Guidance

Applying for a Certificate of Pharmaceutical Product in a no deal Brexit scenario

This guidance covers the process for applying for a Certificate of Pharmaceutical Product (CPP) if the UK leaves the EU without a deal.

Leaving the EU with a deal remains the government’s top priority. However a responsible government must plan for every eventuality, including a no deal Brexit scenario.

This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to offer our existing service for issuing a Certificate of Pharmaceutical Product (CPP). The normal service takes 10 days and a 2-day service is available for urgent requests.

CPPs for grandfathered centrally authorised products

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.

Mandatory baseline data required for a grandfathered CAP should be submitted at least 2 days prior to the CPP request. CPP applicants are requested to alert the MHRA Certificates team by email at exports@mhra.gov.uk 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.

Published 8 April 2019