14 December 2016, a report on the effects of the Regulation on data protection of tests and studies involving vertebrate animals Review clause dates…

6 ECPA view: There is a need for one review of Regulation 1107/2009 and Regulation 396/2005 to improve efficiency and coordination ECPA proposes that:  A proposal to amend Article 43 is made in 2014  In 2014, an external review by consultants be initiated to provide input for a future review  A report and proposal to amend both pieces of legislation is put forward in 2015 Improve the regulatory process: Key elements…

7 Looking at future changes –For both Reg.1107/2009 and Reg.396/2005 Suggestions in 4 phases…: Phase 1: > Implement current framework > Amend Article 43 Phase 2: > 2015 review: 1107/2009 & 396/2005 Phase 3: > Data protection review Phase 4: > Long-term review Looking to improve the regulatory process

8 Implement current framework… Zonal  Removing national requirements (inc. Efficacy data needs)  Inter-zonal cooperation  Zonal helpdesk AS evaluation  Guidance document development  EFSA dialogue MRL evaluation  Improve application of Article 12  One lead EMS  Clear procedure for MRL review after AS approval Improve the regulatory process: Phase 1

9 Amend Article 43  Given the complexity of Article 43, there is a need change the legislation to make it workable  The aim must be to reduce unnecessary complexity!  The key necessary changes would be:  The 43(2) which requires a ‘full submission’ 3 months after active substance re-approval  The need for a full review after the approval of each active substance in a formulation Amending Article 43 would require a co-decision process with Parliament and Council  We believe that a technical amendment can be carried out more quickly (with a single reading!) Improve the regulatory process: Phase 1

10 2015 review for 1107/2009 and 396/2005 Zonal  Removal of zonal concept AS evaluation  Replace hazard based cut-off criteria by risk assessment  Replace candidates for substitution criteria by risk assessment  Unlimited approval period for ASs MRL evaluation  Improve MRL review process (after AS re-authorisation)  Central (on-line) evaluation system  Timelines for MRL evaluations  Remove scrutiny (or delegated act) procedure for MRL setting  Fast-track MRLs (e.g. default MRLs, minor uses)  (Include provisions on biocides and ‘Lisbon-ise’) Improve the regulatory process: Phase 2

11 Why is ECPA advocating removal of Zonal system?  The zonal system can only work with the removal of national requirements  Experience shows that most national requirements are not being removed  Zonal therefore becomes an extra layer when it was intended to provide simplification  Product authorisations are taking longer in many cases  If zonal system does not provide the efficiencies that were expected and promised, we should remove it! More information on: Proposal to remove zonal concept FOOTNOTES:  The zonal system remains > ECPA is committed to improve its functioning  Harmonisation remains the goal > with or without zonal FOOTNOTES:  The zonal system remains > ECPA is committed to improve its functioning  Harmonisation remains the goal > with or without zonal

12 Data protection review (1107/2009) AS evaluation  Data call-in system for AS review  Data sharing provisions  10 years data protection Similar to US system… Improve the regulatory process: Phase 3

13 Long-term review (1107/2009) AS evaluation  Single evaluation of ASs (with centralised coordination)  Evaluation of the benefits of uses/PPPs/ASs Improve the regulatory process: Phase 4

14 ECPA’s intention in developing this paper is to start a discussion…

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16 Thank you!

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