CRED Managing Variations Effectively

National WS Example 2: WS procedures to harmonise the SmPC and PIL across MS

WS: Grouped Type II change code C.I.4 • To harmonise the complete Section 4 of the SmPC and the PIL by implementing a company core data sheet (CCDS) • Additional amendments in line with the latest QRD template • 3 products (different strength and form) updated (authorised purely nationally), but • Not every product is authorised in each country • 17 member states concerned • Outcome: SPC and PIL harmonised for 34 products in 17 countries in one procedure • Within a WS procedure, not all products (forms/strengths) have to be authorised in each country • After WS, harmonisation should be maintained

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