The document is a comprehensive Regulation on data protection in Nigeria. It is a guide to assist data controllers and data administrators/processors in understanding the controls and measures they need to introduce into their operations in order to comply with the Nigeria Data Protection Regulation.
These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.