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 law establishes the obligation to affiliate to the "Caisse Nationale de Solidarité et de Prévoyance Sociale" for any employer who employs one or more workers, as well as the public administration in its quality of employer.
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.
The Code provides for the "Caisse Nationale de Prévoyance Sociale" (CNPS) whose tasked is to provide benefits to salaried employees to alleviate the financial consequences of certain risks or situations such as accident at work and occupational diseases, maternity, retirement, invalidity and death and family allowances (art. 1 and 5).
Decreto-Lei No 5/86
The Decree defines the basis for the Workers' Social Security system