# Guidelines for submitting a dermatological product to the ACBS

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d958dfe3-3b7a-4442-ac9a-5b10923843d3
Type: Guidance
Published: April 12, 2019

> The provided documentation outlines the regulatory framework and procedural requirements for submitting dermatological products to the UK Advisory Committee for Borderline Substances (ACBS). This guidance serves as a resource for applicants to ensure their products meet safety standards and are correctly categorized during the evaluation process. Specifically, the documents clarify the mechanisms for ensuring patient safety and identify the criteria for Type 1 products, which are identified as items that may not require full clinical trial information. Although the source text does not specify a particular company name, inspection dates, or violations—as it is a general guidance document rather than an inspection report—it establishes clear regulatory expectations for product consideration. The framework requires applicants to utilize the provided information to complete dermatological product application forms with precision. Required actions for manufacturers include demonstrating safety protocols and adhering to the ACBS classification system to facilitate the review of substances that exist on the boundary between medicines and other categories. By following these guidelines, applicants ensure their submissions are robust and aligned with UK standards for borderline dermatological treatments.

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## Content

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 .

## Attachments

- [Appendix 3: cosmetic legislation and other guidance](https://assets.publishing.service.gov.uk/media/5ca6262d40f0b625dd1ce1b5/Appendix-3.pdf)
- [Appendix 1: categorisation of dermatological products](https://assets.publishing.service.gov.uk/media/5ca625f2ed915d0c57e97ec7/Appendix-1.pdf)
- [Appendix 2: types of application](https://assets.publishing.service.gov.uk/media/5ca62604ed915d0c52f334f6/Appendix-2.pdf)
- [Appendix 2.1: evidence required for type 3 applications](https://assets.publishing.service.gov.uk/media/5ca62619ed915d0c55c71f50/Appendix-2-1.pdf)
- [Appendix 4: clinical trial information to be provided for type 1 (new products)](https://assets.publishing.service.gov.uk/media/5ca6263fed915d0c52f334f7/Appendix-4.pdf)
- [Appendix 5: The mechanism for ensuring that patients are protected](https://assets.publishing.service.gov.uk/media/5ca62653e5274a77d9d27052/Appendix-5.pdf)