BREXIT: Pharmacovigilance – Key changes

PharmaLexperts – taking a pragmatic approach to Brexit….

On 01 September 2020, MHRA laid out the future requirements for placing medicines on the UK market after the end of the Brexit transition period on 31 December 2020.  Our team, which includes SMEs from the UK and the EU, is here to work with you to map out the impact for your operations and offer cohesive, practical solutions to assist you with a smooth transition

Key Changes for Pharmacovigilance

• Submissions: Submission requirements for Individual Case Safety Reports (ICSRs), Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs) for products supplied in Northern Ireland will remain aligned with EU requirements while the rest of the UK will follow national procedures.
  • ICSRs will need to be submitted to the MHRA via their online Gateway and therefore access to this system will be required prior to 01 January 2021 in order to avoid delays in submissions.
• PSURs: The MHRA may at some point issue a new list of UK-specific reference dates for PSURs potentially resulting in the submission of PSURs at different times in the UK and the EU. In the meantime though the EURD dates should be followed and from 01 Jan 2021 PSURs should be submitted in parallel to UK and EU.
• Notification Obligations: There is an obligation from 01 January 2021 to notify the MHRA of emerging safety issues within 3 working days after establishing that a signal or a safety issue from any source meets the definition of an emerging safety issue including standalone signal notifications submitted by you to the EMAthat are relevant to your products as well as signals raised by the EMA. For products placed on the market in Northern Ireland signals should be additionally reported to the EMA.

We will follow up with additional details/clarifications as more information becomes available and, in the meantime, please feel free to contact us at brexitsupport@pharmalex.com.