Periodic Safety Update Reports (PSURs) for Medicinal Products in the UK

1. Introduction and Regulatory Context

Periodic Safety Update Reports (PSURs), also known as Periodic Benefit-Risk Evaluation Reports (PBRERs), are pharmacovigilance reports that summarise available safety data and review the benefit-risk balance of a medicinal product throughout its lifecycle. In the UK, PSURs remain part of post-authorisation pharmacovigilance reporting obligations for medicines authorised by the MHRA.
Source: Periodic Safety Update Reports (PSURs) for medicinal products (gov.uk)

As noted in MHRA pharmacovigilance procedures, marketing authorisation holders (MAHs) must submit PSURs to the MHRA or via relevant repositories, depending on the authorisation type and where the product is authorised (Great Britain vs Northern Ireland/EU). PSURs are used by regulators to detect changes in a product’s safety profile and to support ongoing benefit-risk evaluation.
Source: Guidance on pharmacovigilance procedures (gov.uk)

2. Legal and Reporting Framework

Under the Human Medicines Regulations 2012 (as amended), holders of UK marketing authorisations are legally required to submit periodic safety update reports at specified intervals, or when requested by the licensing authority. PSUR content must include summaries of data relevant to product benefits and risks, scientific evaluation of the benefit-risk balance, and exposure data such as sales and prescriptions.
Source: The Human Medicines Regulations 2012 — Periodic Safety Update Reports

Reports must be submitted electronically to the appropriate authority and may follow timelines established at the time of authorisation or according to a reference date list when no UK-specific dates are set.
Source: Pharmacovigilance following agreement of the Windsor Framework (gov.uk)

3. Scope and Content of PSURs

A PSUR must include the following:

• Summaries of safety data, including results from clinical trials and post-marketing experience.
• Scientific evaluation of the benefit-risk balance, taking all available data into account.
• Exposure data, such as the volume of sales and an estimate of the population exposed to the product.
  Source: The Human Medicines Regulations 2012 — Periodic Safety Update Reports

MAHs must not wait for the PSUR deadline to notify the MHRA of significant new safety or efficacy information; standalone safety signal notifications should be made promptly as they arise.
Source: Periodic Safety Update Reports (PSURs) for medicinal products (gov.uk)

4. Submission Requirements and Frequency

The frequency and submission route for PSURs depend on the type of marketing authorisation:

• UK-only authorised products (Category 1 licences) generally submit PSURs directly to the MHRA via the PSUR portal.
• Products authorised in both the UK and EU (Category 2) may use the EU PSUR repository with MHRA access; separate submission to the MHRA may be requested if access is not available.
  Source: Pharmacovigilance following agreement of the Windsor Framework (gov.uk)

Where UK-specific submission dates are set at authorisation, holders must comply with these timelines. In the absence of UK-specific dates, holders should follow the EU reference date list.
Source: Pharmacovigilance following agreement of the Windsor Framework (gov.uk)

5. Role in Pharmacovigilance and Benefit-Risk Management

PSURs are an essential tool in post-authorisation safety monitoring. They provide regulators and holders with a structured evaluation of whether new safety information affects the product's benefit-risk profile and whether any regulatory action might be needed (such as labelling changes, risk minimisation measures, or additional studies).
Source: Guidance on pharmacovigilance procedures (gov.uk)

6. Practical Considerations

Marketing authorisation holders should ensure that their pharmacovigilance systems are capable of collecting and analysing safety data continuously, feeding into PSUR preparation. Early planning facilitates timely report submission and effective engagement with the MHRA on safety issues.
Source: Guidance on pharmacovigilance procedures (gov.uk)

Conclusion

PSURs remain a vital element of the UK’s pharmacovigilance regime, supporting ongoing evaluation of medicinal products’ safety and benefit-risk balance. Compliance with submission requirements ensures that regulators have the information needed to protect public health.
Source: Periodic Safety Update Reports (PSURs) for medicinal products (gov.uk)