Review of Registration and Manufacturing Process for Veterinary Disinfectants
The APVMA is seeking comment on the current efficacy data requirements for registration of disinfectants for veterinary use and the process by which they are manufactured.
Input into guidelines for data requirements
The APVMA is reviewing its advice on efficacy data requirements for registration of disinfectants for veterinary use that make generic label claims. This action has been prompted by findings of poor levels of efficacy in several products of this type.
Your input is sought into the provisions of the Guideline for Data to Support Efficacy of Disinfectants for Veterinary Use (PDF, 342kb)
The guideline will apply to veterinary disinfectant products that are used on hard, non-porous, inanimate objects or surfaces to destroy a range of microorganisms. These products are used in situations where animals are housed, treated or maintained – such as veterinary surgeries, animal facilities, kennels and cages. The guideline does not cover products that are used on surfaces that come into contact with food, or used on animals.
The guideline will clarify the data requirements for establishment of efficacy for these products.
Input into the manufacturing process
After registration, it is important that products are manufactured in such a way that they continue to comply with their registered particulars, that there is batch-to-batch consistency and that product remains within its shelf life.
Your input is also sought on the consideration that veterinary disinfectant products:
- must be manufactured in a facility that complies with Good Manufacturing Practice
- must be date-controlled; that is, the label must contain an expiry date that is supported by stability data.
Alternatively, these products could be registered with a condition that they must continue to comply with the formulation specified in the application for registration.
Making a submission
Submissions on the registration and manufacturing process of veterinary disinfectants can be made until 5pm, Friday 25 June 2010 by email to email@example.com or by mail to:
Miss Charu Joshi
Product Evaluator, Veterinary Medicines Program
PO Box 6182
Kingston ACT 2604
Phone: 02 6210 4867
After this consultation, the APVMA will implement the guideline as amended following your input and associated changes, and will conduct a review of currently registered products against the new guideline.