THE MANUFACTURERS' LICENSING SCHEME

The APVMA has, in consultation with the veterinary chemical industry and the wider community, revised and subsequently determined Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles) 2007 and released an Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (PDF - 507KB).

These requirements commenced on 1 May 2007. All audits conducted from 1 May 2007 onwards will assess manufacturers for compliance with the new requirements.

Details of APVMA considerations, including the process of industry consultation are described in the Regulation Impact Statement (PDF - 100KB).

Key Documents
Manufacturers' Licensing Scheme (GMP) Introduction
Who needs to have a licence?
New manufacturers
Authorised GMP auditors
How often will audits be performed?
What is involved in having an audit?
How will licences be issued?
Non-official audits by GMP consultants
Licence conditions
Certification or licensing by other specified authorities
Criteria for refusing, cancelling or suspending a manufacturer's licence
Reconsideration and review of decisions
Fees and charges

Key Documents

Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles) 2007
Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (PDF - 507KB)
Application for a Licence to Manufacture Veterinary Chemical Products (KP80F01)
Licensed Australian Manufacturers of Veterinary Chemical Products (PDF - 314KB)
(See also APVMA Gazette for monthly updates)
APVMA-authorised Good Manufacturing Practice auditors (PDF -111KB)
Recall Guidelines (PDF -175KB)

GMP Audits

GMP Audit Procedure Work Instruction (KP80W05)
Pre-Audit Information Required (KP80F02)
Pre-Audit Notification Form (KP80F04)
GMP Audit Report (KP80F05) for reference only
GMP Audit Report Supplement – Annex 1 (KP80F27) for reference only
GMP Audit Report Supplement – Annex 2 (KP80F28) for reference only
GMP Audit Report Supplement – Annex 3 (KP80F29) for reference only
GMP Audit Report Supplement – Annex 4 (KP80F30) for reference only
GMP Audit Report Supplement – Annex 5 (KP80F31) for reference only
GMP Audit Report Supplement – Annex 6 (KP80F32) for reference only
Response to GMP Audit Report (KP80F26)
GMP Audit Checklist for Manufacturers (KP80F33)

MLS introduction

Users of veterinary chemical products expect them to be safe, effective and of a high quality. The best way to meet these expectations is to build quality into the product at the time of manufacture; and to do that products must be manufactured consistently, by a specified method, under adequate supervision and with effective quality control procedures- that is using Good Manufacturing Practices (GMP). Also under the Agricultural and Veterinary Chemicals Codes, the APVMA is required to license manufacturers of veterinary chemical products.

To that end the APVMA established the Manufacturers' Licensing Scheme (MLS), the objectives of which include:

to assure (give confidence in) the quality of veterinary chemical products manufactured and supplied in Australia, and
to facilitate exports of Australian made veterinary chemical products through international harmonisation and attestation of GMP compliance (as appropriate).

The essential GMP requirements applicable to the MLS are expressed in Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles) 2007 and are given practical effect through the The Australian Code of Good Manufacturing Practice for Veterinary Chemical Products(PDF - 507KB)

The legal jurisdiction of the MLS (die the ability to licence manufacturers) extends only to Australian based manufacturers. The APVMA cannot licence overseas-based manufacturers supplying to the Australian marketplace. For veterinary chemical products manufactured overseas the Registrant must, however, demonstrate that the product is manufactured to quality standards (die Codes of GMP) comparable to those applying to veterinary chemical products manufactured in Australia. To find out more, read about the Overseas GMP Scheme.

MLS Glossary - for definition of terms used in the MLS

Who needs to have a licence?

An APVMA manufacturers' licence is required by anyone engaged in any step of manufacture of a veterinary chemical product in Australia (section 121(4) of the Agricultural and Veterinary Chemicals Codes). This includes (but is not limited to):

formulation and blending
assembling
packaging
labelling
storage associated with the manufacturing process
sterilising and microbiological reduction
analysis and testing
releasing from manufacture for supply or sale

The MLS covers warehousing or storage of goods when they form part of the manufacturing process. However, it does not include wholesale dealing (from the manufacturing or other premises) and subsequent storage (once the product has been released for supply).

Toll contractors (contract manufacturers) are required to be licensed. Likewise, contractors (or sub-contractors) that perform a single step such as contract analysis and testing or packing and labelling are required to be licensed, unless those operations are conducted exclusively for another manufacturer and that manufacturer is prepared to accept GMP responsibility and include the contractor on their MLS licence (Regulation 59A of the Agricultural and Veterinary Chemicals Code Regulations). The only steps covered by this regulation are analysis and testing, and packaging and labelling.

Registrants who have products made by toll contractors but who themselves engage in any step of the manufacturing process (such as release for supply) must also be licensed, usually as a single-step manufacturer.

New manufacturers

A new manufacturer is defined as:

one operating from new premises not previously licensed, or
an existing manufacturer operating from premises which are not currently licensed for a particular category of product or step of manufacture.

Under the Agricultural and Veterinary Chemicals Codes, any new manufacturer needs to hold a licence before they can manufacture veterinary chemical products in Australia.

New manufacturers must lodge their Application for a Licence to Manufacture Veterinary Chemical Products (form KP80F1)

Authorised GMP auditors

Authorised GMP auditors (PDF - 286KB) have been authorised by the APVMA on the basis of their experience, qualifications and familiarity with The Agricultural and Veterinary Chemicals Manufacturing Principles and the veterinary code of GMP.

The auditors are not employed by the APVMA, nor do they work under contract to the APVMA. Auditing is done under a contractual arrangement between the auditor and the manufacturer, who pays the auditor directly.

The functions of the auditors are to:

undertake the audit of premises and all assets (die plant and equipment, processes and procedures, staff and documentation etc) involved in the manufacture of veterinary chemical products against the Manufacturing Principles and the code of GMP ;
prepare audit reports detailing the extent of GMP compliance of the manufacturer, identify non-conformances and make suggestions for corrective actions and other improvements; and
undertake verification audits (on-site inspections) or desk reviews of submitted documentation to confirm implementation of required corrective actions.

The APVMA will require and implement measures to ensure that auditors:

do not have any conflict of interest which could undermine the independence and integrity of the MLS; and
treat as confidential all company information supplied for audit or generated after audits.

The APVMA will also implement measures to ensure that manufacturers do not unduly influence the outcome of the audit.

To ensure consistency among auditors in the interpretation and application of the Manufacturing Principles and the Code of GMP, the APVMA would appreciate compliments or complaints about the quality of audits or suggestions for improvement. These should be forwarded to the APVMA's Manager, Quality Assurance or Program Manager, Quality Assurance and Compliance- see Contacts.

How often will audits be performed?

Full audits are conducted on a rolling audit program where the frequency of audit is determined on the enduring compliance risk of the manufacturer, but generally within a maximum period of 24 months. In determining the re-audit interval, the APVMA takes into account a number of risk factors including, the nature of the veterinary chemical products manufactured, recent changes to the scope of a manufacturing licence, the audit history of the manufacturer, the number and nature of recalls and adverse experience reports occurring since the last audit and any other relevant information.

What is involved in having an audit?

The audit process, including details of how to go about arranging an audit, is described in the APVMA's work instruction GMP Audit Procedure (KP80_W05).

How will licences be issued?

Based on the audit report the APVMA may:

issue a licence,
defer issuing a licence until the APVMA is satisfied that all non-conformances have been corrected,
grant an extension of time to allow the manufacturer to correct non conformances prior to re-audit,
refuse to issue a licence (in the case of a new applicant), or
suspend or cancel an existing licence.

Manufacturers (licence holders) are required to forward the signed original completed version of each audit report and associated documents, including a completed Response to GMP Audit form (KP80F26 – see Key Documents), to the APVMA within 25 working days of the completion date of every audit conducted by an APVMA-authorised GMP auditor. Where the audit conducted by an APVMA-authorised GMP auditor identifies critical non-conformances, the manufacturer must notify those to the APVMA within 3 working days of the completion date of the audit at which those non-conformances were identified.

Manufacturers are also required to implement all the corrective actions arising from audits within the timeframes agreed to or specified by the APVMA. They are also required to provide the APVMA-authorised GMP auditor with appropriate objective evidence to confirm the satisfactory completion and implementation of all corrective actions.

Where a manufacturer disagrees with an auditor's approach or findings, the manufacturer should raise any concerns with the APVMA. This may be done either through the appropriate comments section in the Response to GMP Audit form or by separate correspondence. The APVMA will investigate and where necessary arbitrate on issues in dispute. It is important to appreciate that it is the manufacturer rather than the auditor, who is ultimately responsible for determining the most appropriate corrective actions required to address non-conformances and to satisfy the APVMA that they are adequate, appropriate and implemented.

If a licence is to be issued, the manufacturer will be notified and invoiced for the relevant licence fee. Once the fee has been paid, a licence will be generated and posted to the manufacturer.

Where the APVMA agrees to grant an extension of time to allow the manufacturer to correct deficiencies prior to re-audit, the manufacturer will be expected to make the necessary progress towards compliance within the time agreed.

Unofficial audits by GMP consultants

Manufactures may if they wish, engage APVMA-authorised GMP auditors, or any other suitably qualified consultant, to audit their plant at any time to:

assess the current level of compliance, and
provide advice on and assistance in meeting the Codes of GMP.

However, auditing for licensing purposes can only be carried out by APVMA-authorised GMP auditors. An auditor cannot perform this task if he or she has been engaged by the manufacturer on GMP related consulting matters (other than for licensing / auditing purposes) in the previous two years.

Licence conditions

Once a licence is issued it will remain in force unless suspended or cancelled. The licence is subject to the conditions under section 126 of the Agricultural and Veterinary Chemicals Codes and Regulation 61 of the Agricultural and Veterinary Chemicals Code Regulations plus any other conditions articulated in the licence and any schedules to the licence.

Any changes to the licence must be notified to the Manager, Quality Assurance -see Contacts.

The Manager, Quality Assurance will advise what conditions must be satisfied for continued manufacture under the licence. As a general guide:

Where an existing manufacturer proposes to extend its category of manufacture to any category lower than the existing category (e.g. from Category 2 to Category 2 and Category 4), the APVMA, at its discretion, may permit this on notification, but subject to satisfactory audit outcomes, either at the next scheduled routine audit or within 12 months, which ever is the earlier date. However, the application to amend the existing licence must be made prior to the start of manufacture.
Where a manufacturer wishes to upgrade a facility to a category of manufacture higher than the existing category (e.g. from Category 4 to Category 4 and/or Category 2), an application for a new licence will need to be made and a satisfactory audit conducted on the new part of the manufacturing premises before the new licence is issued and start of Category 2 manufacture.
Where an existing Category 1,2, 3 or 4 manufacturer wishes to extend product dosage forms within its existing category of manufacture, the APVMA may, depending on the nature of the dosage form and assessed compliance risk, amend the licence without requiring an audit. The application to amend the existing licence must be made and the licence amended prior to the start of manufacture.

Certification or licensing by other specified authorities

The APVMA will recognise certification or licensing from the Therapeutic Goods Administration (TGA), National Association of Testing Authorities (NATA) as evidence of compliance with the Manufacturing Principles and code of GMP. That recognition is given, provided that the manufacturer has been audited specifically to establish compliance of manufacture of the veterinary chemical product produced on the premises against a comparable GMP Code as determined by the APVMA. ISO Quality Management System Standards are not considered comparable to the applicable GMP Codes.

Criteria for refusing, cancelling or suspending a manufacturer's licence

The reasons for refusing, cancelling or suspending a manufacturer's licence are listed in Sections 124 and 127 of the Agricultural and Veterinary Chemicals Codes and includes the contravention of licence condition(s) and the non-payment of prescribed fees.

Reconsideration and review of decisions

Under section 166 of the Agricultural and Veterinary Chemicals Codes, manufacturers may apply to the APVMA or a reconsideration of a decision made by the APVMA under:

part 8 of the Agricultural and Veterinary Chemicals Codes to refuse an application for a licence,
part 8 of the Agricultural and Veterinary Chemicals Codes to issue a licence subject to particular conditions referred to in subsection 126(1),
subsection 126(2) of the Agricultural and Veterinary Chemicals Codes to impose a new condition on a licence or varying an existing condition, or
section 127 of the Agricultural and Veterinary Chemicals Codes to suspend or cancel a licence.

Upon receipt of a request for a reconsideration, the APVMA is obliged to reconsider its original decision, and either confirm, vary or set aside the original decision and make a new decision in substitution for the original decision. The decision on the reconsideration is taken to be a fresh decision and so must be made by a person other than the person who made the original decision. Seeking such reconsideration does not affect manufacturers' rights to apply to the Administrative Appeals Tribunal (AAT) for review of the decision of the APVMA in relation to the matters listed above. Applications for a reconsideration should be made in writing to the:

General Counsel, Legal Group
APVMA
PO Box 6182
KINGSTON ACT 2604
AUSTRALIA

Manufacturers may also raise any concerns they have regarding any aspects of the MLS with the Manager, Quality Assurance or Program Manager Quality Assurance and Compliance (see Contacts) or through the MLS Industry Liaison Committee. The committee was established to provide an opportunity for the APVMA to discuss with industry representatives strategic and operational issues relating to the MLS. Membership details of the committee can be found on Committees page.

Fees and charges

Licence fees are prescribed in Regulation 72A of the Agricultural and Veterinary Chemicals Code Regulations.

Audit charges vary depending on the duration of the audit, the complexity of the manufacturing premises and category of manufacture, and the extent of travel required. The auditor determines the audit charges; the APVMA has no say in the setting of those charges.