Product Information Update (PIU)

What is a PIU?

A PIU is a communication to healthcare professionals. It gives details of important changes that have happened to the product information of a medicine. In particular, it gives details of changes that might impact how a medicine is prescribed or dispensed.

PIUs are provided by the Marketing Authorisation Holder (MAH) of the medicine in agreement with the HPRA.

• The MAH sends PIUs to healthcare professionals who are most likely to be impacted by the changes to the product information.
• The PIU is then published on the HPRA website.

When should a PIU be considered?

A PIU can be considered following any change to the product information that might impact how a medicine is prescribed or dispensed. A PIU is usually sent following a Type II variation that has made significant changes to indications, posology (dose) or contraindications of the product information. A PIU is usually a requirement when there has been a change in the method of sale and supply (MoSS) of a medicine, for example a change from prescription only status to over-the-counter status.

• Direct Healthcare Professional Communication (DHPC): Gives healthcare professionals information about new safety issues.
• Caution in Use Notification (CIUN): Gives healthcare professionals information about quality defects when product recall action is not possible or needed.

PIUs are usually considered during a variation procedure that is proposing changes to indications, posology or contraindications of the product information. 

All queries and communications concerning PIUs should be sent to the case administrator of the related variation. For PIU queries that are not related to an ongoing or recent variation, contact HPRA Customer Services at info@hpra.ie.