ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Presentation of Results (Guideline) |
|---|
| 1.3.4. Consultation with target patient groups |
| 1. Product Description |
| 2. Consultation or test details, such as: |
| · Method used |
| · Explanation on the choice of population consulted |
| · Language(s) tested |
| 3. Questionnaire |
| (including instructions and observation forms) |
| 4. Original and revised package leaflets |
| 5. Summary and discussion of results |
| (subjects’ answers, problems identified and revisions made to relevant package leaflet section) |
| 6. Conclusion |
Source: European Commission (2009) Guideline on the readability of the labelling and package leaflets of medicinal products for human use (Revision 1)