Find the product-file task you need

A PIF is easier to work with when the next question is specific. You may be building a first index, checking whether the documents describe the current product, or preparing questions for a safety assessor. Those are different jobs. Start with the job, then record the market and product revision.

For Ireland/EU, the HPRA PIF guidance is the primary starting point. For Great Britain, use the GB guidance. Northern Ireland has a separate government route. A document directory does not establish that a file is suitable for every destination.

Start with the structure

Choose D01, What belongs in a cosmetic PIF?, if you need an evidence-area index. Work through one named product and create a reference for each document. The output is an organised view of the record, including blank spaces where evidence has not been found.

Choose D02, CPSR versus PIF versus SDS, if you are unsure what a supplied document does. Its diagram shows the relationship between the wider file, the safety report and supplier information. Identifying a document correctly comes before judging whether it answers a review question.

Choose D03, the synthetic Product A example, to see how an incomplete index can remain useful. The example has open questions and does not serve as a compliant specimen.

Review a file you already have

Choose D09, How to review a PIF for missing evidence, if files are present but their relevance or completeness is uncertain. Compare the product revision, document version and reviewer scope separately. An old review attached to an earlier specification should remain visible as history.

Choose S02, the assessor handover organiser, when you need a cover sheet, attachment references and a question log for the actual assessor. An administrative handover does not provide the assessor's conclusion.

Use a working organiser

T02 is the canonical PIF index download page. It contains a blank file, a deliberately incomplete synthetic example and a field guide. Start with the blank file for real work. Keep the synthetic example beside it only as an explanation of the fields.

The resource list shows the pages currently available for the selected market. A task named here without a released link is still awaiting publication. Choose the official authority branch when a reviewed CosmeBeacon resource is unavailable.

Finish with an owned question

Before leaving the index, record one next action: the exact question, the missing document or decision, who will obtain it and which product revision it concerns. That gives the later specialist review a useful starting point without turning a folder count into a compliance result.

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.

GOV.UK / OPSS: GB guidance: scope, Responsible Person, PIF, safety information and assessor responsibilities

Great Britain · Version: Current official web guidance retrieved 16 October 2026 · Retrieved: 2026-10-16 · Legal effective date: See the legal-date basis below

Source type: Official guidance

The guidance publication date and retrieval date are not substituted for the legal effective dates of the relevant GB provisions.

GB is separate from NI. Current amended law and case-specific exceptions are not inferred from this summary.

GOV.UK / OPSS: Northern Ireland technical guidance: territorial scope and separate market questions

Northern Ireland · Version: Official page shown updated 29 June 2026; retrieved 16 October 2026 · Retrieved: 2026-10-16 · Legal effective date: See the legal-date basis below

Source type: Official guidance

A guidance update date is not treated as the commencement date of every rule it describes.

Qualifying-goods and cross-market questions require a specific review; no blanket NI-to-GB outcome is asserted.

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