MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates
Posted 08 April 2019 | By
As Friday’s no-deal Brexit deadline approaches, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday published additional guidance covering the process for applying for a Certificate of Pharmaceutical Product (CPP) in case the UK leaves the EU without a deal.
The guidance is part of a series of 41 MHRA guidances and publications on a possible no-deal scenario
that have been in the works since January.
As part of MHRA’s CPP request service, the agency notes that normal service takes 10 days, though an urgent two-day service is also available.
“If the UK leaves the EU without a deal, MHRA will be able to issue a CPP for a grandfathered centrally authorised product
(CAP), however the expedited service (2 days) will not be available for the first CPP request relating to a grandfathered CAP,” the guidance says.
A grandfathered CAP is a CAP marketing authorization automatically converted to a UK marketing authorization.
Mandatory baseline data required for a grandfathered CAP should be submitted at least two days prior to the CPP request, MHRA says. CPP applicants are requested to alert the MHRA Certificates team by email at firstname.lastname@example.org
when an application is the first CPP request for a grandfathered CAP.
“If the baseline data submission is incomplete for CPP purposes, MHRA will stop the regulatory clock and advise the applicant. The data submission will need to be corrected before processing of the CPP can continue,” MHRA says.