1 year ago

Work programme 2017


to address adverse

to address adverse events in food- following the publication of the revised producing species reflection paper 2.2-6 Ensure effective procedures are in 2016 2018 High - existing Incident Management Plan place to manage incidents and crises tested and updated in light of testing and relating to Veterinary Medicinal experience products - continuous monitoring and update in light of experience Quality of scientific output Provide high-quality and consistent scientific outputs of the EMA Ensure efficient operation of procedures within the Veterinary Medicines Division 2.2-7 Finalise the development and promote the uptake of the revised guideline, procedures and templates for CVMP assessment reports 2.2-8 Review operational procedures within the Veterinary Medicines Division 2016 2018 Medium - templates for assessors finalised - high-quality assessment reports received 2016 2017 High - improved performance metrics introduced, demonstrating an improvement in performance Objective 3: Improve the functioning of the single market for veterinary medicines within the EU Reflecting that the majority of veterinary products on the EU market are authorised at national level, the majority of specific activities under this strategic objective of the Network strategy are led by the EU medicines regulatory network, mainly through CMDh/CMDv. Several activities identified throughout this work programme will contribute to the effective functioning of the single market (e.g. Incident Management Plan, training, availability initiatives, development of advice that can support the work in Council and Parliament in relation to revision of the veterinary legislation) Work programme 2017 EMA/583016/2016 Page 26/123

Objective 4: Focus on key public and animal health priorities including antimicrobial resistance Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Contribute to minimising the risk to man and animals from 2.4-1 Engage with the EC and Member States to identify and, where possible, 2010 2019 Critical/ urgent - agreed list of priority and antimicrobial substances for referral to CVMP the use of antibiotics in prioritise the referral of antimicrobials veterinary medicine and other classes of products for which the conditions of use need to be both harmonised and aligned with the principles of prudent and responsible use, including in relation to environmental issues 2.4-2 Refine and continue data collection on 2010 Contin High - publish the outcome in the ESVAC the consumption of antimicrobials in veterinary medicine uous annual report 2.4-3 Develop and validate methodology to 2016 2017 High - methodology approved by the steering measure the use of antimicrobials per species in the major food producing group species 2.4-4 Provide advice to stakeholders on 2015 2018 High - draft reflection paper on prudent and responsible use of veterinary antimicrobials aminoglycosides published for consultation (in 2016) Antimicrobial resistance 2.4-5 Provide scientific advice to the EC on optimising the use of antimicrobials in veterinary medicine - draft reflection paper on extendedspectrum penicillins published for consultation (in 2017) 2015 2016 High - EMA-EFSA opinion on how to reduce the need for antimicrobials in foodproducing species published on EFSA and EMA website - plan for follow up actions to the Work programme 2017 EMA/583016/2016 Page 27/123

2017 Work Programme
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