Disclosure preparation checklist and methodological-note guide

Confirm the reporting perimeter first

Create a country and entity register before requesting data. Identify who owns each return, which activities are covered and where the applicable requirements are recorded. Separate your internal data-collection deadline from the external submission and publication dates.

EFPIA’s 2026 Code addresses HCP/HCO disclosure in Articles 22–23 and Annex B. It requires a methodological note using the Annex B structure. Check national implementation rather than treating one European process as sufficient for every market. For the UK, ABPI Code Clause 28 addresses reportable transfers and methodological notes; its supplementary information identifies Disclosure UK and the required submission template.

Agree the precise period with finance and document which date controls recognition in the return. Do not silently combine payment-date and activity-date extracts. Ask each data owner to confirm their coverage, including activity administered outside the local affiliate.

Preparation checklist

Use these suggested checkpoints to create an accountable work plan. Mark an item complete only when its evidence and open questions have been reviewed. A blank amount, missing extract or unresolved classification should remain visible.

Reconcile before you format the return

Start with a source inventory covering the systems and suppliers used for the activities in scope. Give every extract a version and owner. Reconcile source totals to the preparation dataset, then explain exclusions, adjustments and any timing differences. Preserve original amounts and currencies alongside transformed values in your controlled working dataset.

Investigate duplicate-looking entries before deleting them. Two records may represent a genuine repeat payment, separate fee and expense components, or the same transaction reported by an agency and finance. Record the reason for each resolution so another reviewer can follow it.

Keep a query log with a named owner and due date. Escalate unresolved issues before the agreed freeze date. If a change arrives after approval, route it through change control and assess whether both the return and its methodological note need updating.

Draft the methodological note from the process you used

Follow the current applicable structure and explain your actual approach in plain language. EFPIA Annex B groups the note into definitions, scope, specific considerations, data-protection legal basis, form of disclosure and additional information. Its mandatory structure was to be implemented by the 2026 disclosure of 2025 transfers. Check every applicable sub-item in the official Annex when preparing the final note.

Use this guide and workbook for the full preparation process, including ownership, data checks and reconciliation. The separate methodological-note PDF template is for focused drafting of the public note. The workbook’s drafting sheet uses those six groups as prompts. Populate it with the approved company approach and evidence references, then reconcile the wording with the prepared dataset. It is a drafting aid, not a pre-approved note.

• Definitions: explain who and what the report covers.
• Scope: describe included entities and activities, recognition timing and exclusions.
• Specific considerations: explain relevant local and unusual arrangements.
• Data-protection legal basis: record the reviewed basis and how applicable recipient rights are handled.
• Form of disclosure: explain publication arrangements and financial presentation.
• Additional information: provide relevant clarifications and a route for questions.

Check the UK methodological explanation

ABPI Clause 28.6 calls for an explanation of the methodology and transfer categories, including recognition, multi-year arrangements, tax and currency treatment. Clause 28 also addresses lawful disclosure and aggregate reporting where individuals cannot be identified for legal reasons. Agree the relevant approach with the company’s privacy and compliance owners; consent should not be assumed to be the only possible basis.

As a practical review, select sample records and ask a colleague to follow the explanation from source through transformation to the return. Resolve contradictions between the note, system configuration and finance instructions before publication. Keep internal evidence references separate from text intended for public release.

Connect shared services and automation

Shared services can coordinate requests, prepare reconciliations and maintain exception logs under agreed procedures. Automation can check missing fields, flag possible duplicates and route queries. Define who approves changes to category mappings and who can release a return.

Test the workflow with awkward cases, including a late adjustment, conflicting recipient records and a replacement supplier extract. Check that the previous version can still be retrieved. An automated validation result should identify what was checked; it should not imply that every legal or classification question has been resolved.

The downloadable workbook includes a preparation checklist with status, owner and evidence fields, plus a methodological-note drafting sheet. It contains no recipient data and does not transmit entries to Eunomia. Use your approved systems for sensitive working records.

The people behind the support

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