Draft format of the supplier dossier series
Consultation on the format of the supplier dossier series: what a dossier contains, in what order, and what it declines to contain. The draft fixes a common structure so that two dossiers can be read against each other, and excludes any field the Institute…
§1Consultation and window
§1.1Window
- Opened
- 27 January 2024
- Closed
- 27 March 2024
- Duration
- 60 days
- Status
- Closed — the disposition is published
- Document under consultation
- Document series
- Submissions received
- 10
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the fixed structure workable across suppliers that differ substantially in the documentation they publish?
- Should a dossier record a field the Institute could not verify, marked as unverified, or omit it?
- Is the relationship between a dossier and the rubric score stated clearly enough for a reader who arrives at the dossier first?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The series format was ratified with amendments. An unverifiable field is now recorded and marked rather than omitted, because an omission is indistinguishable from an absence, and the rubric relationship is stated at the head of every dossier.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.