This guidance aims at supporting applicants in completing the ‘Precise scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)’ (hereinafter called the ‘Precise scope’) section of the Application Form for Type I and Type II variations.
It provides guidance on the information to be included in this section and some examples of changes applied for each of the scopes listed in the Guidelines on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing
authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures (hereinafter called ‘the Variations Guidelines’).
It also aims at improving the description clarity of the exact change(s) applied for and, ultimately, to facilitate the EMA validation and review process of the applications.
This guidance is not mandatory, it is rather meant as support for the preparation of applications for variations in addition to the EMA/CMDh explanatory notes on variation application form, the CMDh Q/A-List for the submission of variations according to Commission Regulation (EC) 1234/2008, the EMA practical guidance on application form for centralised Type IA and Type IB variations and the published pre-notification checklists for Type IAs, Type IBs, Type II quality variations and Type II (non) clinical variations.