Labeling Strategy and Regulatory Liaison
Prior to submission:
- Establish English Product Information
- Prepare mock-ups in English and a multi-lingual worst case combination (e.g. Belgium with French, German, Dutch)
Prior to Opinion:
- Update English Product Information during the Health Authority review
- Translate and proofread in all current EU languages
Post-Opinion:
- Implement changes made to the English version at Opinion, into all language versions (5 days-timeline)
- Implement linguistic comments from individual Members States into the corresponding language versions; this step often involves liaison with CHMP members (3 days-timeline)
- prepare mock-ups as required prior to product launch, including clarification of Blue Box content
Readability Testing of package leaflets (PL) prior to submission or in early Health Authority review phase
- Optimize the PL with regard to readability
- Establish PL mock-up
- Develop structured questionnaire focusing on critical areas of the PL
- Recruit appropriate target groups
- Execute Readability User Testing by conducting face-to-face interviews performed by trained, experienced interviewers
- Evaluate results
- Implement test results in the PLs (including mock-up)
- Prepare final report for Health Authorities
