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).

Documents

Appendix 1: categorisation of dermatological products

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Appendix 2: types of application

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Appendix 2.1: evidence required for type 3 applications

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Appendix 3: cosmetic legislation and other guidance

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

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Appendix 5: The mechanism for ensuring that patients are protected

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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