A one-day training workshop on EU Variation Guidelines as adopted by SAHPRA


  1. Introduction/Definition
  2. Understanding variation classifications
  3. Presentation of variations to facilitate review
  4. Grouping of variations
  5. Variations to multiple products
  6. Unforeseen variations
  7. SAHPRA Variations Addendum for Orthodox Medicines

Not in scope:

  • Clinical Variations
  • Biological medicines
  • Complementary medicines