In advance of the launch of the new EudraVigilance System, on 22 November 2017, the EMA has published (on 5 July 2017) a 29 page Q&A, which is a summary of the broad ranging pre-launch questions submitted by stakeholders and the EMA’s answers. Answers have been kept succinct, with URL links to any further relevant guidance. The document is split into separate topics, including: Eudravigilance organisation and user registration; Reporting to National Competent Authorities in the EEA; and Technical Questions, with an index and a useful glossary of terms at the beginning of the guide. The Q&A will be updated regularly. The EMA recommends that the Q&A be treated as a first reference point for queries, before users contact the Agency’s service desk.
EMA Communications Plan
In addition, the EMA has published on 2 August 2017 a tabular communications plan, designed to identify when and how certain key information leading up to the launch should be provided to affected stakeholders, such as EU Regulators, MAHs, Sponsors, and Healthcare professionals (HPs). The plan also suggests the most appropriate “communications channel” for imparting each piece of information (e.g., email, newsletters, etc.), but notes that Member State are free to choose an alternative means of communication, should they so wish.