This file may not be suitable for users of assistive technology.
Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email firstname.lastname@example.org. Please tell us what format you need. It will help us if you say what assistive technology you use.
The guidance covers the role of the regulatory decision-maker in the National Business Unit, who has responsibility for reviewing the information provided, and the inspector, who may be asked to pursue particular issues relating to suitability during a visit.