No Deal Brexit: MHRA Preparations for Pharmaceutical GMP

With the increasing likelihood of the UK crashing out of the EU pharmaceutical manufacturers and related stakeholders are a very confused lot. The MHRA, in anticipation of a no-deal scenario, has published several guidelines that will regulate medicines, medical devices, and clinical trials.

Brexit - pharmaceutical gmp

With the increasing likelihood of the UK crashing out of the EU pharmaceutical manufacturers and related stakeholders are a very confused lot regarding Pharmaceutical GMP. The MHRA, in anticipation of a no-deal scenario, has published several guidelines that will regulate medicines, medical devices, and clinical trials.

These publications and guidelines will be effective after October 31, 2019, in case the UK gets no deal on her way out of the EU. WE have made it easy for you to access any of the documents that you may need in this trying era.

Contents

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

This guideline covers the application for a Certificate of Pharmaceutical Product (CPP)  in the event of a no-deal Brexit.

  • The existing service for issuing a Certificate of Pharmaceutical Product (CPP) will continue under the MHRA.
  • Normal service – 10 days
  • Urgent requests – 2 days
  • For a grandfathered centrally authorized product (CAP), the expedited 2-day service will not be available for the first request

Required actions by CPP applicants

  • Submit mandatory baseline data for a grandfathered CAP at least 2 days before making the request
  • alert the MHRA team by email (exports@mhra.gov.uk) for the first CPP request

For incomplete baseline data for CPP, the MHRA will stop the clock then advice the applicant. Before continuing, the data submission will have to be corrected.

More Guidance Documents

 

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