VI.App.3.3. Requirements applicable to competent authorities in Member States
Location:
VI. Appendix 3
Table VI.8. ICSRs submission requirements applicable to competent authorities in Member States
| 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 | EU | All non-serious | EudraVigilance database | 90 days |