Pharmacovigilance and QPPV: Post-transition guidance from MHRA
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.Pharmacovigilance
MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be different requirements for products sold in Great Britain (England, Scotland and Wales) and Northern Ireland. Products marketed in Northern Ireland will continue to follow EU legislation and requirements, while products marketed in Great Britain will need to follow a different set of procedures.
Beginning 1 January 2021, marketing authorization holders (MAHs) with products authorized in Great Britain will need to submit pharmacovigilance data to MHRA, including UK and non-UK individual case safety reports (ICSRs), periodic safety update reports (PSURs), risk management plans (RPMs) and post-authorization safety studies (PASS) protocols and final study reports. Drugmakers are encouraged to register for the new MHRA gateway or the ICSR submissions portal as soon as possible to submit ICSRs to MHRA.
MHRA notes that the EU good vigilance practice (GVP) modules “will remain in force,” though the agency is planning to issue guidance to explain any exceptions and modifications to the EU guidance.
Sponsors are advised that historical pharmacovigilance data will not need to be submitted unless it specifically requests such data for assessment purposes.
For the time being, MHRA says it will continue to accept the EU versions of RMPs and PSURs but says it may request additional information to be included in an annex. For PSURs, MHRA says it “may develop [its] own submission requirements and develop a list of UK reference dates, but until this happens the EU reference date (EURD) list should be followed.”
The guidance also explains how PASS will be handled post-transition, with specific advice on PASS protocols and results submitted after the transition date and ongoing issues related to PASS protocols and final study reports.
For safety referrals with ongoing procedures not completed by 1 January 2021, MHRA says it will complete the assessment and issue its own decision based on the information at hand, including any decision reached at the EU level prior to 1 January 2021.
MHRA also explains that after 1 January 2021, it may conduct its own major safety review of a medicine or class of medicines authorized in the UK and assess a fee ranging from £51,286- £76,213 depending on the scope of the review.
QPPV and PSMF guidance
In a separate guidance, MHRA explains the legal obligations for UK MAHs to have a QPPV based in the EU or UK and to maintain a PSMF that is electronically or physically accessible from the UK at the same site where reports of suspected adverse reactions may be accessed.
“For all UK [marketing authorizations] MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates in the EU or the UK, and is responsible for the establishment and maintenance of the pharmacovigilance system,” MHRA writes.
MRHA notes that the legal requirements laid out in Article 10 of Commission Implementing Regulation (EU) No 520/2012 remain unchanged for marketing authorizations in the UK or specific to Northern Ireland. The requirements for Great Britain-specific marketing authorizations are found in paragraph 10 of HMR Schedule 12A as added by the EU Exit Regulations 2019.
MHRA also says it will not allow any temporary exemptions from the requirement to have an EU- or UK-based QPPV and that the requirement will apply from 1 January 2021. However, MHRA is allowing a one-year exemption from the requirement to appoint a national contact person for pharmacovigilance based in the UK for companies that opt to establish a QPPV in the EU.