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1 year ago

Work programme 2017

WC500221614

Medium-term objective

Medium-term objective MAWP initiative Activity description Timeframe Start End MRLs supports the safe use of veterinary medicines in regard to their impact on human health Commission in drafting implementing acts specified in Regulation 470/2009 2.1-7 Review the approach on genotoxic substances in the establishment of MRLs and authorisation of veterinary medicinal products 2.1-8 Finalise, in collaboration with ECHA and EC, the procedure for the establishment of MRLs of biocidal substances used in animal husbandry included in the 10-year review programme (long-used substances) 2015 2015 2017 2015 After 2017 Resources 2017 Financial resources (cost, thousand Euro) 4,840 Human resources (FTEs) 16 2.3. Post-authorisation activities Activity area Post-authorisation activities include all the activities performed by the Agency to maintain authorised medicines on the market and ensure that products on the EU market are kept up to date with scientific advances and are in line with the needs of authorisation holders. Activities covered in this area include the following: • Variations to marketing authorisations. These can be either minor (type IA or IB) or major (type II) changes to the product information and dossier with regard to the quality, safety and efficacy of the authorised product. • Applications for extensions of marketing authorisation. These include fundamental changes to the veterinary medicinal product, such as changes to the active substance, changes to the strength or pharmaceutical form, or a change or addition of a food-producing species to the authorisation. • Maintenance activities. These include follow-up on certain obligations that marketingauthorisation holders need to fulfil following the granting of a marketing authorisation. These include reassessment and renewal of marketing authorisations, as well as marketing-authorisation transfers when the legal entity of the marketing-authorisation holder changes. Drivers No major changes are expected in the area of post-authorisation activities during the period covered by this plan. The internal procedures for variations for veterinary products will continue to be reviewed alongside other business processes, taking into account the best practice developed in the management of procedures for human medicines applications in the Agency. Work programme 2017 EMA/583016/2016 Page 70/123

Workload indicators Results Forecasts 2014 2015 2016 2017 Variations applications, of which: 340 373 410 355 Type I A variations 175 196 243 180 Type I B variations 118 116 126 130 Type II variations 47 61 41 45 Line extensions of marketing authorisations 6 3 3 5 Performance indicators Results Targets 2014 2015 2016 2017 Post-authorisation applications evaluated within the legal timeframes 100% 100% 100% 100% Additional objectives and activities In addition to delivering its regular post-authorisation activities for veterinary products, the Agency plans to undertake and progress the following activities: Medium-term objective MAWP initiative Activity description Timeframe Start End Ensure efficient delivery of post-authorisation procedures 2.2-8 Implement improvements identified in the review of post-authorisation procedures 2017 2018 Resources 2017 Financial resources (cost, thousand Euro) 5,384 Human resources (FTEs) 11 2.4. Arbitrations and referrals Activity area The Agency conducts referral and arbitration procedures. • Arbitration procedures are initiated for nationally authorised products because of disagreement between Member States (e.g. in granting a variation or a marketing authorisation), or when over the years Member States have adopted different decisions for some medicines and discrepancies need to be harmonised. • Referrals are initiated regarding centrally and nationally authorised products to obtain harmonisation within the Community of the conditions of authorisation for products already Work programme 2017 EMA/583016/2016 Page 71/123