180 Postmarketing reporting of adverse experiences[ R].The Code of Federal Regulations, FDA, USA, 21CFR600.80Sec.600
2Current Problems in Pharmacovigilance Committee on Safety of Medicines [R], Medicines Control Agency, UK
3Medicine Problem Report [ R], Therapeutic Goods Administration, Australia
480 Postmarketing reporting of adverse drug experiences[R].The Code of Federal Regulations, FDA, USA,21CFR314.80 Sec.314
5305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications[R].The Code of Federal Regulations, FDA, USA,21CFR310.305 Sec.310
6Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) [R] , VICH GL29, USA
7Guidance for Industry, Postmarketing Safety Reporting for Human Drug and Biological, Products Including Vaccines[R].FDA, USA
8Principles of Providing the World Health Organization with Pharmacovigilance Information, Human Medicine Evaluation Unit [R], the European Agency for the Evaluation of Medicinal Products
9Conduct Pharmacoviggilance for Centrally Authorised Products, Human Medicine Evaluation Unit [R], the European Agency for the Evaluation of Medicinal Products
10VOLUME 9 PHARMACOVIGILANCE, Medicinal Products for Human and Veterinary Use [R], the European Agency for the Evaluation of Medicinal Products
