Revision of Regulation 1107/2009 & Regulation 396/2005

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Presentation transcript:

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 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

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

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

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

Looking to improve the regulatory process 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

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

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!)

Improve the regulatory process: Phase 2 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’)

More information on: Proposal to remove zonal concept 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! FOOTNOTES: The zonal system remains > ECPA is committed to improve its functioning Harmonisation remains the goal > with or without zonal The zonal system will not be removed in the short term!! We need to continue working to improve its functioning as much as possible

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…

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

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

Thank you!