1 year ago

Work programme 2017


Medium-term objective

Medium-term objective MAWP Activity description Timeframe initiative Start End medicines research and acceptance of 3Rs (replacement, reduction, development activities refinement) testing approaches 4.2-9 Contribute to development of internationally harmonised guidance by VICH on applying the 3Rs approach to batch testing of veterinary vaccines and other relevant areas Before 2015 2017 Effectively manage risks to the environment arising from the use of veterinary medicines 2.4-7 Develop a guideline on risk assessment of veterinary medicinal products in groundwater 2.4-8 Provide advice to the European Commission to assist the preparation of their strategy on managing pharmaceuticals in water 2.4-6 Develop a strategic approach to persistent bioaccumulative and toxic (PBT) substances within the authorisation procedure for veterinary medicinal products 2013 2018 2013 2018 2014 2017 Resources 2017 Financial resources (cost, thousand Euro) 1,922 Human resources (FTEs) 7 2.7. Projects To support the Agency's work and achievement of the set objectives, a number of programmes and projects specifically related to veterinary medicines will be undertaken. The table below details the main veterinary-specific projects, their timelines and deliverables that the Agency will pursue in 2017. The main veterinary-specific projects in 2017 will relate to the veterinary IT programme and implementation of veterinary legislation. The cross-Agency projects that relate to both human and veterinary medicines (e.g. SPOR, e-Submission including common repository) are described in the project section of the Horizontal activities’ chapter (section 3.6). Programme / Legal basis Start End Deliverables 2017 Project date date Veterinary IT programme EudraVigilance veterinary v3.0 • Regulation (EC) 726/2004, art.57(d) Veterinary Change Programme Veterinary business process • New veterinary legislation (under drafting) 2017 2018 • Report and outcome of requirements and options analysis • Development of initial business case for approval Q2 2016 2017 • Finalising implementation based on final business case to release capacity and enhance preparedness for implementation of new veterinary legislation Work programme 2017 EMA/583016/2016 Page 78/123

Programme / Project Legal basis Start date End date Deliverables 2017 Governance/pote ntial centralisation of functions • New veterinary legislation (under drafting) 2017 2020 • Development of initial business case for approval • Finalisation of design phase Work programme 2017 EMA/583016/2016 Page 79/123

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