Periodic Safety Update Report

Guidance for Marketing Authorisation Holders (MAHs) on PSUR requirements.

Periodic safety update reports (PSURs) provide an overview of the worldwide safety experience of a medicine during a defined period.  They are prepared for each authorised veterinary medicine by the marketing authorisation holder (MAH).  We use the information in PSURs to continuously assess the benefit-risk balance of the veterinary medicine after they have been authorised for use.

In accordance with EU legislation (Directive 2001/82/EC as amended), a PSUR should include information on all adverse events (AEs) that occurred after use of the veterinary medicine during the reporting period.  Detailed information on the content and structure of PSURs can be found in Volume 9B of the Rules Governing Medicinal Products in the European Union.

How to submit PSURs to HPRA

PSURs can be submitted as a Word or PDF document to vetsafety@hpra.ie.  MAHs are required to submit one copy of a PSUR (unless otherwise requested). Due to the confidential nature of PSURs, you can avail of the EMA’s secure electronic ‘Eudralink’ system for submission; however this is not a requirement.  For Eudralink registration information please contact the Eudralink helpdesk eudralink@ema.europa.eu 

PSUR Submission Cycle

For most newly authorised products, PSURs should be submitted every 6 months until initial placing on the market.  Following placing on the market they are submitted:

  • every 6 months for the first 2 years;
  • annually for the subsequent 2 years; and
  • thereafter every 3 years.

 

For some products, alternative PSUR reporting requirements may be laid down as condition of granting of the authorisation, or their PSUR submission cycle will follow the PSUR work-share cycle.  If there is a safety concern for a veterinary medicine, submission of a PSUR may be requested immediately.

Each PSUR should be submitted within 60 days after the Data Lock Point (DLP).  Non-submission of a PSUR may lead to regulatory actions.

PSUR Work-sharing Initiative

The Heads of Medicines Agencies (HMA) initiated a PSUR work-sharing project to synchronise the PSUR submission cycle for some veterinary medicines.  The initiative applies to veterinary medicines with certain active substances (or combinations), authorised via mutual-recognition, decentralised or national procedures. It does not apply to immunological products. The submission cycle for these PSURs is based on a European Harmonised Birth Date (EU-HBD) and Harmonised EU Data Lock Point (EU-HDLP) per active substance. This allows MAHs to prepare one PSUR per product that can be submitted to all EU Member States where the concerned product is authorised at the same time, thus simplifying the PSUR submission schedule.

Information, including the list of active substances, EU-HDLPs, designated Originator MAH and P-RMS per active substance can be found on the PSUR Synchronisation and Work-sharing section of the HMA website.

If you want to participate in the PSUR work-share project, please contact vetsafety@hpra.ie for information.