Appointing or changing a cosmetic Responsible Person

Make the proposed role change traceable

Start with the exact product set, recorded market, current role evidence and proposed new arrangement. Identify what is changing: the entity, its address, an administrative contact, access to records or the supply activity. These are different facts and should not be compressed into a new contact name in a spreadsheet.

The HPRA role guidance is the Ireland/EU starting point. Article 4 of the current EU consolidation describes particular role and designation circumstances, including written mandate and acceptance provisions. The reviewer must establish which circumstance applies; this organiser is not an appointment contract or a determination that a proposed entity qualifies.

Record the actual scope

List the product identifiers and revisions, relevant destinations, business activities and the proposed effective arrangement. Keep a target handover date separate from the specialist's legal-date finding. Do not infer the applicable establishment requirement from a country abbreviation in a mailing address.

The GB guidance and NI scope require separate review. A service agreement covering one destination should not silently become the evidence for all markets.

Build the handover index

The blank organiser records the existing and proposed role references, the legal basis to verify, acceptance evidence where applicable, product-file access, assessment and artwork references, notification questions, unresolved actions and owners. Use actual document versions and retain the earlier arrangement.

For each topic, distinguish evidence located, completeness checked and specialist finding. A new party receiving a folder does not by itself establish a valid appointment or resolve the duties attached to the role.

Synthetic cream: a proposal with missing acceptance evidence

Fictional SAMPLE-CREAM, revision 3, has a proposed change from Example Entity A to Example Entity B for an Ireland/EU scope. No actual entity, address, signed mandate, acceptance or role decision is supplied. The example records those absences explicitly.

One sample owner must obtain the proposed scope and role evidence. Another task concerns the product-file access arrangements. The notification and artwork implications remain questions for the appropriate reviewer. No real appointment is made and no portal update is performed by completing the example.

Check the records that depend on the decision

Once a real scoped decision is recorded, identify which associated records require action. Do not rewrite old artwork or notification history to make it appear that the new arrangement always applied. Retain the earlier product and role references and the date basis used for the actual change.

Verify that the agreed recipient can access the controlled product information and unresolved actions. Record who checked access and what remained unavailable. Coordinate confidentiality and retention arrangements with the responsible owner instead of using a public folder link as a substitute for a handover.

The roles hub provides the released next tasks. Finish with a documented question or decision, its product and market scope, evidence versions and accountable owners. The administrative organiser supports that review; it does not replace the legal role analysis or either party's actual acceptance.

Sources and legal dates