APVMA’s new procedures for assuring the GMP compliance of overseas manufacturers of veterinary chemical products
(‘Overseas GMP scheme’)

Questions & Answers – February 2005

1. Where can I find details of the new scheme? (February 2005)

The new scheme is described in the notice, Introduction of new procedures to assure the ongoing GMP compliance of overseas manufacturers of veterinary chemical product, published in the APVMA Gazette dated 1 February 2005.

2. Are all veterinary chemical products affected? (February 2005)

No. Only veterinary chemical products that have overseas manufacturers are affected by the new scheme.

3. What costs and timeframes are involved? (February 2005)

Currently, the APVMA does not charge a direct fee for administering the new scheme. The costs to registrants will be those of maintaining current evidence of GMP compliance and the administrative cost of submitting this evidence to the APVMA when it is requested. The cost of maintaining current evidence will be variable, ranging from obtaining a current certificate to funding an overseas audit.

4. What happens to my existing registered product? (February 2005)

All the existing registered veterinary chemical products that have overseas manufacturers will be subject to a Reconsideration. The purpose of this Reconsideration will be to add conditions of registration to assure the enduring GMP compliance of overseas manufacturers. Registrants of these products should receive a letter from the APVMA shortly after February 17 2005.

5. What happens to my application currently before the APVMA? (February 2005)

Any applications before the APVMA on February 17 2005 will have new conditions of registration added if they relate to:
a) registration of new veterinary chemical products that are manufactured overseas; or
b) approval of a new overseas manufacturer.
The conditions of product registration will automatically be applied to relevant product registrations where the applications are received subsequent to February 17, 2005.

6. What type of records do I need to maintain to comply with the conditions of product registration? (February 2005)

To comply with the conditions of registration, registrants must maintain satisfactory evidence of the GMP compliance of each overseas manufacturer. The type of evidence required is identical to the type of evidence accepted by the APVMA for product registration. For more details, please see Question 11.

7. How often will the APVMA be auditing records? (February 2005)

Generally speaking, the APVMA will ask a registrant to submit evidence to the Quality Assurance and Compliance Program at intervals of approximately three years. This evidence will be audited.

8. Will the APVMA be auditing evidence on an individual product basis, or by company or by manufacturing site? (February 2005)

Essentially, evidence will be audited on the basis of individual products. However, where practical, evidence will be requested on the basis of groups of related products or a manufacturing site.

9. When evidence is requested, what will the timeframe be for its submission? (February 2005)

Registrants will be asked to submit evidence within three weeks from the date of the letter of request. The onus is on registrants to maintain current evidence of GMP compliance, and it is not satisfactory to wait until evidence is requested by the APVMA before obtaining evidence.

10. What will happen if the submitted evidence is not satisfactory? (February 2005)

If the evidence is not satisfactory, the APVMA will request the submission of more appropriate evidence. If a registrant is unable to supply satisfactory evidence of current GMP compliance, then the registration may be suspended or cancelled due to the breach of conditions of product registration.

11. What evidence of GMP compliance is acceptable to the APVMA? (February 2005)

Acceptable evidence is considered to be as detailed in the table Guidelines for Providing Evidence of GMP status of Overseas Manufacturers. The comments below are generalisations, which do not apply to all product types.

In general, acceptable evidence is considered to be as follows:

a) Where manufacture occurs in a country with which Australia has a Mutual Recognition Agreement on Conformity Assessment with respect to veterinary chemical products, the evidence required is a current and acceptable Certificate of GMP Compliance of a Manufacturer from the relevant competent authority (see EU-Australia MRA List of Competent Authorities).

b) Where manufacture occurs in another country whose GMP program is recognised by the APVMA, eg USA, NZ and Canada, or countries whose competent authority (ie the agency responsible for issuing manufacturing licences or authorisations) is a member of the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), the evidence required is a current and acceptable certificate of GMP compliance or an audit report from a Recognised Authority.

c) Where manufacture occurs in a country with which Australia does not have a Mutual Recognition Agreement (MRA) or whose GMP program is not recognised by the APVMA, the acceptable evidence of GMP compliance might include:

i) a current and acceptable certificate of GMP from a Recognised Authority, which is based on a satisfactory audit by them.

ii) a satisfactory audit report by an auditor from a Recognised Authority, confirming that the premises complies with a GMP Code recognised by the APVMA as comparable to the relevant Australian GMP Code.

iii) a satisfactory audit report by an Australian APVMA-authorised GMP auditor, confirming that the premises complies with the Australian Code of GMP. All fees incurred for such an audit are to be met by the Registrant or overseas manufacturer.

In order to establish what objective evidence is required in such instances, registrants are advised to contact the APVMA’s Quality Assurance and Compliance Program well before lodging an application for product registration.

12. Where can I obtain further information about the scheme? (February 2005)

From time to time, new information may be released about the scheme. Further information can be obtained from the APVMA website, or by contacting:

Dr Toni Pike
Quality Assurance Reviewer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Phone: (02) 6272 4408
Fax: (02) 6271 6442
Email: toni.pike@apvma.gov.au