Guidance

Guidelines for submitting a nutritional product to the ACBS

Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).

• From: Department of Health and Social Care
• Published: 12 April 2019
• Last updated: 1 February 2024 — See all updates

Applies to England

Documents

Guidance notes for completing an application form for a nutritional product

MS Word Document, 117 KB

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Appendix 1: categorisation of nutritional products

PDF, 199 KB, 5 pages

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Appendix 2: types of application

PDF, 127 KB, 3 pages

Appendix 3: nutritional legislation

PDF, 160 KB, 5 pages

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Appendix 4: clinical trial information to be applied for type 1 products

PDF, 157 KB, 3 pages

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Appendix 5: acceptability studies

PDF, 91.8 KB, 6 pages

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Appendix 6: products which will not be considered

PDF, 89 KB, 4 pages

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Appendix 7: the mechanism to ensure patients will be protected

PDF, 137 KB, 2 pages

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Appendix 8: the scheduling of product applications to an ACBS meeting agenda

PDF, 56 KB, 2 pages

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Details

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.

Published 12 April 2019
Last updated 1 February 2024 + show all updates

1. 1 February 2024

   Removed 'Appendix 2.1: evidence required for type 3 applications' because this document no longer applies.

2. 9 June 2023

   In section 2.4 of 'Guidance notes for completing an application form for a nutritional product' the MHRA email address has been amended.

3. 5 May 2023

   Appendix 5 has been updated with new guidance on acceptability studies for inherited metabolic disorders.

4. 21 November 2022

   Added appendix 8: the scheduling of product applications to an ACBS meeting agenda

5. 17 November 2022

   Added guidance notes for completing an application form for a nutritional product.

6. 4 May 2022

   Updated the definitions for type 2 and type 3 applications, in the attachment 'Appendix 2: types of application'.

7. 4 February 2022

   Updated to remove the requirement to submit a type 3 application for changes to (i) a product’s shelf life and (ii) the location of manufacture.

8. 12 April 2019

   First published.