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Revision of Regulation 1107/2009 & Regulation 396/2005

Revision of Regulation 1107/2009 & Regulation 396/2005. Euros Jones March 2014 Euros.jones@ecpa.eu. Objectives. Proposal to amend Regulations 1107/2009 & 396/2005 ECPA is looking to: Highlight key areas of concern

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Revision of Regulation 1107/2009 & Regulation 396/2005

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  1. Revision of Regulation 1107/2009 & Regulation 396/2005 Euros Jones March 2014 Euros.jones@ecpa.eu

  2. 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

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

  4. Review clause dates… Regulation 1107/2009 - 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 396/2005 - Article 47 • By 5 April 2015, a report on the implementation of the residues Regulation and any appropriate proposals Regulation 1107/2009 - 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

  5. Improve the regulatory process:Key elements… 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

  6. Looking to improve the regulatory process • Looking at future changes • For both Reg.1107/2009and 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

  7. Improve the regulatory process:Phase 1 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

  8. Improve the regulatory process:Phase 1 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!)

  9. Improve the regulatory process:Phase 2 2015 review for 1107/2009 and396/2005 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’)

  10. 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 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!

  11. Improve the regulatory process:Phase 3 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…

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

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

  14. Thank you!

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