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Guidance: Guidance on pharmacovigilance procedures

Medicines Healthcare Products Regulatory Agency

October 14
12:32 2021

Details

See Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply to UK MAHs and the MHRA

Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars:

Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020:

Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020:

Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020.

Published 31 December 2020
Last updated 14 October 2021 +show all updates
  1. The guidance on pharmacovigilance procedures has been updated to provide clarity on submission and documentation requirements for various pharmacovigilance procedures including where the reliance procedure is used.

  2. New video entry - Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020

  3. Updated section 2 to include a list of reports received via the EMA from the 28 December to the 31 December

  4. First published.

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