8. Post-Approval

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2. Variations

2.3. Type IA variations – ‘Do and Tell’ procedure

Such minor variations have only a minimal or no impact on the quality, safety or efficacy of the medicine, and do not require prior approval before implementation.

A guideline clarifies the conditions which must be met.

These minor variations are classified in two subcategories:

  • Type IA variations require immediate notification to the authority following implementation, in order to ensure the continuous supervision of the medicine.
  • Type IA variations that do NOT require  immediate notification may be submitted by the marketing authorisation holder (MAH) in an annual report within 12 months after implementation.

Annex II of Regulation (EC) No 1234/2008