From 28 January 2022, periodic safety update reports (PSURs) are no longer required under the new veterinary Regulation (EU) 2019/6. Only PSURs submitted to the HPRA prior to 28 January 2022 will be assessed, i.e., those submitted on or after 28 January 2022 will not be assessed.
Responsibilities of marketing authorisation holders to carry out signal management
Under Regulation (EU) 2019/6 marketing authorisation holders must carry out continuous signal management throughout the lifecycle of their veterinary medicinal product(s), based on adverse event reports received in respect of those product(s).
Marketing authorisation holders should continuously monitor the safety of their veterinary medicinal products, in order to promptly detect any new safety issues that may impact the benefit/risk balance so that adequate regulatory action and communication (where necessary) can be taken in coordination with the competent authorities and/or the European Medicines Agency. New safety issues may include a new risk associated with the product or the active substance or a change to a known risk.
Guidance on veterinary good pharmacovigilance practices (VGVP guideline) consisting of six modules, including one specifically addressing signal management, has been developed and is available on the veterinary regulatory section of the EMA website.
At least annually, marketing authorisation holders need to record the outcome of the signal management process and their conclusion on the benefit/risk balance for each of their products in the Union Pharmacovigilance Database.
Note that the same pharmacovigilance requirements (including signal management) that apply to marketing authorisation holders also apply to holders of registrations of homeopathic veterinary medicinal products and veterinary medicinal products authorised in accordance with Article 5(6) of Regulation (EU) 2019/6 (certain species kept exclusively as pets).
Signal management process and reporting responsibilities
The identification of new risks associated with a veterinary medicinal product should be based on the detection and analysis of signals, in accordance with the signal management process. The signal management process consists of, but is not limited to, the pharmacovigilance activities of signal detection, prioritisation, validation, assessment, and recommendation(s) for any action.
Signals detected by the marketing authorisation holder, regardless of the source, should be handled according to the principles outlined in the VGVP module on signal management.
An Emerging Safety Issue (ESI) is defined as any new information which might influence the assessment of the benefits and the risks of a veterinary medicinal product and which may require urgent regulatory action and communication. It should be reported to the relevant competent authority, without delay and no later than three working days after its identification.
Where the outcome of the signal management process identifies a change to the benefit/risk balance or a new risk, the marketing authorisation holder shall notify it without delay and no later than 30 calendar days to competent authorities, and where necessary submit a variation to the terms of the marketing authorisation.
Note that as part of their annual submission, marketing authorisation holders are required to confirm that the signal management procedure has been conducted and all assessed signals have been submitted. Further information on the annual statement can be found in section 3.2.2 of the VGVP Module on Signal Management.
Evaluation of signal management by the HPRA
The HPRA has an important role in the monitoring and assessment of signal management:
The evaluation of signals that are submitted continuously throughout the year by the marketing authorisation holders, which require further regulatory action.
The review of annual statements by marketing authorisation holders on the benefit/risk balance of their veterinary medicinal product(s) together with the validated signals assessed throughout the year, which did not require urgent attention or did not lead to any proposals for further regulatory action.
The HPRA will work closely with our colleagues in other regulatory agencies and the European Medicines Agency to facilitate a harmonised and shared approach to the evaluation of signal management.