# Guidelines for submitting a nutritional product to the ACBS

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c94ff97f-235a-499b-8fd4-d6cf3e641fc2
Type: Guidance
Published: April 11, 2019
Updated: February 1, 2024

> The document provides comprehensive guidance for the submission of nutritional products to the UK Advisory Committee for Borderline Substances (ACBS). This regulatory framework establishes the standards for manufacturers seeking to have their products recognized for clinical use. The guidance details how nutritional products are categorized by the ACBS and specifies the clinical and nutritional evidence required for a successful application. While the provided text does not reference a specific company, inspection dates, or violations—as it is a general guidance document rather than an inspection report—it mandates that all applicants follow relevant nutritional legislation and procedural requirements. The required actions for manufacturers include reviewing the categorization criteria, gathering necessary supporting evidence, and utilizing these resources to accurately complete the formal nutritional products application form. This ensures that all products undergo a rigorous assessment based on established legislative standards and clinical necessity before being approved for use within the designated healthcare framework.

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## Content

This set of documents contains supporting information for use in submitting a nutritional product for consideration by the Advisory Committee for Borderline Substances ( ACBS ). This includes: how nutritional products are categorised by the ACBS evidence required for applications relevant nutritional legislation The documents can be used when filling out the nutritional products application form .

## Attachments

- [Guidance notes for completing an application form for a nutritional product](https://assets.publishing.service.gov.uk/media/64831e005f7bb7000c7fa7b1/guidance-notes-for-completing-an-application-form-for-a-nutritional-product-june-2023.docx)
- [Appendix 1: categorisation of nutritional products](https://assets.publishing.service.gov.uk/media/5ca622e7e5274a77dea4234b/Appendix1.pdf)
- [Appendix 2: types of application](https://assets.publishing.service.gov.uk/media/62723fefd3bf7f0e7a064a9c/Appendix-2-type-of-nutritional-application.pdf)
- [Appendix 3: nutritional legislation](https://assets.publishing.service.gov.uk/media/5ca6231fed915d0c47666faa/Appendix3.pdf)
- [Appendix 4: clinical trial information to be applied for type 1 products](https://assets.publishing.service.gov.uk/media/5ca6233ce5274a77da137eee/Appendix4.pdf)
- [Appendix 5: acceptability studies](https://assets.publishing.service.gov.uk/media/6454d922faf4aa0012e133b6/Appendix5-may-2023-final.pdf)
- [Appendix 6: products which will not be considered](https://assets.publishing.service.gov.uk/media/5ca62376e5274a77d2bf93ba/Appendix6.pdf)
- [Appendix 7: the mechanism to ensure patients will be protected](https://assets.publishing.service.gov.uk/media/5ca6239540f0b625e347d13e/Appendix7.pdf)
- [Appendix 8: the scheduling of product applications to an ACBS meeting agenda](https://assets.publishing.service.gov.uk/media/637cd3ebe90e076b82b8cce2/Appendix8.pdf)