Gazette APVMA 2, 1 February 2005

NOTICE

Introduction of new procedures to assure the ongoing GMP compliance of overseas manufacturers of veterinary chemical products.

New arrangements to assure the ongoing GMP compliance of overseas manufacturers of veterinary chemicals were proposed in the draft (Consultation) Regulation Impact Statement that was published in September 2004.

Consultation included meetings with, and submissions from, industry. The final Regulatory Impact Statement was approved by the Office of Regulation Review and can be found on the APVMA website, www.apvma.gov.au.

Three procedures will be implemented from 17 February 2005, namely:

a) Consideration of applications before the APVMA;

b) Re-consideration of existing veterinary chemical products; and

c) Auditing of evidence of enduring GMP compliance of overseas manufacturers.

Consideration of applications before the APVMA

The implementation date for the initial stage of these arrangements will be Thursday, 17 February 2005. After that date, all current veterinary chemical product applications will have the relevant conditions of registration (see below) added if they relate to:

a) registration of new veterinary chemical products that are manufactured overseas; or

b) approval of a new overseas manufacturer.

As of 17 February 2005, the APVMA will write to all applicants of current relevant applications to inform them of the new conditions that will be imposed on their product registration.
Conditions of product registration will also be imposed on relevant product registrations resulting from new applications received after 17 February 2005.

Consideration of existing veterinary chemical products
All currently registered veterinary chemical products manufactured overseas will be reconsidered, in accordance with Part 2 Division 4 of the Agvet Codes. Please refer to the separate notice in this gazette.

Auditing of evidence of enduring GMP compliance of overseas manufacturers

After the conditions are added to the product registration details, the registrant will be required to maintain current evidence of GMP compliance. From time to time, particularly as the most recent evidence seen by the APVMA expires, the APVMA will request that current evidence be submitted directly to the Quality Assurance and Compliance Program. Failure to satisfy the APVMA of GMP compliance will be a breach of the conditions of product registration and further action will be taken.

Guidelines

The type of record that is to be provided as evidence of GMP compliance is the same as that required as evidence of GMP compliance for product registration. Please see the updated Guidelines for demonstrating the GMP status of overseas manufacturers of veterinary chemical products, on the APVMA website, .http://www.apvma.gov.au/qa/gmp_status.pdf

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:

i) in the possession of the Registrant; or
ii) in the possession of another person pursuant to an arrangement with the Registrant.

For further information, 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