Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure

• Date:
  Pátek, 20 Duben 2018, All day
• Místo konání:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency is holding this meeting to inform veterinary companies on Brexit regulatory preparedness for centrally authorised products and address any specific questions they may have further to the publication of European Commission and EMA questions and answers document and EMA procedural guidance. This event is targeting small and medium enterprises' needs (SMEs) and is also open to all companies and stakeholders developing veterinary medicinal products.

Documents

Agenda - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure

Report - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure

Reference Number: EMA/271499/2018

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Reference Number: EMA/478309/2017 Rev. 5

Presentation - Welcome and opening remarks (Christian Siebert)

Presentation - European Medicines Agency (EMA) update on Brexit preparedness activities and EMA working group on committees operational preparedness for veterinary medicines (Isaura Duarte, Tony Humphreys)

Presentation - Impact of Brexit on veterinary applications/marketing authorisations (Sandra Vanlievendael, Beyhan Mustafov, Andrei Spinei)

Presentation - Brexit: implications for companies (Rick Clayton)

Presentation - Brexit regulatory preparedness: small and medium-sized enterprises (SMEs) (Declan O'Rourke)

Presentation - 2018 European Medicines Agency-industry stakeholder interactions on Brexit related topics (Marie-Helene Pinheiro)

Multimedia