PSMF
The pharmacovigilance system master file: its current version, when it was issued and when it is next reviewed, and a record of any annex changed outside the scheduled review. · Next scheduled review 4 Nov 2026
The master file
The version in force and when it was issued. Its next scheduled review is the one PSMF date on the Horizon page and in the reminders.
History
- 4 Oct 2026, 15:14Created · system
- 4 Oct 2026, 13:50Created · system
Annexes
| Annex | Changed outside the cycle | Trigger | Logbook note | Actions |
|---|---|---|---|---|
| A — QPPV | 15 Aug 2026 | Change of deputy QPPV | Annex A reissued with the new contact details. | Open: A — QPPV |
| B — Organisation | Open: B — Organisation | |||
| C — Sources of safety data | Open: C — Sources of safety data | |||
| D — Computerised systems and databases | 14 Sept 2026 | New distribution agreement | Annex D updated with the new partner and the exchange timelines agreed. | Open: D — Computerised systems and databases |
| E — Processes | Open: E — Processes | |||
| F — System performance | Open: F — System performance | |||
| G — Quality system | Open: G — Quality system | |||
| H — Products | Open: H — Products | |||
| I — Logbook | Open: I — Logbook |