If you have an application in process with the MHRA and need to submit a variation, you can apply for changes that may impact the product's quality, safety, or efficacy. Variations can be classified as minor (Type IA or IB) or major (Type II), and the specific procedures depend on the nature of the change
A variation in an MHRA application does not necessarily indicate a material event; it refers to changes in the marketing authorisation that can affect the product's quality, safety, or efficacy. Variations can be minor or major, depending on their impact on the product.