Signal management

This page outlines the responsibilities marketing authorisation holders must carry out to monitor the safety of their products. 

What is signal management?

Signal management is a process where marketing authorisation holders (MAHs) must monitor all their veterinary medicines throughout the year. They should record their findings on benefit/risk balance of the product at least annually on the Union Pharmacovigilance Database. This is in line with Article 75 of Regulation (EU) 2019/6. The signal management process consists of, but is not limited to, signal detection, prioritisation, validation, assessment and recommendation for action.

What is the aim of signal management?

The goal is to quickly detect any new safety issues that may change the benefit/risk balance of the product. New safety issues may include a new risk associated with the product or the active substance, or a change to a known risk. This means that regulatory action and communication can be taken by MAHs, National Competent Authorities (e.g. the HPRA) or the European Medicines Agency if necessary.  Regulatory action can involve additional monitoring of a product, a change to the product information, circulation of a communication to vets or animal owners or removal of a batch of product from the market.

Reporting responsibilities

If a new safety issue is identified during their signal management process the MAH must submit a signal to the Union Pharmacovigilance Database within 30 calendar days. A signal may relate to one product or to an active substance affecting multiple products. If there is a change to the product information then the MAH must submit the appropriate variation category.. 

Signal management also applies to MAHs that have been granted a marketing authorisation for veterinary medicines for certain species kept exclusively as pets. This is in line with Article 5(6) of Regulation (EU) 2019/6.

For more detailed information on the signal management process MAHs should consult the Guideline on veterinary good pharmacovigilance practices module on signal management.

Signal management in the HPRA

The HPRA has an important role in the monitoring and assessment of signal management. We assess signals submitted by MAHs and record the regulatory outcome on the Union Pharmacovigilance Database. We work closely with the European Medicines Agency and other EU regulatory agencies to make sure there is a consistent approach to the evaluation of signals.