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MHRA: Hard Brexit transfers for centrally authorised products

28 November 2018

Brexit

AUTHOR: Antony Appleyard



The MHRA have contacted licence holders for centrally authorised products (CAP) to provide further details about retaining access to the UK market in a Hard Brexit scenario. Guidance is being provided to existing CAP MAHs and those currently going through the CAP procedure.
It is anticipated that the guideline will be published online shortly, but in brief the Grandfathering Procedure being considered for implementation on the 29th March 2019 is as follows:

  • Existing CAP MAs transfer automatically into a UK MA
  • MAH can opt out of the process
  • MAH expected to submit a baseline eCTD sequence and other associated information to MHRA by 29th March 2020. Variations to the license would not be possible until this is complete, unless there are exceptional circumstances relating to public health
  • A new portal will be developed to enable these submissions
  • This process will have a facility for CAPs currently under assessment

The documents required for the baseline conversion include:

  • Cover letter stating that this is a CAP Grandfathering Procedure
  • A single initiating eCTD sequence (the latest authorised and approved position)
  • Completed electronic application form
  • Summary list of all historical regulatory activity from the date of grant of the original CAP until the data is submitted
  • Notification of whether the product referred to in the converted EU MA is on the UK market at the time the notification is given or, if not, whether the product has been on the UK market at any time after exit day and, if so, the date it was withdrawn from the market
  • Current EU procedure approved version of the Summary of Product Characteristics
  • Current EU procedure approved versions of packaging Labels and Leaflets

More details and links to guidance to follow

28 November 2018

Brexit

AUTHOR: Antony Appleyard