Spring Intro 2023

Type II Variations: Procedure

 Type II “Tell, wait for approval and do” 1. MAH to notify Authorities prior to making the change ( TELL ) 2. Wait until receipt of approval letter from regulators – minimum Agency review time is 60 days ( WAIT FOR APPROVAL ) 3. MAH to implement the change ( DO ), as follows: i. MRP: 30 days after the MAH has been informed about the acceptance by the RMS (no need to wait for national updates of MAs) ii. CP: Whether you can implement on CHMP Opinion or wait for EC decision depends on change. Refer to regulation • If Agency wants more information, procedure may be extended and change should not be implemented until receiving approval from the regulators. • Can be grouped with other variations but grouping needs to be justified.

The Organisation for Professionals in Regulatory Affairs

21

Examples for Type II

Commission Regulation (EC) No 1234/2008 (the Variations Regulation) defines a major variation of Type II as a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product  Changes to specifications outside approved limits  Substantial changes to manufacture, formulation, specifications, impurities which could impact QSE  New Drug Substance or Drug Product manufacturing site for a Biological, where comparability needs demonstrating  New or modified design space

The Organisation for Professionals in Regulatory Affairs

22