International Guidelines

VICH LogoOne may assume VICH to be an acronym – it isn’t.  Its full title is the ‘International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products’.

The role of VICH is to harmonise technical requirements for data necessary for the registration of a veterinary medicinal product.  This is achieved by developing harmonised guidelines on the studies to be submitted in a marketing authorisation application.  Typically a VICH guideline describes how a study should be conducted to satisfy quality, safety or efficacy data requirements.  VICH also covers data requirements for post-marketing pharmacovigilance systems.

The majority of AMA’s members have a global presence and therefore have products registered all over the world; it is therefore important to have VICH guidelines to avoid studies being duplicated or repeated in each country where the products exist.  The regulatory environment in Australia is slightly different to other parts of the world due to the variation of climatic conditions from one end of the country to the other.  Because of these variations, products may have additional regulatory requirements and protocols to meet.  While applying VICH guidelines to the application process is critical, it is an important role for APVMA to maintain specific guidelines for Australia alone.

Please refer to the link below to further understand the scope of VICH guidelines, otherwise this information can be found in word form on the VICH website

VICH Guidelines Chart