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AgVetLink August 2003

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International scene

Development of a Memorandum of Understanding with Australia

The ACVM Group is developing a Memorandum of Understanding (MoU) on good manufacturing practice (GMP) with the Australian Pesticides and Veterinary Medicines Authority (APVMA).

The harmonisation of regulatory control on agricultural compounds and veterinary medicines is excluded from the Trans-Tasman Mutual Recognition Agreement (MRA). However, in spite of the exclusion, for a number of years the ACVM Group and the APVMA have operated an informal agreement to recognise the competence of each other’s manufacturers of veterinary medicines, and their compliance with GMP standards. This arrangement has been possible because of the development of a close relationship between the two regulatory authorities and regular visits during which issues of mutual interest are addressed.

Now that the APVMA has fully implemented its GMP inspection programme and is moving to adopt the single GMP standard used by New Zealand and the EC under the MRA for GMP, it is appropriate that the arrangements in place with Australia should be formalised within a MoU.

Progress:

There is agreement in principle from both parties. The ACVM Group has developed a draft MoU which is with the APVMA for comment.

 

Labelling Guide requirements

The ACVM Group’s requirements for the label content of veterinary medicines and plant compounds are stated in the respective Labelling Guides. Every effort is made by the ACVM Group to ensure the label content of registered agricultural compounds complies with the requirements of the Labelling Guide during the approval process.

However, registrants are reminded that ultimately it is their responsibility, and not the ACVM Group’s, to ensure all product labels comply with the Guide. Where the ACVM Group or registrant detects non-compliance with the Labelling Guide for any registered product, it is expected that labels be brought into compliance at the next reprint, regardless of any prior approval.

 

Technical Agreement for Official Batch Release – Veterinary Vaccines

The ACVM Group is collaborating with the Veterinary Medicines Directorate (VMD), United Kingdom, to enter into a technical agreement under which the ACVM Group would perform Quality Assurance/Quality Control (QA/QC) inspections for official batch release of veterinary vaccines on behalf of the VMD.

The process for the release of each batch of veterinary vaccine onto the market by a regulatory authority in the European Community is called ‘official batch release’. All the European regulatory authorities, with the exception of the VMD, enable batch release of veterinary vaccines through sampling and testing provisions in the European Directives. The VMD operates a different system in the UK under which a system of QA/QC inspections of manufacturers of veterinary vaccines, carried out annually, replaces batch sampling and testing. These annual visits by UK inspectors for QA/QC inspections are expensive for New Zealand manufacturers exporting vaccines to the UK.

The ACVM Group and the VMD have reached agreement in principle that it is possible for New Zealand inspectors to perform QA/QC inspections of veterinary vaccine manufacturers’ quality systems on behalf of the VMD after an appropriate transitional period for mutual confidence of both regulators. It is agreed that the 2003 cycle of inspections will be carried out jointly and collaboratively by both regulatory authorities. It is also agreed that the next cycle of inspections (due in March 2004) will be carried out by the New Zealand inspector and observed by the VMD inspector. Successful completion of this programme will form the basis of a technical agreement between the VMD and the ACVM Group for the conduct of future QA/QC inspections by the ACVM Group on behalf of the VMD.

Progress:

The 2003 cycle of inspections has been completed successfully, and the ACVM Group and VMD are both confident that the programme should be completed on schedule in April 2004.