CRED Managing Variations Effectively

27 Documentation to Support Variations 1. Cover letter (templates available from CMDh and EMA) 2. Application form – (use standard form otherwise fail validation!) ● Scope and background ● Present and proposed table is critical ● Implementation dates • Type IAs must be within the last 12 months (unless grouped with higher category variation) • Type IAINs must be notified (submitted) immediately following implementation • Type IBs must be in the future 3. Copy of relevant pages of Commission Guideline showing conditions and documentation requirements are met for Type IA and Type IB (or copy of Article 5 recommendation received) 4. Supporting data/documentation • Amended CTD components where relevant • TIP: Generate CTD components with tracked changes first, to aid completion of the application form’s “present and proposed” section • For Type II variations need an updated Mod 2 QOS or an addendum to the QOS • Note: The supporting data does not always need to be incorporated into CTD components, and may need to make a judgement call on how to present (based on future life cycle flexibility).