VI.App.3.2. Requirements applicable to marketing authorisation holders
Location:
VI. Appendix 3
Table VI.7. ICSRs submission requirements applicable to marketing authorisation holders
| Marketing authorisation procedure | Origin | Adverse reaction type | Destination | Time frame |
|---|---|---|---|---|
| Centralised | EU | All serious | EudraVigilance database | 15 days |
| Mutual recognition, decentralised or subject to Article 58 | EU | All non-serious | EudraVigilance database | 90 days |
| Purely national | Non-EU | All serious | EudraVigilance database | 15 days |