There has been a change to the validation procedure for a variation to a Copycat Marketing Authorisation (MA).
A parent MA holder is responsible for notifying a Copycat MA holder when changes have been made to the parent MA and should provide the Copycat MA holder with at least the category used for the variation(s), and ideally the application number.
It is no longer acceptable for the Copycat MA holder to use the unforeseen Type IB-z category and the relevant category for the change concerned must now be used.
Type II variations
If a Copycat MA holder wishes to benefit from the allocation of a reduced (Type IB) fee and timetable, they must submit their variation within 2 months of issue of the parent variation, otherwise a full (Type II) fee and timetable will be applied.
Type II grouped change
A Type IB grouped fee will apply to the copycat MA.
Data should not be submitted with the Copycat variation. The application should rely solely on data already assessed for the Parent MA. If data is provided, a reduced fee and timetable will not apply.