Submit changes to labels and Patient Information Leaflets as a self-certification

Regulation 267 of the Human Medicines Regulations (2012) sets out the requirement for the submission of mock-ups of packaging and leaflets to the licensing authority, as part of an initial licence application and subsequently to register any changes that are not connected with a change to the Summary of Product Characteristic (SmPC). The default route for registering changes to the label and/or leaflet is via a self-certification, unless the proposed updates fall into the categories P1-P4, where a full assessment is required.