The past week has seen numerous guidance documents published by both UK Scottish Governments. From review, MAP has identified the following items of interest.
The UK Government has recently published:
- Guidance on pharmacovigilance procedures in the event of a no deal Brexit
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day
In terms of pharmacovigilance, the Government states:
“From exit day, for medicines sold in the UK, MA Holders (MAHs) will be required to submit pharmacovigilance data including UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post-Authorisation Safety Studies (PASS) to the MHRA. These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support UK public health.”
The CAPs guidance sets out how the MHRA will handle centralised applications that are still pending on exit day, in the event of no deal.
According to the Government:
“The approach of the MHRA is to take into account any assessment that has already been reported on before exit day. The handling will be determined by the stage of the procedure on the application was at on that day…
“As the MHRA does not hold supporting data for applications made to the EMA. Applicants will need to submit an application and supporting dossier to the MHRA.”
Elsewhere, the Scottish Government has introduced new legislation to protect residents who have chosen to access cross-border healthcare in the European Economic Area (EEA) in the event of no deal.
According to Health Secretary Jeane Forman:
“In these circumstances we have no choice but to introduce these regulations, which will protect people who have arranged treatment overseas but have yet to receive it, or have yet to claim reimbursement. They will also allow Scottish residents to continue to access cross-border healthcare in the EEA, and will allow citizens from other EEA countries to access treatment here, as far as that can be achieved.
“We are doing everything we can go protect citizens’ rights and also to ensure that EEA nationals living in Scotland have full access to NHS healthcare without restriction.”
MAP will continue to monitor for further updates regarding Brexit. Further information can also be found through contacting firstname.lastname@example.org