Guidance

Guidelines for submitting a dermatological product to the ACBS

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

• From: Department of Health and Social Care
• Published: 12 April 2019

Documents

Appendix 1: categorisation of dermatological products

PDF, 145 KB, 1 page

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Appendix 2: types of application

PDF, 59.3 KB, 2 pages

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Appendix 2.1: evidence required for type 3 applications

PDF, 126 KB, 3 pages

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Appendix 3: cosmetic legislation and other guidance

PDF, 12.1 KB, 2 pages

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Appendix 4: clinical trial information to be provided for type 1 (new products)

PDF, 10.8 KB, 2 pages

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Appendix 5: The mechanism for ensuring that patients are protected

PDF, 105 KB, 2 pages

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Details

This set of documents contains supporting information for use in submitting a dermatological product for consideration by the Advisory Committee for Borderline Substances (ACBS).

This includes:

• the mechanism for ensuring patient safety
• products that will not be considered
• clinical trial information be applied for type 1 products

The documents can be used when filling out the dermatological products application form.

Published 12 April 2019