Product category and market
State the actual legal category and supply market of the product. Assessment follows the dietary-management use described in the application. An award does not establish the product’s legal classification or authorise its supply.
- Give the classification used in the stated market and supporting information.
- Identify the formulation, presentation and label version.
- Describe the intended clinical context and conditions of use.
The nutritional need
Explain the particular nutritional requirement and why ordinary dietary modification does not adequately meet it in the intended context.
- Identify the population and the dietary-management need.
- State whether the product provides complete nutrition or supplements other intake.
- Describe the intended amount, preparation and route of use.
- Provide the actual medical-supervision instructions and relevant exclusions.
Clinical and composition evidence
Present composition, suitability and relevant clinical evidence together. Explain how the studied population and formulation relate to the intended users and submitted product.
| Evidence | What reviewers need to understand |
|---|---|
| Composition | Amounts, units, sources and the basis for the proposed nutritional role. |
| Clinical relevance | The population, use, outcomes and limitations of the supporting evidence. |
| Practical use | Preparation, administration, supervision and relevant contraindications. |
| Quality and safety | Existing reports, dates, batch or specification scope, stability and relevant concerns. |
Specialist assessment
The category review covers clinical nutrition and the subject of the application, together with the market classification and proposed public award statement.
Submit the clinical information with the common evidence documents. The ordinary-food category does not replace these requirements. Requests for clarification are made through the application so that the questions and answers remain part of the assessment.
Public records and mark use
The public statement, certificate and proposed mark use must fit the requirements of the stated market. Recognition concerns the assessed nutritional use and must not be presented as a treatment claim.
The category check includes whether an appropriate public verification record can be provided. If the proposed scope cannot support such a record, that scope cannot proceed. Packaging and other proposed uses receive a separate artwork check.