As it is quite inevitable that the transition period for the Brexit is not going to extend, numerous Regulatory changes or updates are expected to emerge from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the same context, MHRA has recently issued a guidance on pharmacovigilance procedures and post transition requirements for Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master Files (PSMF) for the UK authorized products.

Pharmacovigilance (PV)

MHRA announces that the responsibility for pharmacovigilance retains across the UK from January 1, 2021, but it is different for products sold in Northern Ireland and Great Britain. That means that Northern Ireland will continue to follow EU legislation and requirements, whereas Great Britain will need to submit Pharmacovigilance data to MHRA, which includes the UK and non-UK individual case safety reports (ICSRs), risk management plans (RPMs) periodic safety update reports (PSURs), and post-authorization safety studies (PASS) protocols and final study reports. The Sponsors must also submit historical PV data only if there is a specific request for assessment purposes.

The Agency will continue to accept the EU versions of RMPs and PSURs for the time being, but it may request the inclusion of additional information in an Annex. Until the MHRA issues final submission requirements and UK reference dates for RMPs and PSURs, the EU reference date (EURD) list must be followed.

Also, the MHRA provided a guidance document on actions for submitting and receiving ICSRs, signal detection, PASS, PAMs and major safety reviews.

Qualified Person Responsible for Pharmacovigilance (QPPV)

This guidance applies to all Marketing Authorizations (MAs) covering the UK, Northern Ireland or Great Britain. It states that the QPPV is responsible for the establishment and maintenance of the pharmacovigilance system and hence all the Marketing Authorization Holders (MAHs) must have a QPPV residing and operating in the EU/UK permanently. 

For MAs covering the UK or Northern Ireland, the legal requirements for the qualification and responsibilities of the QPPV (described in Article 10 of the CIR(EU) No 520/2012) will remain unchanged whereas for Great Britain, they are described in paragraph 10 of HMR Schedule 12A that mirrors Article 10 of CIR.

No temporary exemption will be provided to have a QPPV to reside and operate in the EU/UK and responsible for the pharmacovigilance system for the UK authorized products. It applies from January 1, 2021.

Pharmacovigilance System Master Files (PSMF)

The guidance applies to all the UK MAs that covers the entire UK, Northern Ireland or Great Britain. All the MAHs must maintain PSMF for the UK authorized products and submit them to the MHRA upon request.

According to Article 7(1) of the CIR, for the MAs covering the UK and Northern Ireland, the PSMF must be located either at the site where QPPV operates or in the European Union where the main pharmacovigilance activities are performed. The PSMF for the UK, Northern Ireland and Great Britain must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to regulation 187 of the HMRs are accessible. It must be immediately available for inspection at the pronounced location in the UK.

For MAs covering the UK or Northern Ireland, legal requirements for the format and content of the PSMF that are outlined in Chapter I of CIR will remain unchanged whereas, for Great Britain, they are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR.

According to GVP Module II, MAHs can either establish more than one pharmacovigilance system or it can be shared by several MAHs. The PSMF must be an accurate representation of the global pharmacovigilance system and all the MAHs covering the UK authorized products must make sure that the system is in place. You can always opt for a trusted Regulatory expert for a hassle-free process.


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