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Gazette APVMA 1, 2 January 2007 - page 8
NOTICE
Adoption of VICH guidelines GL 36 and GL 37
A program aimed at harmonising technical requirements for veterinary product registration was launched in Paris in April 1996, as a cooperative effort between members of the regulatory authorities and the veterinary chemical industry from the European Union, USA, and Japan. The program is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, known as VICH.
The APVMA and New Zealand’s Agricultural compounds and Veterinary Medicines Group (ACVM) have observer status on the VICH Steering Committee.
VICH has finalised two new guidelines:
VICH GL36: Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
VICH GL37: Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose chronic toxicity testing
The full text of the guidelines may be seen on the VICH website at http://www.vichsec.org/htm/guidelines.htm
The APVMA published on its website, its proposal to adopt these two VICH guidelines and has not received adverse comment on this proposal.
The APVMA has now adopted these two VICH guidelines. The guidelines may assist applicants to comply with toxicology data requirements (data Part 3) and should be read in conjunction with those requirements.
The APVMA’s data requirements may be seen in the Manual of Requirements and Guidelines (MORAG) on the APVMA website: http://www.apvma.gov.au/MORAG_vet/MORAG_vet_home.shtml.
For further information, contact:
Martin Holmes
Program Manager, Veterinary Medicines
Australian Pesticides and Veterinary Medicines Authority
PO Box 240
KINGSTON ACT 2604
Phone: (02) 6210 4725
Fax: (02) 6210 4741
email martin.holmes@apvma.gov.au