1. 1969
2. World Health Organization http://apps.who.int/ medicinedocs/en/d/Js4893e/3.html
3. Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Article 29A;Official J,1975
4. Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (text with EEA relevance);Official J,2000
5. Pharmacovigilance