Choose a record for the task in front of you

A useful template makes an unresolved question easier to see. It should tell the next person which product, market and document version you mean. Filling every cell is not evidence that the underlying work has been completed.

The resources below are administrative organisers. Each template page has a blank download, a wholly synthetic example and instructions. The examples deliberately leave decisions open. Keep them separate from real business records.

Plan a launch

Use T01, the market-scoped launch organiser, when you need to collect the first product questions and allocate owners. There are separate Ireland/EU, Great Britain and Northern Ireland files. Select the destination before recording a role or evidence task. The correct authority route appears beside the market branch.

Use the blank version rather than editing the synthetic product into your business. A sample action is a demonstration of a field, not a finding about your product.

Organise product evidence

Use T02, the PIF review index, when the main problem is finding and linking documents. It separates file presence, completeness, product-version relevance and the specialist finding. Those distinctions help a reviewer identify what is missing without confusing a document upload with approval.

The HPRA PIF guidance and the GB product guidance are source starting points for the corresponding market. The template does not replace the applicable legal provisions or a product-specific review.

Review artwork

Use T04, the label review organiser, when you have an artwork revision to check. Keep one market file per review. Each row connects a question to the artwork panel, evidence reference and source provision. A proposed correction belongs in its own field, with the eventual review decision recorded separately.

The Ireland/EU route starts with HPRA labelling guidance. The GB and NI files have separate source starting points. Do not transfer a conclusion between the files solely because the label looks similar.

Record a manufacturing event

Use T05, the batch record organiser, to connect a specific manufacturing event to the master instructions, material lots, observations, deviations and release record. Its example contains unresolved gaps and a hold. It is not a manufacturing recipe or an approved GMP system.

Keep the record usable

Save the resource version when you start. Identify the person editing the real record and retain superseded versions under your own document-control procedure. Use a new revision when the task scope changes. If a question does not apply, record who made that decision and why, rather than deleting the row.

Only released resources appear as live downloads. Planned resources remain identified as future tasks. The immediate next step is to select one task, the actual market and the current product or artwork revision, then assign the first unresolved question.

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.

HPRA: Article 19 labelling guidance and durability evidence; exact current provisions and exceptions need specialist verification

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

Source type: Official guidance

Retrieval date is not the legal application date. The complete current legal text has not been specialist-verified.

Check the actual packaging, language, product type and current Annex III separately.

HPRA: Guide IA-G0048-3: production, finished products, deviations, change control and documentation, sections 4.6, 4.7, 4.12, 4.14 and 4.16

Ireland / EU · Version: Official directory and linked IA-G0048-3 PDF, dated 11 February 2026, retrieved 16 October 2026 · Retrieved: 2026-10-16 · Legal effective date: See the legal-date basis below

Source type: Official guidance

The guide publication date is not an Article 8 legal application date or a finding about the actual manufacturer.

The HPRA guide supplements the standard; neither the full ISO standard nor a product-specific manufacturing system was assessed.

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.