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Brexit conceptual Map after Uk separation from Europe.

Uncertainty over the UK’s continued access to EU medicines databases after the Brexit transition period ends has resulted in all drug companies being asked to update their pharmacovigilance details in the UK’s licensing database after 1 January 2021 via variation procedures.

Specifically, all holders of UK marketing authorizations (MAs) – whether grandfathered from the EU system or existing national licences – will have to provide the Medicines and Healthcare products Regulatory Agency with an updated summary of pharmacovigilance systems (SPS) by filing a Type 1A variation application. The submissions should cover all UK product licences that sit under a unique pharmacovigilance system.

Companies will get an 18-month window - from 1 January 2021 until 30 June 2022 - to update the SPS details in their licences, unless they make changes to their UK qualified person for pharmacovigilance (QPPV), in which case these details must be submitted to the agency within two weeks, the MHRA’s Kiernan Trevett said at an industry conference this month.

The MHRA will have access to QPPV details listed in the so-called EU Article 57 database as of 31 December 2020, “but if that person subsequently changes, you will need to tell us because we won't have ongoing access to the Article 57 database,” said Trevett, who is an expert pharmacovigilance inspector at the MHRA.  (Also see "UK Offers Pragmatic Approach To Safety Reporting From Jan 2021" - Pink Sheet, 7 Sep, 2020.)

“Unfortunately, we have no alternative at this time” other than asking companies to submit “variations for every [product] licence in order to update their summary pharmacovigilance systems,” Trevett said at the Drug Information Association’s Global Forum for Qualified Persons for Pharmacovigilance (QPPV), which took place on 6-8 October. 

The EU Article 57 database – also known as the eXtended EudraVigilance Medicinal Product Dictionary – has been in operation for several years and companies have been updating their pharmacovigilance system details through a self-service portal.

This has resulted in the MHRA’s licensing database becoming “completely out of date” on pharmacovigilance system details and the agency is therefore asking companies to “provide us this information directly” via variation applications, she explained.

As there are about 18,000 UK national licences, this is a huge task for both industry and the MHRA that must be completed by 30 June 2022. To ensure a structured approach, Trevett explained that the agency has “anchored” the SPS-related variations to changes to the QPPV, as follows:

    • For existing UK national licenses: If, on 1 January 2021, the company’s UK QPPV is the same person as stated the Article 57 database, no action will be needed straightaway. If, however, after the January date, the UK QPPV’s role is assigned to a different person or the UK QPPV moves to another location, “you will need to notify us within two weeks” by submitting a Type 1A variation “for all of the UK MAs that are under the system for which that QPPV is responsible,” Trevett explained. If no changes are anticipated to the UK QPPV, companies will still have to submit a variation application by 30 June 2022 “so that we know which [product] licences are under which systems and that's the only way we can get that information,” she added.
    • For centrally authorized products converted into UK MAs: Companies will have one year (ie, until 31 December 2021) to submit the baseline initiating sequence data and related information in the electronic common technical document (eCTD) format. If, at the point of submitting the initiating sequence data, the UK QPPV is different to the person listed in the Article 57 database on 31 December 2020, companies should simultaneously submit a Type1A variation. The MHRA willl process “the initiating sequence [data] first and then vary it immediately based on the simultaneous variation that you've submitted,” Trevett said. If there are no immediate changes to the QPPV, companies can wait for their products to become “true national MAs,” and submit the variations within the ultimate deadline of June 2022.
    • For all new UK MAs: Companies should include in their MA application a summary of their pharmacovigilance system, which should contain, among other things, proof that the company has at its disposal an appropriately qualified QPPV who resides and operates in the EU or the UK, details of the UK location from where the PSMF can be accessed electronically, and the UK PSMF number.
    • For products in respect of Northern Ireland: In addition to notifying the QPPV and PSMF details to the MHRA, companies must also continue to submit this information to the Article 57 database. This is because Northern Ireland will remain subject to EU medicines regulations following the end of the transition period.

Bespoke Solutions

Trevett urged companies to plan carefully how they intend to submit the SPS-related variations to the MHRA.

Some companies may “only have 10 MAs and it might not be such a big deal,” but there are companies with “2,000 UK MAs and it’s going to be a very different picture for them,” she said. “They'll need to engage with the MHRA” to “manage their [submission] strategy.”

The MHRA recommends that companies should submit SPS updates as single changes and in collections of no more than 25 product licences. While companies are being urged not to submit “more than two collections in a single package or within a single week without prior notification,” the agency is open to discussing a “bespoke submission strategy” with companies that have vast portfolios, Trevett said at an MHRA webinar on 22 October.

Industry Response

As the MHRA produces more guidance on post-transition arrangements, companies face significant changes in how the complex environment for medicines regulations will operate from 2021, said Ali Hansford, head of regulatory strategy policy at the UK pharmaceutical industry association, the ABPI.

“It’s essential that patient safety continues to be protected from 2021 which is why the MHRA must continue to work closely with companies on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation,” Hansford said.

The ABPI’s preferred position to avoid disruption in the long term “is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

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