Spring Intro 2023

Variations Guidelines –Classification of variations ● Variation guideline classifies many types of common changes: – >90 types of change/variation are listed. – Each change is assigned a classification category – Exact category is dependent on the type of change, type of product and whether certain pre-defined conditions can be met – Time for assessment, required supporting documentation and fee are dependent on category assigned ● Variation guideline covers: – Administrative changes – Quality changes (Drug substance, Drug product, Devices, CEP) – Safety, efficacy, pharmacovigilance changes – PMF/VMF

The Organisation for Professionals in Regulatory Affairs

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• The classification of a variation is defined by impact of the change on the quality, safety or efficacy of product • Classification of changes differ between countries

Line extension

Major Variation – Type II

Minor Variation – Type IB

Minor Variation – Type IA

Risk of potential to impact Quality/Safety or Efficacy Level of data and or justification to support change Times of review from agencies

The Organisation for Professionals in Regulatory Affairs

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