The Decree sets out the terms and conditions of the medical inspection carried out by the Universal Health Insurance management body.
The law adopts the Code of Administrative Procedure. The Code establishes the principles and rules to be observed in the exercise of administrative activity, aimed at achieving the public interest, while respecting the subjective rights and legally protected interests of individuals and legal persons.
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.
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.