Gazette APVMA 2, 1 February 2005 page 22

NOTICE
The Reconsideration of Veterinary Chemical Product Registrations relating to assuring the GMP compliance of overseas manufacturers of veterinary chemical products

The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, intends to reconsider the approvals of all registrations of veterinary chemical products that are manufactured overseas. This activity is part of the APVMA’s initiative to ensure the ongoing quality of all veterinary chemical products. The purpose of the reconsideration is to apply new conditions to all veterinary chemical product registrations that involve overseas manufacturers.

The conditions are described below. It is expected that the proposed conditions would formalise requirements that most registrants would already be observing as part of company quality assurance programs. Letters will be sent to all affected registrants, inviting them to make a submission if desired.

Conditions of Product Registration

The conditions will state that:

a) The Registrant must not supply the chemical product, or cause it to be supplied, unless the chemical product has been manufactured according to the NRA/APVMA Manufacturing Principles and associated Codes of GMP, or those of a Recognised Authority deemed to be equivalent by the APVMA.

b) The Registrant must, at or prior to the supply of a batch of the chemical product by the Registrant or by another person on behalf of the Registrant, make or have in its possession, a record that the chemical product has been manufactured according to the NRA/APVMA Manufacturing Principles and associated Codes of GMP, or those of a Recognised Authority deemed to be equivalent by the APVMA.

c) The Registrant must produce, or cause to be produced, to the APVMA any record within 10 working days of the request having been made by the APVMA, or other such period as determined by the APVMA.

d) The Registrant must keep, or cause to be kept, any record for one year after the expiry date of any batch that is made.

e) For the purposes of these conditions, records are in the possession of the Registrant if records are:

a. in the possession of the Registrant; or
b. in the possession of another person pursuant to an arrangement with the Registrant.

For further information or to make a submission for this review, contact:

Dr Toni Pike
Quality Assurance Reviewer
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
Kingston ACT 2604
Phone: (02) 6272 4408
Fax: (02) 6271 6442
Email: toni.pike@apvma.gov.au

Submissions must reach the APVMA by 31 March 2005.