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Brexit

The Medicines and Healthcare products Regulatory Agency has issued guidance explaining how a pharmacovigilance system for UK authorized products would work from 1 January 2021, when the transition period after Brexit comes to an end.

As the MHRA has largely adopted the current EU pharmacovigilance rules – while introducing some UK-specific obligations – a senior industry expert believes the UK guideline represents a “pragmatic and simplified approach.”

The MHRA has allowed for some flexibility to make it easier for industry to simultaneously comply with UK and EU requirements relating to the appointment of a qualified person for pharmacovigilance (QPPV) and the maintenance of a pharmacovigilance system master file (PSMF), said Willemijn van der Spuij of Bristol Myers Squibb.

In the MHRA guideline, there is a “continued link with the EU” for both QPPV and PSMF requirements, “allowing companies to leverage some of the existing structures in place already,” said Van Der Spuij, who is executive director, Europe, of worldwide patient safety at BMS.

For example, similar to the EU system that requires the QPPV to reside and carry out tasks in a European Economic Area (EEA) member state, the MHRA will require that for all UK marketing authorizations (MAs), the company must have permanently and continuously at its disposal a QPPV who resides and operates in the EU or the UK.

The guideline, however, introduces some UK-specific requirements on which the industry may need further clarity. The MHRA states, for example, that if a company chooses to establish a QPPV who resides and operates in the EU, then it must additionally nominate a “national contact person” for pharmacovigilance who resides and operates in the UK and reports to the QPPV.

Nimisha Kotecha of IntuVigilance, a pharmacovigilance service provider, said it remained unclear whether the UK national contact person was equivalent to a local QPPV and would function alongside the EU QPPV.

While the MHRA’s guideline seems to suggest that the UK contact person has a similar remit to that of a local QPPV, the agency “may need to spell that out” to align with how industry understands pharmacovigilance requirements, Kotecha told the Pink Sheet. “I believe there may still be a bit more work to do in clearly defining the role of the UK National Person or QPPV, and Industry is likely to want discussions around these new requirements in the coming weeks and months.”

As per the MHRA guideline, while the requirement to have a QPPV for UK MAs will apply from 1 January 2021, a temporary exemption of 12 months will be allowed to give companies enough time to appoint a national contact person for pharmacovigilance. Further guidance on how companies can notify the MHRA about the details of their QPPV and the national contact person will be published in due course, it said.

PSMFs

From 1 January 2021, the MHRA will also require companies to maintain, and make available upon request, a PSMF that describes the pharmacovigilance system for UK authorized products. All PSMFs that cover UK authorized products should be registered with the MHRA and companies can request a unique UK PSMF number from the January date for each pharmacovigilance system that they are operating.

The MHRA is advising companies not to request the UK PSMF number unless they intend to notify a change in the details of their QPPV for UK authorized products from the baseline information held by the MHRA (ie, QPPV details that were registered in the eXtended EudraVigilance Medicinal Product Dictionary as of 31 December 2020).

Regarding the location of UK PSMFs, the MHRA is allowing some flexibility to accommodate EU rules. While the EU requires the PSMF to be located within the EEA, the MHRA states that the PSMF must be accessible electronically or physically from the UK at the same site where reports of suspected adverse reactions may be accessed.

The actual location of the UK PSMF will depend on the type of MA, the MHRA explains. For MAs that cover the whole of the UK or are specific to Northern Ireland, the PSMF can be located either at the site in the EU where the main pharmacovigilance activities are performed or at the site where the QPPV operates.

For MAs that are specific to Great Britain (ie, not including Northern Ireland), the PSMF must be accessible electronically at the same point in the UK where the reports of suspected adverse reactions are accessible. The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK. (Also see "How To Get A ‘Great Britain’ Drug Approval In 2021" - Pink Sheet, 2 Sep, 2020.)

As the legal requirements concerning PSMF format and content are identical for MAs that cover the whole of the UK and Northern Ireland, and those that are specific to Great Britain, a single PSMF can be used for all UK authorized products. “This is assuming that the pharmacovigilance system applied to all products is the same,” the MHRA said.

The MHRA’s pharmacovigilance guidance is part of several guidelines issued by the agency to explain regulatory arrangements that will come into force at the end of the UK’s Brexit transition period, on 1 January 2021.  (Also see "UK To Have Own Conditional Drug Approval Scheme in 2021" - Pink Sheet, 3 Sep, 2020.)  (Also see "UK Explains Approach To Renewing Converted EU Drug Approvals in 2021" - Pink Sheet, 4 Sep, 2020.) (Also see "Time Is Short To Prepare For New Post-Brexit UK Regulation" - Generics Bulletin, 4 Sep, 2020.)

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