Updating Product Information - Safety Variations
The safety profile of a medicine can change throughout its lifecycle as new safety information emerges. New safety information can arise from a number of different sources including the conclusions of a PSUR or as the outcome of a PRAC signal assessment. In certain cases a change to the product information may be warranted to reflect the updated safety information which involves updating the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). The pharmaceutical company is responsible for submitting an update to their product information as a variation to its licence which must occur in a timely manner. This ensures that the product information for a medicine contains the most up to date safety information.
Updating Product Information - Product Information Updates (PIU)
What is a PIU?
It is sometimes necessary to communicate with healthcare professionals, in order to highlight changes to the product information or other significant issues in relation to medicines. The HPRA has decided to call these communications Product Information Updates (PIUs), in order to distinguish them from other communications.
A product information update (PIU) is a communication with healthcare professionals providing details of important change(s) to product information that may impact on prescribing or dispensing of medicines. PIUs are sent to relevant healthcare professionals depending on the subject matter.
A PIU differs from:
- a direct healthcare professional communication (DHPC), which provides healthcare professionals with information regarding new and emerging safety issues.
- a Caution in Use Notification (CIUN), which is used to highlight quality defects and when product recall action is not possible or not warranted e.g. the medicine is critical in nature and cannot be recalled or when clarification is needed on incorrect or missing product information.
When should a PIU be considered?
A PIU should be considered:
- Following the outcome of a referral procedure (Article 30 or 31) or a Paediatric Regulation Article 45 or 46 procedure, which results in changes to sections 4.1, 4.2, 4.3 of the Summary of Product Characteristics (SmPC);
- Following the outcome of a Type II variation resulting in changes to indications, posology or contraindications;
- Following the outcome of a Type II switch variation resulting in the first change in the method of sale and supply (MoSS) of an active substance.
Further information can be found in the 26th edition of our Newsletter