How do I know how many changes there are in my application?
If the variation application concerns several variations, a separate notification or application should be submitted for each variation. However, the variations may be grouped in accordance with Article 7 of Commission regulations 1234/2008 and 712/2012. For example, if the application concerns three different Type II C.1.4 subtype variations, these must grouped in one application containing three Type II C.1.4 subtype variations. Applicants should note that implementing changes made to the Company Core Data Sheet (CCDS) in product information may involve several separate variations. Applicants must clearly state the topic of each change on the application form. For clinical Type II variations a single variation refers to the actual change and other related changes or to consequential changes resulting from the actual change. CMDh has published explanatory notes on how to fill in the application form, examples for acceptable and not acceptable groupings, and questions and answers regarding groupings.
Please see separate instructions for submitting a summary of product characteristics in Swedish.