MHRA
From 1
January 2021, for medicines authorized in Great Britain, Marketing
Authorization Holder (MAH) holders must maintain PSMF that described the
pharmacovigilance system for UK authorized products.
- The PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorized products.
- MAH need to make sure that every pharmacovigilance system covering UK authorized products has been assigned a unique PSMF number by the MHRA.
- A UK PSMF number can be requested via the MHRA Submissions Portal from 1 January 2021.
- A UK PSMF
number can be requested via the MHRASubmissions Portal from 1 January 2021.
- Single request for UK PSMF number should be submitted to MHRA, where the pharmacovigilance system is shared by several MAHs.
- For MAs that are specific to Great Britain: PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.
For MAs that are specific to Great Britain, legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR.
- For MAs that cover the whole of the UK or are specific to
Northern Ireland: the
PSMF must be located either at the site in the European Union, where the main
pharmacovigilance activities are performed or at the site where the QPPV
operates, in accordance with Article 7(1) of the CIR. The PSMF must be
accessible electronically at the same point in the UK from which the reports of
suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.
For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the format and content of the PSMF that are outlined in Chapter I of CIR will remain unchanged.
As the legal requirements concerning PSMF format and content are identical for MAs that cover the whole of the UK and Northern Ireland, and those that are specific to Great Britain, a single PSMF can be used for all UK authorized products.
Source💬: MHRA- www.gov.uk