How to organise a digital PIF folder

Build a folder that another person can navigate

A digital product information file needs a reliable route from the product on the shelf to the evidence used for its review. Begin with a stable product identifier, a named record owner and the intended sales market. A folder called final-final does not establish which formulation, artwork or assessment it contains.

For Ireland/EU, Article 11 of Regulation 1223/2009 addresses the PIF, including accessibility in electronic or other format. The HPRA PIF overview describes its main components. The folder proposal below is an organisational example, not a prescribed legal format or a finding that those components are complete.

Start with the index, then the folders

Keep one index at the top level. For each item, record its document identifier, title, issuer, revision, issue date, file location, applicable product revision and review state. Add the specific unresolved question where an item is missing. The index should show what the reviewer can inspect today, rather than only the documents somebody intends to obtain.

Group working records by purpose: product identity and formulation; supplier evidence; safety information; manufacture; artwork and claims; and review decisions. Agree the legal contents with the specialist. Put a short explanation beside any empty section so an absent file is not mistaken for an irrelevant requirement.

Synthetic Product A: changing the formula

Product A is a fictional face cream with product identifier SAMPLE-A. Its formulation changes from revision 2 to revision 3 while artwork revision 4 is still being prepared. Retain the revision-2 index and its referenced files. Create a new working index for revision 3 and identify which records are reused, replaced or awaiting review.

Use a name such as SAMPLE-A_FORMULA_r03_2026-10-16.pdf. Keep the issuer's original name in the index where the local filename differs. Do not change a supplier's issue date to the date you downloaded its file. Link an artwork record such as SAMPLE-A_ARTWORK_r04 to formulation revision 3 explicitly; matching numbers are not required and should not be assumed.

The working folder-layout file shows this example. Its names and empty placeholders are synthetic. A folder called reviewed contains only a saved decision and the evidence references within its scope; moving a file there does not confer approval.

Give access for the task

Use named access where the chosen document system supports it. A maker maintaining the index may need edit permission; an external assessor may need access to a defined review bundle; a packaging designer may need only the artwork and correction record. Avoid sharing formulation files through a public link merely because the artwork review is urgent.

The access example records intended permissions and the check needed to confirm them. It does not demonstrate permissions in a real storage account. Test the recipient's actual view and revoke access when the agreed task ends. Keep the Responsible Person's access arrangements separately documented.

Verify the handover

Open the index from the recipient's view, follow several file links and confirm the product revision. Check that a withdrawn file remains distinguishable from its replacement. Agree backup, recovery, retention and authority-access arrangements with the record owner and specialist; a successful cloud upload answers none of those questions on its own.

Great Britain has a separate official PIF route. Keep GB and Northern Ireland scope decisions separate instead of renaming an Ireland/EU folder UK. Return to the PIF task index, D00, for the next evidence question, or use the product-evidence workflow to record the exact version being handed over. Links to unreleased guides remain unavailable until review and publication.

Sources and legal dates