How to review a PIF for missing evidence

Begin with the question the file must answer

A missing-evidence review starts by identifying the product, market and revision under consideration. It should not begin with an assumption that a large folder is complete or that every empty row represents the same kind of problem.

Use the main evidence areas in HPRA's PIF guidance as a starting structure, then have the specialist confirm the relevant requirements for the actual case. The exercise below organises that review; it does not issue a compliance finding.

Use three separate state questions

First, is a record present and identifiable? Capture its filename, version, date and product link. Second, has someone checked whether the contents address the intended question? Record missing sections or uncertainties rather than using an unexplained complete label. Third, has an appropriately scoped specialist review been recorded against the current product revision?

These states can differ. A report can be present but relate to an older specification. A supporting note can be administratively complete while the specialist still needs to evaluate it. Keep those differences visible.

Review the relationship between records

Check whether the description, assessment inputs, packaging information, artwork and other evidence refer to the same product version. Look for changes that have not been carried through to the associated review. Ask the relevant owner to resolve an unclear relationship rather than guessing which file is current.

Keep the source/provision behind each review question available. An internal checklist label does not establish the obligation or prove its interpretation. The specialist must confirm the legal scope and any exception or transition that matters to the product.

A synthetic gap log

Sample Product A has an identified description, an older assessment record and new artwork. The review log says: description present, relevance check pending; assessment present, version relationship unresolved; artwork present, new claim support not linked.

The resulting actions are distinct: confirm the assessed specification, review the new claim and agree whether the change requires further assessment. None of those actions is accurately represented by a general task saying upload more files.

Close with an auditable decision

Record who reviewed the evidence, what revision they considered, their findings and the limits of the review. Close the associated action with a reference to the outcome. If information is still missing, retain a named open question and owner.

CosmeBeacon resets the current review state when product details or evidence change, while preserving the earlier review history. This helps prevent an older decision being mistaken for a current one. It does not determine whether the underlying evidence is legally sufficient. Use the source and review information shown on this page when agreeing the scope of the exercise.

Sources and legal dates