Module 18 2021

07/02/2021

Article 10b

 FIXED COMBINATION

● Only acceptable if – Each individual drug substance has been authorised in the EU – …and the twist:

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Article 10c

 INFORMED CONSENT

● Requires that the MA holder of the reference product gives permission to cross reference to the data in their MA – Cross reference is applicable to Modules 3, 4 and 5 – It will always be linked to the reference product – permanent access to the reference product documents – This route is usually a method for companies to obtain a duplicate license for an existing product which they can use for licencee agreements/alternative branding, for example.

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