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Work programme 2017

WC500221614

In 2015, an updated

In 2015, an updated strategy for the next five years was developed and adopted for the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The Agency will continue to contribute actively to its implementation. A particular focus will be to foster the VICH Outreach programme, which aims to extend uptake of VICH guidelines to countries throughout the world with less developed regulatory systems. Workload indicators Results Forecasts 2014 2015 2016 2017 n/a Performance indicators Results Targets 2014 2015 2016 2017 n/a Additional objectives and activities Medium-term objective MAWP initiative Activity description Timeframe Start End Support increased availability of veterinary medicines 2.1-3 Set up a pilot project to evaluate how existing 2016 2017 data on antimicrobials can be extrapolated to promote retention on the market 2.1-4 Provide CVMP feedback on gap analysis from 2016 2020 the FishMed Plus coalition on availability of fish medicines 2.1-11 Finalise reflection paper on anthelmintic 2013 2017 resistance Develop a reflection paper on resistance in 2017 2019 ectoparasites Contribute to EU position for the revision of 2016 2020 VICH guidelines on anthlemintics (GL7, 12-16 and 19-21) 2.2-1 Provide necessary input to the European Commission during the co-decision process Before 2015 After 2018 for new veterinary legislation 2.2-2 Set up and develop a work plan for an ad hoc expert group to explore practical measures 2016 After 2018 that could form the basis for harmonisation of the SmPCs of veterinary medicinal products in the context of the revision of the veterinary medicines legislation 2.1-10 Contribute to the EMA/HMA task force on 2016 2020 Work programme 2017 EMA/583016/2016 Page 76/123

Medium-term objective MAWP initiative Activity description Timeframe Start End availability of authorised human and veterinary medicines 2.4-9 In cooperation with the European 2017 2019 Surveillance Strategy Group finalise revision of the Incident Management Plan for veterinary medicines and develop systems to facilitate management of shortages and ensure the adequate supply of essential veterinary medicines Promote uptake of harmonised standards at international level 4.2-6 Contribute to training events that raise awareness and enhance uptake of VICH Before 2015 After 2018 standards by non-VICH countries 4.2-5 Consider international scientific approaches for the establishment of MRLs for Before 2015 After 2018 harmonisation purposes Contribute to minimising the 2.4-4 Finalise the reflection paper on 2015 2018 risk to man and animals from the use of antibiotics in veterinary medicine aminoglycosides and publish for consultation the reflection paper on extended-spectrum penicillins 2.4-5 Work with the European Commission to 2015 2017 publish the outcome and follow up to the joint EMA-EFSA opinion on how to reduce the need for antimicrobials in food-producing species Prepare a second report in collaboration with 2016 2107 EFSA and ECDC on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals Prepare an opinion on indicators as regards 2016 2017 surveillance of antimicrobial resistance and antimicrobial consumption in humans and food-producing animals 2.4-2 Refine and continue data collection on the Before 2017 consumption of antimicrobials in veterinary medicine and publish the outcome in the ESVAC annual report 2015 2.4-3 Publish a harmonised methodology for 2016 2017 measurement of use of antimicrobials per species Publish reports on existing systems within the 2016 2017 EU for collection of data on use of antimicrobials in chickens and cattle Minimise the use of animals in 4.2-10 Improve the guidance available on regulatory 2014 2017 Work programme 2017 EMA/583016/2016 Page 77/123

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