How to update a notification after a change

Direct answer: Trade name, packaging, classification or a composition shift within the declared ranges: submit an update referencing the previous PCN number. A composition change that moves a component outside its declared range or adds or removes a component: generate a new UFI and submit a new notification. Updates must be made before the changed product is placed on the market.

Update

Changes that keep the same formulation: new or extra trade name, new pack sizes, label element changes, a corrected toxicology text, a new country. The update keeps the same UFI and PCN number and states the reason for updating.

New notification

A new composition is a new formulation: new UFI, new PCN number, new label. The old notification stays on file for the product already in the market.

Grey area

Composition drifts within the declared concentration bands do not require anything. Drifts across a band boundary do. Keep the declared bands narrow enough to be honest and wide enough to cover normal production variation.

Practical

Keep a register per product: UFI, PCN number, submission number, declared composition, markets. Every update starts from that record. PCN Ready keeps a version history per formulation so an update dossier always references the right previous number.