MHRA: Post-transition guidance on licensing medicines
In its suite of post-transition guidances released Tuesday, 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transition period expires on 1 January 2021.The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing authorizations to how to register new packaging information for medicines after the transition date. (RELATED: MHRA posts suite of post-transition guidances, Regulatory Focus 2 September 2020).
“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.”
As such, ABPI is calling for more technical guidance from MHRA, especially with regard to the EU’s decentralized and mutual recognition procedures and how marketing authorization variations will be handled from 1 January 2021 on.
Licensing guidance
On 1 January 2021, 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.
For CAPs pending on 1 January 2021, MHRA will provide two different routes for companies to take to seek authorization in the UK depending on the stage of the procedure the application has reached. Company can apply for an “in flight assessment” for a Great Britain marketing authorization in parallel with the EU review or wait until the product has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to follow the new reliance route. The guidance provides a detailed table explaining how pending applications will be handled based what stage of review they are in on exit day.
MHRA provides a separate guidance explaining how it will handle marketing authorization applications referred under Article 29, which is triggered if consensus cannot be reached between member states on the outcome of an application reviewed under the mutual recognition or decentralized procedures.
A national scheme for conditional marketing authorizations (CMAs) is set to take effect on 1 January 2021 for Great Britain, mirroring the current EU system. MHRA’s existing system for marketing authorizations under exceptional circumstances will carry forward for Great Britain, though applications for Northern Ireland will need to go through EMA.
Biosimilars, advanced therapy medicinal products (ATMPs) and plasma master files (PMFs) are also addressed in a new guidance. MHRA explains that it will regulate biosimilars “according to the same principles that are applicable now,” and that Northern Ireland will follow EU legislation. After the transition period expires, MHRA explains that applications can only be made to reference products that have been authorized for at 8 years, including those that did not transition from an EU marketing authorization to a UK marketing authorization. “Data and market exclusivity period entitlements for reference medicinal products approved before the date of UK exit from the EU will continue to be applicable in the UK,” MHRA writes.
Similarly, MHRA says that ATMPs will be regulated nationally in Great Britain but will continue to be regulated according to the centrally authorized procedure in Northern Ireland. “Data, traceability, exemptions from licensing, packaging and post-authorisation requirements will remain unchanged from the current EU requirements and will be transposed into UK law,” MHRA writes, noting that the definitions of individuals classes of ATMPs will also remain unchanged.
MRHA says it will continue to recognize existing PMFs and associated inspections until further notice, but notes that it may transfer oversight of PMFs to a national system at a later date.
Two separate guidances explain what MHRA will consider as comparator products in bioequivalence/therapeutic equivalence studies and reference medicinal products post-transition; and two others address the conversion of parallel distribution notices to UK parallel import licenses and the handling of active substance master files and certificates of suitability.