Updated Guidance on Pharmacovigilance Procedures

The MHRA will retain responsibility for pharmacovigilance across the UK from 1 January 2021. There will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. For products placed on the market in Northern Ireland requirements will, in general, remain in line with EU requirements as indicated below.

We will require submission of all UK ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway. You can register on the MHRA-Gateway and/or ICSR Submissions portal to enable configuration for their systems prior to 1 January 2021.

MHRA will not require you to conduct signal detection against our own database. From 1 January 2021, this also includes standalone signal notifications submitted by you to the EMA. For products placed on the NI market, you are additionally required to report to the EMA those safety signals that are considered to meet the definition of an emerging safety issue.

You are obliged to notify the MHRA of emerging safety issues within three (3) working days after establishing that a signal or a safety issue from any source meets the definition of an emerging safety issue.

All PSURs with submission dates after 1 January 2021 should be submitted to the UK at the same time as submission to the EU. The content and format will remain the same as currently required in the EU. A fee of £890 will be payable for the assessment of PSURs for actives/ combinations currently listed on the EURD.

There will be a reduction to £445 for each PSUR where more than one PSUR is involved in the procedure. No further fee will be payable for the amendment of the product information as a result of the UK assessment.

For PASS where the study is a condition of the UK MA, prior to the start of the study the draft protocol should be submitted to the MHRA. Where the MA extends to Northern Ireland or is a Northern Ireland only MA the draft study protocol should also be submitted to the Pharmacovigilance Risk Assessment Committee. The final study report should be submitted within twelve (12) months of the end of data collection.

The reduced fee also applies where the MA has been granted via the unfettered access route. Both protocols and final study reports should be submitted to us using either the Type II complex variation route.

From 1 January 2021, UK products will continue to be part of Union referral procedures in respect of Northern Ireland. The scientific opinion and Commission Decisions will include UK products in respect of Northern Ireland.

MHRA may conduct a major safety review to review the available data and consider what regulatory action may be needed. Where you hold a MA for an affected product, you will be notified of the start of and reasons for the review. The outcome of the review will be published.

Post-authorisation obligations, including specific obligations, Annex II conditions, additional pharmacovigilance activities in the RMP (MEA), legally binding measures (LEG) or recommendations, in place on 1 January 2021 will remain in place. For converted EU MAs we recommend that you use the current application forms for PAMs and submit the information to us as a post-authorisation commitment.

From 1 January 2021 if you hold an MA which applies in Northern Ireland you should continue to monitor the EMA website. Where the UK has additional requirements, we will publish this on our own website shortly after the EU decision is published.

You should submit to the MHRA reports of all serious suspected adverse reactions that occur in the UK and other countries. You should submit copies of the Periodic Safety Update Reports (PSURs) to the MHRA portal. All other pharmacovigilance data submitted to the EU, including RMPs, PASS protocols and final study reports etc. should also be submitted to the MHRA.

Source: MHRA guideline on Updated guidance on pharmacovigilance procedures