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THE HUMAN MEDICINES (CORONAVIRUS AND INFLUENZA) (AMENDMENT) REGULATIONS 2020

16 October 2020

Proposing MP
Bury St Edmunds
Type
Written Ministerial Statement
Department
Department of Health and Social Care

At a Glance

Issue Summary

The statement addresses the introduction of regulations to support the deployment of a COVID-19 vaccine and the expansion of the annual flu vaccination programme.

Action Requested

The Human Medicine (Coronavirus and Influenza) (Amendment) Regulations 2020 will come into force on November 3, 2020, with measures to ensure safe mass rollout of a COVID-19 vaccine and improve access to necessary vaccines. The regulations were informed by public consultation receiving over 188,000 responses.

Key Facts

  • Independent Commission on Human Medicines (CHM) advises on the safety, quality, and efficacy of any vaccine.
  • Marketing authorisation processes remain the preferred route for deploying any vaccine.
  • The Regulations come into force largely on November 3, 2020, with some provisions to be brought into effect immediately after being laid before Parliament.
  • The regulations bolster safeguards to product authorisation and improve access to vaccines ahead of winter.
  • Over 188,000 responses were received from a public consultation on the proposals.
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