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.
The Environmental Management Act
This Act provides for a legal and institutional framework for sustainable management of the environment; outlines principles for management, impact and risk assessments, prevention and control of pollution, waste management, environmental quality standards, public participation, compliance and enforcement; provides for implementation of international instruments on environment; provides for implementation of the National Environment Policy; repeals the National Environment Management Act, 1983; provides for the National Environment Management Council and the National Environmental Trust Fund.
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.