11 November 2019

VICH

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

VICH is a trilateral (EU-Japan-USA) programme with the objective to harmonise technical requirements for the data necessary for the marketing authorisation (also called registration) of a veterinary medicinal product.

VICH sets standards for scientific studies to generate data on quality, safety and efficacy, necessary for registration of veterinary medicines.

Australia has an observer status on VICH, along with Canada, New Zealand and South Africa.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted VICH guidelines on data requirements for chemistry, human safety (toxicology), environmental safety, anthelmintics and good clinical practices.

global context