Module 12 2019

EU IG Comments and Next Steps

• +2.100 comments received – More than what EMA expected – need time for resolution – Revise the initial intention to publish an updated version by end June • Next Steps – Under discussion, looking at options 1. Publish v1.0 end June (as is) incl. comments made – limited interest

2. Resolve key comments (v1.1) and publish by September at the latest – incl. TOM approach? 3. Take time to resolve all comments incl. TOM and target publication by end 2019/early 2020 (v2.0) – Industry proposal to participate into resolution of comments and co-own EU IG – For discussion/decision at Task Force on 24 th May

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