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Workshop description In this workshop different approaches are presented and discussed together with aspects of an effective procedural organisation and legal aspects. The workshop also addresses the possible benefits for the environment, eventual reduction in administrative burden by data sharing and any impact the system may have on applicants, agencies, national competent authorities, the European Medicines Agency EMA and other stakeholders. The workshop is a follow-up of the one held in November in Brussels. During the ongoing review of the EU legislation the necessity to improve the environmental risk assessment ERA of VMPs with a special focus on so called legacy products has been identified. Many legacy VMPs entered the market before an environmental risk assessment was introduced into the VMP authorisation procedure by the relevant EC legislation. Therefore, substantial information on environmental effects is missing for such legacy VMPs or at least not available to all EU competent authorities.

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Factors health professionals should consider when advising those travelling to Zika virus affected areas. A small number of cases have also occurred through sexual transmission. The infection often occurs without symptoms but can also cause an illness similar to dengue or chikungunya which are also transmitted by Aedes mosquitoes. A comprehensive risk assessment should be undertaken for any traveller going to areas with ZIKV transmission. The following factors should be considered for each traveller, and will help health professionals to assess and communicate the potential risks associated with ZIKV infection, and allow the traveller to make as informed a decision as possible regarding their travel plans.

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