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1. Introduction
2. Summary of Product Characteristics (SmPC)
3. Package Leaflet (PL)
4. Package labelling
5. European Public Assessment Report (EPAR)
6. National registers of authorised medicines
7. Patients’ involvement in product information
8. What EMA publishes and when
1. Introduction
2. European Legislation – Directive 2001/83
References
3. Appendix I
1. Introduction
1.1. Definition of code of conduct
2. Levels of codes of conduct
3. Scope and topics of codes of conduct
4. Digital communication channels
5. Revision and limits
References
Assessment
1. Introduction ►