PV agreements and SDEAs for Swiss authorisations
Wherever safety information can reach someone other than you, a written agreement has to define how it gets to you and by when. An SDEA sets scope, the day 0 definition, exchange deadlines shorter than the regulatory ones, formats, responsibilities for literature and PSURs, audit rights, escalation and data handover.
- Last reviewed:
- Reading time: 4 min
- Reviewed by Swiss Pharmacovigilance
What is an SDEA?
A safety data exchange agreement is the contract that governs the flow of safety information between two parties. It can be a standalone document or an annex to a licence or distribution agreement, but it has to be specific: an agreement that says the parties will cooperate on pharmacovigilance is not an SDEA.
When you need one
The test is simple: could a safety report reach this party instead of you? If yes, you need an agreement, whatever the commercial relationship is called. That includes parties you do not think of as safety partners, such as a wholesaler running a customer hotline.
- Licensor and licensee, in both directions
- Distributor or local commercial partner for Switzerland
- CRO or pharmacovigilance service provider
- Co-marketing or co-promotion partner
- Wholesaler or logistics provider with customer or patient contact
- Market research or patient support programme vendor
- CH-REP for a medical device, on the vigilance chain
The ten clauses that belong in one
An SDEA that omits any of these will be tested by the case that needed it. The cascade deadline is the clause most often missing and most often needed.
- Scope: which products, which territories, which types of information.
- Day 0 definition, identical for both parties, and how it is evidenced.
- Exchange deadlines, cascaded shorter than the regulatory deadline.
- Formats and channels, including the fallback when a system is down.
- Language, and who bears the cost of translation.
- Responsibility for literature searching, and whose search covers what.
- PSUR contributions: who supplies which data, by when.
- Signal exchange: what is shared, in which direction, on what cadence.
- Audit rights, and the obligation to support an authority inspection.
- Escalation, termination and the handover of safety data on exit.
The deadline cascade by partner type
Cascading means the partner owes you the case well before you owe it to Swissmedic. One to three calendar days is the usual internal deadline, because you still need time to assess, code, follow up and release.
| Partner type | What they send | Cascade deadline | Who submits to Swissmedic |
|---|---|---|---|
| Licensor | Global cases, signals, PSUR inputs, label changes | 1 to 2 days for cases | You, for Switzerland |
| Licensee abroad | Cases from their territory | 1 to 2 days | They, in their territory |
| Swiss distributor | Cases and complaints received locally | 1 day | You |
| Service provider | Processed cases and submission acknowledgements | Per the SLA, before the deadline | They, on your behalf |
| Co-marketing partner | Cases for the shared product | 1 to 2 days | Each for its own authorisation |
| Wholesaler with hotline | Any safety information received | 1 day | You |
| CH-REP, device | Incidents and user feedback | Immediately, given the 2 day rule | Manufacturer or CH-REP |
Reconciliation: count, do not trust
Reconciliation means periodically comparing the number of cases your partner says it sent with the number you received, and investigating the difference. Quarterly is typical, monthly for a high volume partner. The output is a dated record with the counts, the discrepancies and what was done about them.
An unreconciled SDEA is a paper control
A signed agreement proves intent, not performance. Without reconciliation you cannot know whether a partner has been silently dropping cases, and neither can an inspector. Diaries, contacts and systems change on the other side without telling you.
Frequently asked questions
Is a clause in the distribution agreement enough?
Only if it is specific enough to operate: scope, day 0, cascade deadlines, formats, escalation and handover. A general cooperation clause is not an SDEA, and it will not tell anyone what to do when a serious case arrives on a Friday.
How short should the cascade deadline be?
Short enough that you can still assess, code, follow up and submit inside 15 days. One to three calendar days for cases is the usual answer, with immediate notification for anything fatal or life threatening.
Who submits to Swissmedic when a partner processes the case?
Whoever the agreement names, but the responsibility stays with the authorisation holder. If a provider submits on your behalf, have the acknowledgements forwarded to you systematically so your case file is complete.
Do we need an SDEA with a wholesaler?
If the wholesaler can receive safety information, for example through a customer hotline or complaint handling, yes. It does not need to be long, but it needs a forwarding obligation with a deadline and a named address.
How often should an SDEA be reviewed?
Annually, and whenever the products, territories, systems or contacts change. Review the document and the reconciliation record together, because an agreement that is current on paper but unreconciled tells you nothing.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.