Products Manufactured in Australia

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 outlined in:

The legal jurisdiction of the MLS (ie. the ability to license manufacturers) extends only to Australian based manufacturers. The APVMA cannot license overseas-based manufacturers supplying to the Australian marketplace.

For veterinary chemical products manufactured overseas, the registrant must demonstrate that the product is manufactured to quality standards (ie. Codes of GMP) comparable to those applying to veterinary chemical products manufactured in Australia. Please refer to the Overseas GMP Scheme for further information on products manufactured overseas.

Key Documents and forms

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Who needs to have a license?

An APVMA manufacturers' license 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):

  • quality assurance (QA) of raw materials (and/or packaging materials)
  • formulation and blending
  • assembling
  • packaging
  • labeling
  • 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 labeling 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 license (Regulation 59A of the Agricultural and Veterinary Chemicals Code Regulations). The only steps covered by this regulation are analysis and testing, and packaging and labeling

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.

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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 license before they can manufacture veterinary chemical products in Australia.

New manufacturers must lodge their Application for a license to Manufacture Veterinary Chemical Products (form KP80F01) (DOC, 177kb),

The APVMA will advise the applicant if a GMP audit of the premises is required.

Please note:  applicants must apply for and obtain a licence from the APVMA prior to the commencement of any step of manufacture of veterinary chemical products.

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APVMA-Authorised GMP Auditors

The APVMA has authorised GMP auditors (PDF, 261Kb) (RTF, 437Kb) 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 (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
  • 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
  • treat as confidential all company information supplied for audit or generated after audits

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 Manager, GMP Section – see Feedback to the APVMA below.

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How often Audits are 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 18-24 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.

It should be noted that routine re-audit intervals are determined by the APVMA, not the auditors.

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What is Involved in a GMP 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) (PDF, 79kb)

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How Licences are Issued

Based on the audit report (and any other relevant information) the APVMA may:

  • issue a licence
  • defer issuing a licence until the APVMA is satisfied that all non-conformances have been corrected 
  • refuse to issue a licence (in the case of a new applicant)
  • impose conditions on a licence, 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) (PDF, 90kb), 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 ‘Manufacturer Feedback’ section (Part 2) in the Response to GMP Audit Report form (DOC, 99kb) 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. – refer to Feedback to the APVMA.

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.

It is important to note that the auditors assess the manufacturer’s compliance with GMP requirements;  responsibility for all licensing and regulatory decisions rests with the APVMA.

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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, such consulting audits cannot be used as evidence of GMP compliance for licensing purposes.  Auditing for licensing purposes can only be carried out by APVMA-authorised GMP auditors and 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.

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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, GMP Section.

The Manager, GMP Section 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 and issue an amended licence, 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, and the licence must be issued 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.   A brief follow up audit may be required to ensure systems and procedures have been implemented correctly in an operational environment.

  • 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.

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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, for the purposes of issuing an APVMA licence to manufacture veterinary chemical products. 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.

See the Memorandum Of Understanding concerning Licensing and Auditing of Australian Manufacturers Of Veterinary Medicines (PDF, 87kb) between the Australian Pesticides And Veterinary Medicines Authority and the Therapeutic Goods Administration.

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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.

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Criteria for Refusing, Canceling or Suspending a Manufacturer's Licence

The reasons for refusing, canceling 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.

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Feedback to the APVMA

The APVMA has a mechanism in place to obtain feedback on the auditing process from Manufacturers.  Part 2 of the Response to GMP Audit form (DOC, 99kb) - “Manufacturer Feedback to the APVMA” - asks a series of questions on the conduct of audits, which are intended to provide valuable confidential feedback to the APVMA on the quality and rigour of GMP audits conducted.  Response is not mandatory however strongly encouraged as the responses will assist us in our Quality Assurance Program for GMP Auditors.

In addition, Manufacturers are strongly encouraged to raise any concerns they have regarding any aspects of the MLS with the Manager, GMP Section or Program Manager Veterinary Medicines Program 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.

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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

Contact

Good Manufacturing Practice

  • Manufacture of veterinary chemicals

Phone: +61 2 6210 4899

Fax: +61 2 6210 4741

Email: mls@apvma.gov.au

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