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VICH guidelines to be used for antibiotic resistance information requirements

As an outcome of the review of antibiotics, the ACVM Group has altered its information requirements for antibiotic products. Rather than create a separate standard or detail the requirements in Registration Requirements for Veterinary Medicines in New Zealand, the Group has examined the VICH guidelines for providing information on antibiotic resistance to support the registration of antibiotic trade name products. They are considered appropriate and have been adopted as the minimum information required for registration of such products in New Zealand.

The reference to the VICH guideline will be inserted at the next revision of the Registration Requirements for Veterinary Medicines in New Zealand. The VICH guidelines themselves can be viewed on the ACVM Group website through the 'links' pathway.

Good Manufacturing Practice update

Progress towards completion of the mutual recognition agreement for GMP with the EC has been provided in AgVetLink issues 29 and 30. We are now waiting for notification by the Agreement Sub-Committee that the Veterinary Pharmaceuticals Annex has been signed.

Meanwhile the ACVM Group is continuing with its review of the GMP assessment process and implementing revisions as outlined in AgVetLink 30 (Feb 2002).

• AgriQuality New Zealand, the organisation contracted to provide inspection services to MAF, is recruiting staff with the competencies and experience required by the ACVM Group to carry out GMP inspections that fulfil the requirements for inspections of manufacturers of products exported to the EC under the mutual recognition agreement.
• Closer working arrangements have been agreed with Medsafe, Ministry of Health, for the provision of pharmaceutical expertise into the training of GMP inspectors and the conduct of inspections of veterinary pharmaceutical manufacturing premises.
• One collaborative inspection has been carried out by Medsafe and AgriQuality inspectors.
• AgriQuality inspectors will be provided with the opportunity to observe Medsafe inspections of human pharmaceutical manufacturing operations, to align the inspections more closely where it is relevant and appropriate to do so.
• The ACVM Group is reviewing its processes to provide more information to manufacturers that will make regulatory interventions, corrective action steps and time frames clearer for all parties.
• New GMP certificates in the form agreed under the mutual recognition agreement are being provided as inspections proceed.
• The ACVM Group has implemented the definition of deficiencies noted during inspections agreed under the mutual recognition agreement. This can be found attached to the ACVM Standard and Guidelines for GMP on the ACVM website and attached to inspection reports.

Further information will be provided as the ACVM Group works through its ACVM GMP Certification Project, which has been established to review processes, associated documentation, and its communications with regulated parties.

NRA workshop: 27 February - 1 March

Two ACVM Group representatives attended a workshop run by the National Registration Authority (NRA) Australia for organisations/ persons who make applications to register agricultural chemicals and veterinary medicines under the Agricultural and Veterinary Chemicals Act 1994. The two-day workshop to assist applicants in preparing  registration applications covered various aspects, including administrative and technical screening, and what makes a good application.

The workshop provided a good insight into how the NRA processes worked.

This visit also gave the ACVM Group representatives the opportunity to visit the NRA to meet personnel and to discuss a range of topics.

During this visit, informal enquiries were made to the ACVM Group as to whether the Group, in conjunction with ERMA NZ, would hold a similar workshop in Australia.

The ACVM Group will consider this for the future and would welcome comment from Australian companies as to the merits of such a workshop.