Legislation

Legislation

EUROPEAN

Directive 2010/84/EU;
Regulation 1235/2010;
Good Pharmacovigilance Practices Module VI: Management and Reporting of Adverse Reactions to Medicinal Products (Rev. 2)

NATIONAL

Decree of Law No. 176/2006 of 30 August amended by Decree Law 20/2013 of 14 February.