CRED Managing Variations Effectively

Type IA variations: key points  Type IA variations have only a minimal impact, or no impact at all on the quality, safety or efficacy of the medicinal product.  Classification Guideline Type IAs precisely defined:  Changes are precisely defined  Conditions and documentation requirements  ‘Do and Tell’ 30-day procedure’ – Prior implementation  Categories of Type IA Notification – Timing of notification  Type IA Immediate – submit immediately after implementation.  Type IA – submit within 12 months of implementation  Annual Reports – when and how to submit  Grouping (3) of changes is possible within a single application Strategy (2) : procedural aspects

Strategy (1) condition and documentation requirements

105