Module 5 Presentations

18/07/2024

Issues related to manufacture, packaging and distribution of clinical supplies

The Organisation for Professionals in Regulatory Affairs

21

Non EU Countries & Comparators

• Commercial comparators sourced from outside the EU = Difficult for the QP

If EU comparator product is unavailable:- 1 st Choice = Source product from country with MRA 2 nd Choice = Source product from ICH Region 3 rd Choice = Source product from Third Country (methods, specifications, reference standards!) Note: Source must be compliant with CTA!

The Organisation for Professionals in Regulatory Affairs

22

11