CRED 8 Presentations

01/07/2024

Module 1.3.2 Mock-ups (for primary and secondary packaging)

• CP only: To facilitate assessment, only the proposed pack with the most text, ie “worst case” language combination for all presentations, is required, in English, in initial submission. Refer to Readability Guideline and Packaging Guideline . • MRP/DCP : provided usually in English only in initial MAA submission unless using Belgium (three Language country) as RMS/CMS then same requirements as CP. • Multiple Strengths/Presentations • CP a mock-up of the alternatives should also be prepared and submitted as the colours or alternate presentation needs to be complementary but distinguishable from the first. Smallest pack size only is required to illustrate alternatives. • MRP/DCP depends on national requirements.

The Organisation for Professionals in Regulatory Affairs

13

13

Module 1.3.4 Consultation with target patient groups i.e user testing (CP, MRP/DCP)

Plan for user testing well in advance of the initial MAA submission date. CP:

• Agree at EMA pre-submission meeting (if held) or in advance with EMA Product Lead: • Timing of the submission of UCR. Submission after D120 must be justified/agreed prior to submission • Any bridging report / or any plan for no User testing (e.g. if a biosim/ generic) with rationale. • The final User Consultation Report (UCR) should be submitted with responses to Day 120 questions as the Product Information may change significantly prior to then. • If submitting under Accelerated Assessment, then UCR is required at the point of submission MRP/DCP: • Include in initial MAA. • Content depends on what is currently available - spectrum from full user consultation report to simple bridging reports. • If considering using the multilingual pack (i.e multiple countries) a bridging readability report will be required on the worst case (only one language needs to be assessed and not EN). Submit for D160 latest.

The Organisation for Professionals in Regulatory Affairs

14

14