Re-evaluating Benefits and Risks

1. Periodic Safety Update Reports (PSURs)

A Periodic Update Safety Report is a cumulative report on the safety of a medicine which is prepared for a specific period of time. It provides an opportunity to re-evaluate the safety profile of a medicine and to review any new safety information that has been reported. Pharmaceutical companies are legally required to prepare PSURs for all authorised medicines regardless of marketing status which are then assessed by HPRA either nationally or in collaboration with other regulatory authorities in other member states in the EU. Following assessment of the information provided, updates to the product safety information may be considered necessary or safety concerns may arise which requires further consideration in the context of a safety referral at European level.

2. Safety Referrals

A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.

In a referral, the European Medicines Agency is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. The medicine, or the class or medicines, is ‘referred’ to the Agency so that it can make a recommendation for a harmonised position across the EU. There are a number of reasons why a referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine:

Safety–related referrals are assessed by the Pharmacovigilance Risk Assessment Committee (PRAC), and then either by the Committee for Medicinal Products for Human Use (CHMP) or, if a medicine is nationally authorised, by the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh). All other referrals on human medicines are assessed by the CMHP only.

Referrals can be started by the European Commission, any Member State or by the company that markets the medicine.

For most referrals, the European Commission issues a decision to all Member States reflecting the measures to take to implement the Agency's recommendation.

3. Renewals

The licence for a medicine can be extended by a renewal application. This provides an opportunity for review of the safety aspects of the medicine and to consider if benefits outweigh risks.