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).
Applies to England
Documents
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
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Removed 'Appendix 2.1: evidence required for type 3 applications' because this document no longer applies.
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In section 2.4 of 'Guidance notes for completing an application form for a nutritional product' the MHRA email address has been amended.
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Appendix 5 has been updated with new guidance on acceptability studies for inherited metabolic disorders.
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Added appendix 8: the scheduling of product applications to an ACBS meeting agenda
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Added guidance notes for completing an application form for a nutritional product.
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Updated the definitions for type 2 and type 3 applications, in the attachment 'Appendix 2: types of application'.
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Updated to remove the requirement to submit a type 3 application for changes to (i) a product鈥檚 shelf life and (ii) the location of manufacture.
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First published.