The UK PSMF – What Will It Look Like?

How will the Pharmacovigilance System Master File (PSMF) be impacted by the UK’s departure from the EU?  What actions will companies with a UK Marketing Authorisation Holder (MAH)  need to take in the event of a no-deal Brexit? In this short article from our Pharmacovigilance Manager, Natasha Daly, we consider the questions and give advice on what you need to consider and what you need to do, if you are impacted. 


It is apparent that the MHRA will follow a similar approach to the EMA with respect to the management of PV activities, meaning that the following legal obligations will apply to a UK based MAH in a no-deal scenario:

  • Operation of a pharmacovigilance system
  • Appoint a QPPV that resides and operates in the UK
  • Maintain a PSMF (located in the UK)

What will the “UK PSMF” Look Like?

Firstly, the format and content of the UK PSMF are equivalent to that of the EU PSMF, so that’s helpful! Most MAHs are already familiar with the requirements of the EU PSMF and they follow the guidance outlined in GVP Module II. However, one should also be aware of the minimum requirements for the content and maintenance of the “UK PSMF” as laid out in HMR Schedule 12A.

Question: Do you have more than one PV system?

If so, the UK PSMF must describe the global PV operations and reflect the global availability of safety information for UK authorized products however, the annex content should be specific to UK authorized products.

Furthermore, all UK PSMFs must be registered with the MHRA and a unique PSMF number requested for each pharmacovigilance system for UK authorized products. Where the pharmacovigilance system is shared by several MAHs, a single request for a UK PSMF number should be submitted to the MHRA.

If you would like to speak to us about issues surrounding the above or seek our advice then call us on 00353 52 61 76706, e-mail us at: or complete the webform below and we will get back to you.


About the Author
Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority. You can read more articles by Natasha Daly clicking the link below.
Other articles by Natasha Daly