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Development and implementation of Guidance Documents – the role of the European Commission Karin Nienstedt - DG SANTE / E3 ECCA-ECPA Conference, 11-12.

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Presentation on theme: "Development and implementation of Guidance Documents – the role of the European Commission Karin Nienstedt - DG SANTE / E3 ECCA-ECPA Conference, 11-12."— Presentation transcript:

1 Development and implementation of Guidance Documents – the role of the European Commission Karin Nienstedt - DG SANTE / E3 ECCA-ECPA Conference, March 2015, Brussels

2 Outline - why guidance documents (GDs)? - what kinds of guidance documents - process (how?) - update on on-going work (COM-GDs)

3 Why guidance documents? - GDs are not legally binding, but… - GDs are important because they … organise our work and… harmonise our approaches, therefore … …avoid discussions on particular issues coming up again and again (efficiency!) …give clarity and predictability to all involved parties (risk assessors, risk managers, notifiers, stakeholders, …)

4 How to draft and agree a GD? Complex situations Many players: MS + EFSA + stakeholders Ressources needed (e.g. time)

5 GDs are published / referred to in… - Commission Communications 2013/C 95/01 and 2013/C 95/02 - (linked to Regulations (EU) No 283/2013 and 284/2013 on data requirements for AS and PPPs) - Commission GDs on SANTE's website: _active_substances/guidance_documents/active_su bstances_en.htm _active_substances/guidance_documents/active_su bstances_en.htm

6 Different kinds of GD 1.procedural guidance 2.technical guidance (… on risk assessment) 3.… on interpretation of legislation (decision making at risk manager level) or requested by legislation  … but also some "mixed" GD…

7 1 - Procedural GDs - aim to agree on a way of working (process) - examples: GDs on confirmatory information, … on comparative assessment, … on draft registration report (mutual recognition / Zonal authorisation) … on parallel trade … (meanwhile more than 25 GDs)

8 1 - Procedural GDs Proposal COM or MS Consultation of stakeholders Discussion at PAFF (MS, EFSA) Consultation of stakeholders Taking note at PAFF revision

9 2 - Technical guidance documents - mainly on risk assessment or related technical issues - aim to give clarity on how to do RA in a given regulatory context - different pre / post 2002 process (creation of EFSA) - recent examples: Bee GD Aquatic GD Exposure GD …

10 Mandate to EFSA (selftask or COM) Endorsement by PSN EFSA Scientific Opinion (PPR / SC) RM consultation (e.g. prot. goals) EFSA Guidance document PAFF discussion PAFF taking note 2 - Technical GDs (EFSA involvement) revision

11 Mandate to EFSA (selftask or COM) Endorsement by PSN EFSA Scientific Opinion (PPR / SC) RM consultation (e.g. prot. goals) EFSA Guidance document PAFF discussion PAFF taking note 2 - Technical GDs (EFSA involvement) revision Impact? Implementation date? stakeholders … still finding the optimal way… Impact?

12 3 - GD on interpretation of / requested by Legislation - process chaired by COM - recent examples: strategic GD on monitoring (Art. 7.3 Directive 2009/128/EC) Interpretation of "negligible exposure" (Annex II Regulation 1107/2009) Seed Treatments

13 3 - GD on interpretation of / requested by Legislation (new procedures (!)) GD adopted by COM (College) Inter Service Consultation (COM) Stakeholder consultation MS experts (WG + PAFF) Draft Guidance Document ?

14 Interpretation of / requested by Legislation – on-going work strategic GD on monitoring (Art. 7.3 Directive 2009/128/EC) Draft GD discussed with MS and within COM Stakeholder consultation soon Interpretation of "negligible exposure" (Annex II Regulation 1107/2009) Advanced draft developed at MS WG – difficult discussions because of different MS-positions Next steps: Stakeholder consultation + ISC

15 Conclusions - Guidance documents are efficient non- legislative tools which increase harmonisation. - Discussions are sometime not easy – but just the fact of having a discussion is helping to agree on a GD between the parties - drafting / agreeing on GD need resources from all parties

16 Thanks to all parties for the useful discussions so far and the commitment shown to agree on Guidance Documents!


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