101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 145 We’re following the below principles in developing independent processes and systems for regulatory activities.  We would minimise impact on stakeholders, where possible. For example, we would continue to accept EU application forms and EU standards for submission, where possible. We would continue to accept the eCTD (electronic common technical document) for submission of regulatory documents relating to an MA.  We would avoid unnecessary complexity, for example by following existing processes.  We would have systems up and running for March 2019. They would then be developed further over time. Development of new systems We’ll provide communications and guidance on the new processes and systems ahead of March 2019, so that you are able to use them from day one. We’ll communicate as soon as possible and intend to do this later this year. We’ll need some of our stakeholders to help us test our systems before March 2019, and where, required, we’ll also provide training. If you need to change your own systems to work with our new portal(s), we plan to provide notice and guidance to help you do this later this year. If your organisation will continue to be an EU stakeholder UK organisations should be able to continue interacting with the EU regulatory network as pe r EMA guidance and EU guidance.