eCTD submission Regulatory

MHRA Released Post-transition guidance on licensing medicines

The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketi

ng authorizations to how to register new packaging information for medicines after the transition date.

The post-transition guidances include 12 documents explaining how various aspects of pharmaceutical and biological product licensing will work beginning 1 January 2021.

The guidances include:

“Our members will be reassured that Government has provided some critical information to help them continue preparations for the end of the transition,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI). “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the [National Health Service] NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland protocol and on other areas of regulation.”

MHRA says that all CAP marketing authorizations will automatically be converted to UK marketing authorizations, and that existing CAPs will remain valid in Northern Ireland. The shift will leave MHRA as the UK’s “stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which were taken or carried out at EU-level except for decisions on marketing authorisation made through the European procedures to market products in Northern Ireland.”

Marketing authorization holders may opt out of the conversion process by notifying MHRA, which must be done by 21 January 2021. MHRA also asks that marketing authorization holders submit “essential baseline data” for their converted EU marketing authorizations in electronic common technical document (eCTD) format within one year.

MHRA also explains how companies can renew marketing authorization post-transition, noting that the renewal date for converted EU marketing authorizations will stay the same and that renewals should still be submitted nine months before expiration.

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