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.

Updates to this page

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

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

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

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

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

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

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

  7. 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. First published.

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