Periodic safety update reports (PSURs) are a tool to monitor the ongoing safety of medicines post marketing (pharmacovigilance). They are submitted by the marketing authorisation holder (MAH) in respect of each authorised veterinary medicine, at defined intervals following the initial authorisation of the product. A PSUR is intended to provide an update of the worldwide safety experience of the medicine. PSURs are evaluated either by the IMB or by other EU medicines agencies operating a work-sharing system. PSURs are a tool to monitor the ongoing safety of medicines post marketing (pharmacovigilance).
In accordance with EU legislation (Directive 2001/82/EC as amended), the report should include information on the following types of adverse events (AEs) received during the reporting period, arising in the Community or third countries:
- Serious and non-serious AE reports in animals
- AEs reported in humans
- Available information on:
- Lack of expected efficacy
- AEs related to off-label use
- Investigation of insufficient withdrawal periods
- Potential environmental problems
PSUR Reporting Cycle
For newly authorised products, unless other requirements have been laid down as condition of granting of the authorisation, PSURs should be submitted at the following intervals:
- Every 6 months until placing on the market
Following placing on the market:
- Every 6 months for the first 2 years
- Annually for the subsequent 2 years
- Thereafter every 3 years
- Immediately upon request
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 PSUR work-sharing initiative is a project of the Heads of Medicines Agencies (HMA), supported by the International Federation for Animal Health (IFAH) - Europe and the European Group for Generic Veterinary Products (EGGVP). The initiative allows for all veterinary medicinal products with the same active substance, regardless of authorisation procedure used (mutual-recognition, decentralised or national), to follow the same PSUR submission cycle in all EU and EEA Member States. The submission cycle is based on a European Harmonised Birth Date (EU-HBD) and Harmonised EU Data Lock Point (EU-HDLP) per active substance. This allows industry to prepare one PUSR per product for simultaneous submission to all EU concerned member states, thus simplifying the PSUR submission schedule.
A HMA Q&A document for MAHs details the requirements for participation in the PSUR work-sharing initiative. Further information on the most up-to-date list of agreed EU-HDLPs for active substances, designated Originator MAHs and allocated P-RMSs responsible for the assessment of each PSUR per active substance can be found on the PSUR Synchronisation and Work-sharing section of the HMA website.
Submission of PSURs to the IMB
Electronic submission of PSURs is preferred. PSUR's can be submitted electronically in Word or PDF document format to IMBVETADR@imb.ie. MAHs may wish to consider using the EMA’s secure electronic ‘Eudralink’ system for submitting PSURs due to the confidential nature of the documents; however, this is not a requirement of the IMB. For details on how to register to use the Eudralink website please contact the Eudralink Helpdesk: firstname.lastname@example.org
Alternatively, hard copy PSURs should be sent to the following address:
Veterinary Sciences Department
Irish Medicines Board
Kevin O’Malley House
Companies are required to submit one copy of a PSUR unless otherwise requested.