An index for a product information file review

This pack helps organise a product-specific PIF review. It contains a blank index, a synthetic completed index and a short field guide. It is not a completed PIF, a CPSR, a legal opinion or an assessor-signed document.

HPRA's PIF guidance provides the starting structure. The specialist must verify the actual provisions, applicability and evidence for the product and destination market before relying on the record.

Keep the evidence states distinct

The index separates the evidence area, the precise question, the document reference, the product/version link, file presence, completeness and specialist findings. It also records the owner, next action and review date. An attachment count is not a completion score.

Use the rows to identify relationships as well as gaps. A document can exist but concern an earlier version. A supplier attachment can provide useful information without answering the finished-product question. Record those limits rather than changing the status to complete to tidy the sheet.

Read the synthetic example first

Sample Product A has a description, supplier material and draft artwork. No current assessor-signed report is recorded. Manufacturing and claim-support questions remain open. The example shows how to retain those questions and give them owners; it is deliberately not a compliant specimen.

Use the example to understand the fields, then start a separate blank working copy for the real product. Do not replace sample names with a real brand and treat the result as a reviewed file. The substantive evidence must concern the actual product.

Prepare the specialist review

Confirm the product and revision under consideration, gather the relevant material and ask the reviewer to identify missing information and scope limits. Record findings against the exact version. Preserve the prior decision when the record changes.

The source/retention fields should identify the applicable basis and trigger, not simply the day the spreadsheet was created. Cross-market and changing-product cases need their own review rather than an assumed extension of this index.

Use the downloads together with the page's sources, version, review information and stated limits. Keep the synthetic example separate from the real product's evidence. A completed index is an organisational record, not an automatic approval.

Sources and legal dates

HPRA: PIF guidance: product-specific file, components and retention; cross-check current Article 11 before publication

Ireland / EU · Version: Live web guidance retrieved 16 October 2026 · Retrieved: 2026-10-16 · Legal effective date: See the legal-date basis below

Source type: Official guidance

Do not infer a legal date from the web retrieval date. The legal basis and applicable dates require Frances's review.

Retention triggers, version scope and cross-market applicability need specialist confirmation.

Related next steps

Reviewed downloads

Blank PIF review index

Blank · Page revision 2 · 1 KB

Download pif-index-blank.csv ↓

Synthetic incomplete PIF index

Synthetic example · Page revision 2 · 2 KB

Download pif-index-synthetic.csv ↓

Scope, field guide and use instructions

Instructions · Page revision 2 · 1 KB

Download read-me.txt ↓