Module 4 - Safety


A. Antimicrobial resistance

a) VICH GL27 and registration of antimicrobials (VOF 13, November 2020)

b) VICH GL27 and registration of antimicrobials (ASEAN Training on VICH, 26-27 April 2017, Brunei)

  • VICH GL27: Guidance on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food Producing Animals with Respect to Antimicrobial Resistance (April 2017)
  • Brief Introduction for Approval System of Antimicrobials in Japan (April 2017)

B. Residues and consumer safety

C. Environmental Safety Assessment

  • The VICH guidelines on Environmental Risk Assessment of Veterinary Medicines - VICH GL6 and GL38 (VOF 14, November 2021)
  • The implementation of VICH GL6 and GL38 in Evaluating the Environmental Impact of Animal Drugs

a. in the EU
b. in the USA
c. in Japan