Variations are usually required when the company wish to update or modify an existing aspect of an already authorised product, avoiding the process of a new application. This may involve changes to the terms of its labelling, formulation, or indication. A supplement, on the other hand, seeks to add a new specification, for example, an extended use of the product, expanding its market, etc. We navigate the scientific and regulatory complexities to ensure that changes are well justified and the impact on the final benefit-risk balance of the product is clearly communicated.