Safety monitoring of medicines

This page provides information for healthcare professionals and members of the public on how we monitor the safety of medicines.

Medicines bring many health benefits, and most of us use medicines at some point in our lives to treat or prevent illness and disease. However, it is important to understand that when a medicine is used, there is a possibility of experiencing a side effect.

The HPRA is responsible for monitoring the safety of medicines available for use in Ireland through pharmacovigilance.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities focused on ensuring the safety of medicines. It involves:

  • Detecting and Assessing: We gather and evaluate reports of suspected side effects from healthcare professionals, patients, clinical trials, and scientific literature.
  • Understanding and Preventing: By analysing this data, we aim to understand the risks associated with medicines and take steps to prevent or minimise these risks.

Why is Pharmacovigilance Important?

Pharmacovigilance is crucial for protecting public health. It helps us:

  • Identify potential risks associated with medicines,
  • Ensure that the benefits of a medicine outweigh its risks,
  • Keep healthcare professionals and the public informed about the safety of medicines
  • In exceptional cases, we may take action to suspend or revoke a medicine's license.

EU-Wide Cooperation

The HPRA is designated in legislation as the competent authority responsible for pharmacovigilance in Ireland.

The HPRA collaborates with medicines agencies from each member state across the EU. Working together maximises knowledge, resources, and expertise to monitor medicine safety robustly.

The European Medicines Agency (EMA) coordinates the scientific expertise of national authorities across the pharmacovigilance network. This cooperation allows for regulatory action if new side effects or new aspects of known side effects are identified.

Pharmacovigilance Risk Assessment Committee (PRAC)

The PRAC is the EMA's safety committee responsible for the risk management of medicines across the EU. Established in 2012, the PRAC assesses all aspects of risk management for human medicines, including:

  • Detection, assessment, minimisation, and communication of side effect risks, considering the therapeutic effects.
  • Design and evaluation of post-authorisation safety studies.
  • Pharmacovigilance reviews.

The PRAC comprises experts from each EU member state and the European Commission. Ireland is represented on the PRAC by the HPRA. The European Commission also appoints independent scientific experts and representatives from patient organisations and healthcare professionals.

The PRAC meets monthly to issue recommendations for the safe and effective use of medicines. The EMA publishes the agendas, highlights, meeting minutes, and recommendations from each PRAC meeting on its website.

Legislation and Guidance

Pharmacovigilance legal requirements are set out in EU and national legislation, detailing the roles and responsibilities of involved parties and how systems should operate. Key regulations include:

  • Regulation (EC) No. 726/2004
  • EU Directive 2001/83/EC (as amended)
  • Implementing Regulation (EU) No 520/2012

These regulations have been transposed into Irish law by S.I. No. 272 of 2012 (Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012), amending the Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007).

The EMA and member states have developed Good Pharmacovigilance Practice (GVP) guidelines to detail how legal obligations are met. Medicines agencies and the EMA continually monitor the safety of medicines in accordance with these guidelines, which are updated in line with scientific developments.

Pharmaceutical companies holding a medicine's license (marketing authorisation holders) also have legal responsibilities for pharmacovigilance. They must comply with legislation and GVP guidelines.

Key Pharmacovigilance Tools

Below is a description of some of the key tools used to perform pharmacovigilance. For further details on any tool, please refer to Good Pharmacovigilance Practice.

Risk Management Plan (RMP)

Pharmaceutical companies must submit an RMP for new medicines before they are approved. The RMP provides an overview of a medicine's safety profile, any plans for new studies to assess the medicine’s profile further, and ways to prevent or minimise risks. It is updated as new information on the medicine emerges over time.

Reports of Suspected Side Effects

The HPRA operates a system through which reports of suspected side effects can be made. We encourage the public (e.g. patients and carers) and healthcare professionals to report suspected side effects through this system. Reports are carefully reviewed and help gather more information about medicine use. Learn more about side effects and how to report them to the HPRA.

Post-Authorisation Safety Studies (PASS)

PASS collects more information on the safety profile and management of risks of approved medicines. Medicines agencies or the EMA can request pharmaceutical companies to conduct PASS, or companies may do so voluntarily. More information is available on the ENCePP Home Page.

Periodic Safety Update Reports (PSUR)

After approval, companies must submit PSURs at defined intervals (e.g., every 1, 3, or 5 years). PSURs critically analyse a medicine's risks and benefits, including new safety information. Medicines agencies may recommend measures to ensure continued safe use, which are legally binding across the EU.

Safety Signals

A safety signal is information on a new or known side effect that requires further investigation. Signals can come from various sources, including public reports, clinical studies, or scientific literature. The EU's coordinated signal management system thoroughly examines signals to determine causal relationships. Regulatory recommendations are made to ensure safe use if a new risk is identified.

Additional Resources

Learn more about the tools used to monitor medicine safety on the EMA's website.

The outcome of pharmacovigilance reviews undertaken by the EMA’s PRAC, in which the HPRA participates, are also available on the EMA's website.