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NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/
VICH Update |
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The VICH ((International Co-operation on Harmonisation of Registration requirements for Veterinary Medicinal Products) steering committee has agreed to adopt the following harmonised VICH Guidelines. New Zealand along with Australia has observer status at VICH and also takes an active part in a number of the working groups drafting guidelines.
Final guidelines (with implementation dates in brackets):
| GL6 | Ecotoxicity Phase 1: environmental impact
assessment for veterinary medicines (1 July 2001) |
| GL7 | Efficacy requirements for anthelmintics: overall
guidelines (1 May 2001) |
| GL8 | Stability testing for medicated premixes (1 May 2001) |
| GL9 | Good Clinical Practices (1 July 2001) |
| GL10 | Impurities in new veterinary drug substances (1 May 2001) |
| GL11 | Impurities in new veterinary medicinal products (1 May 2001) |
| GL12 | Efficacy requirements for anthelmintics:
specific recommendations for bovines (1 May 2001) |
| GL13 | Efficacy requirements for anthelmintics:
specific recommendations for ovines (1 May 2001) |
| GL14 | Efficacy requirements for anthelmintics:
specific recommendations for caprines (1 May 2001) |
| GL17 | Quality of biotechnological products in the
veterinary field: stability testing of biotechnological / biological products (1 July 2001) |
| GL18 | Impurities: residual solvents (1 July 2001) |
MAF proposes to apply these guidelines (as appropriate) in its standards and guidelines for the registration of veterinary medicines under the Animal Remedies Act and, in future, under the ACVM Act.
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New Zealand Food Safety Authority
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