CRED Managing Variations Effectively

National WS, MHRA experiences: Pitfalls, deficiencies raised at assessment

Example 3:Type IB WS Eye drop product, new pack size of 5 ml Ref Authority sends request for further information (RFI): • The new pack size is acceptable, however • Differences are noted between the submitted “approved” FPS and the actual registered FPS • Additional named impurity • Different preservative limits • There is no record of variation submitted for the above • Further variation may be required to address this • It is unclear if Module 3 is the same in each country Concerned MS comments (Day 55): similar issue in their national MA

• Purely national WS: tabulated present vs proposed reflecting situation applicable to all MAs across all countries included in WS  important

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