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News and Views for October 2009

Have your say on proposed changes to ACVM Regs

The public discussion document on proposed changes to the ACVM Regulations is now available. Let us know what you think — submissions close 30 October 2009.

Efficacy IS important

Rumour has it that NZFSA does not care about efficacy when evaluating veterinary medicine product applications. WRONG! Efficacy is, and always has been, an important consideration. For most veterinary medicines, lack of efficacy has animal welfare implications so, with a few notable exceptions, it forms part of the assessment process.

NZFSA’s expectations of ‘responsible manufacturers’

The ‘responsible manufacturer’ is the entity that ensures the ACVM registered trade name product is in compliance with its current registration and releases it for sale. NZFSA expects responsible manufacturers to have systems in place to ensure this process is well controlled.

Operating plan expected

Therefore, responsible manufacturers of all trade name products are expected to have an operating plan (a document that describes how the product is manufactured in compliance with its current registration).

For most veterinary medicines and vertebrate toxic agents (VTAs), this operating plan will be approved by NZFSA under section 28 of the ACVM Act. In these cases there will be an active compliance programme.

Manufacturers of products that do not have to have an NZFSA-approved operating plan as a condition of registration will be reviewed only if there is an investigation as a result of a complaint or information supplied to NZFSA.

Requirements of responsible manufacturers

• Procedures should outline the steps taken to release the product for sale. Records of each step should be generated and retained. The procedure should include:

- A review of documents supplied by the manufacturer. These documents may be in the form of a Certificate of Analysis or a copy of the actual manufacturing and quality control records.

- The physical check of product to ensure it is labelled correctly with batch number and expiry date.

- The registered release specifications. These should be used to check against quality control (QC) results prior to release. The specifications must be consistent with the data approved as part of the registration package.

- The way any non-conformities or deviations from the production process etc will be assessed for any potential impact on the quality of the product. This assessment can be completed by the contract manufacturer but the responsible manufacturer should ensure that they are in agreement with this assessment.

• Individuals responsible for releasing products should be trained appropriately. Records of this training should be kept.

• There should be a contract that outlines the responsibilities of both the responsible and contract manufacturers. This should ensure there is no duplication or omission, eg, which party will hold the required retention samples. (Refer to chapter 7 of the ACVM Guideline for GMP.)

• There should be a procedure that covers the actions the responsible manufacturer will take in the event of a complaint or recall.

• An internal audit of the above activities should be performed annually to ensure they are still appropriate.

Reminder-- How NZFSA will regulate responsible manufacturers

In early 2010 NZFSA will contact responsible manufacturers that have been nominated on the updated Registration and Product Datasheet (PDS) unless they are already part of the current good manufacturing practice (GMP) programme. Responsible manufacturers that require NZFSA approval will be subject to an initial desk top audit, which will assess the manufacturer based on the requirements listed below. Following this, biennial on-site audits will be conducted. These will likely take 1-2 hours, depending on the complexity of the operation of each company, and will be planned to coincide when other audits are being performed in the area to reduce cost. All audits will be cost recovered.

If product is released for sale by an overseas manufacturer who is listed as the responsible manufacturer, their GMP certificate will provide sufficient assurance of compliance to the requirements above.

FairAd

FAIRAd (Forum for Animal Health Industry Regulation of Advertising), which was launched on 30 November 2006, is the industry’s mechanism to self-regulate standards for advertising veterinary medicines. It aims to ensure users that they can be confident in claims and information presented in promotional material such as advertising and sales materials. The initiative encourages high standards and self-regulation of promotional activities of animal health companies, distributors, veterinary practices and other animal health retailers.

However, FairAd is not being utilised by all of industry and NZFSA is frequently asked to provide an opinion on advertising claims. We will look at ad content that relates to ACVM Act requirements but we will refer all other advertising disputes to the Commerce Commission if parties are not willing to use the services of FAIRAd. If the Commission needs technical support to resolve a dispute, NZFSA will provide it.

Group Standards Workshop

August, Wellington

This workshop, which was organised by NZFSA and ERMA NZ, covered the roles and responsibilities of the two organisations, how group standards work, and industry perspectives (pros and cons). The main emphasis was on how group standards could work for veterinary medicine products. Representatives from Agcarm and ARPPA attended.

Key points from the workshop:

• It identified a number of opportunities for group standards. This would mean that applicants for trade name products covered by the Hazardous Substances and New Organisms (HSNO) Group Standard would only need to apply to NZFSA instead of to both organisations.

• Appropriate new group standards could significantly reduce the numbers of ERMA applications required. This would reduce compliance costs for industry and free up ERMA NZ staff to work on more significant issues without decreasing risk management.

• It identified an opportunity to link to the current work to develop a group standard for the (human) pharmaceutical active ingredients with veterinary medicine active ingredients. These ingredients are used solely in manufacture where the related HSNO risks are managed via good manufacturing practice (GMP) or by quality systems.

• Discussion identified that it may be possible to cover agricultural chemical actives by a group standard as the main HSNO concerns are around the wide dispersive use of formulated products, but actives are used solely in formulation or manufacture.

• There were concerns from some attendees. These mainly related to the potential for ‘generic’ manufacturers to ‘free ride’ and not face the same compliance costs as the innovative company.

Attendees felt the workshop was worthwhile and clarified a number of aspects surrounding group standards and the roles and responsibilities of each regulator. To progress group standards it was agreed that NZFSA’s Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC) be asked to establish two working groups (one for veterinary medicines and the other for agricultural chemicals).

Data Assessment Service (DAS) Workshop

September, Auckland

NZFSA held this workshop to discuss the DAS and ideas for improvements to its shape for the future. Representatives from Agcarm, ARPPA and consultants attended.

A number of useful suggestions were made, including:

• more and regular feedback on the performance of DAS assessors by NZFSA

• regular training sessions for DAS assessors

• list of DAS assessors on the NZFSA website

• system to determine competency of DAS assessors

• explicit guidance on expectations of DAS assessors.

We received a clear message that the DAS system should continue in its current form but be improved by implementing some of the suggestions above. This would mean more applicants using third party DAS assessors, rather than NZFSA’s DAS.

NZFSA agreed to use the Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC) to establish a working group to progress the workshop suggestions.

Visit by ICAMA (Chinese national pesticide regulators)

July, Wellington

NZFSA hosted a three-person delegation of Chinese pesticide regulators from the Institute for the Control of Agrochemicals from the Ministry of Agriculture (ICAMA). The visit followed on from meetings held with ICAMA representatives, NZFSA and the New Zealand Embassy during the Codex Committee on Pesticide Residues (CCPR) meeting in April 2009.

The purpose of the visit was to gain an understanding of how each regulator operates and to develop a closer working relationship. Our presentations explained:

• how NZFSA operates

• how we regulate pesticides under the ACVM Act

• how MRLs are set, and

• how compliance under all the Acts NZFSA administers is managed.

ERMA NZ provided presentations on the interface of the ACVM and HSNO Acts. The Chinese delegation provided an overview of the system in China, and we discussed areas of mutual interest such as harmonisation of information requirements between both countries, working closer together at CCPR and on compliance matters.

The visit was successful as each regulator now has a better understanding of how the other operates and has built a foundation for a closer working relationship in the future.

OECD meeting in Japan

16-20 November, Tokyo

Warren Hughes will attend the upcoming OECD meetings. The two main meetings are the Registration Steering Group and Risk Reduction Steering Group, along with a one-day seminar on agricultural chemical use in and around urban areas. There will also be a meeting for government-only representatives to discuss regulatory matters and a joint industry/government meeting to discuss work sharing activities.

Topics to be covered include:

• risk reduction measures such as reducing spray drift

• training of operators

• MRL calculator and policy issues surrounding its use

• joint reviews

• electronic exchange of pesticide data.

Bait station definition

Registrants asked NZFSA to define ‘bait station’ more transparently to enable registrants/users to see exactly what we mean when products must be used in a bait station/bait bag etc.

We are consulting with registrants, others in the vertebrate toxic agent (VTA) industry, and the government departments that work with VTAs (eg, ERMA NZ, Department of Conservation, MAF Biosecurity) to develop this definition. Watch this space.

If you request a meeting…

If you request a meeting with us, there are some basic ground rules.

• Contact Maree Zinzley to set up a time when staff required can be available — 3 weeks’ notice is usually needed.

• Supply an agenda ahead of time so we can gather any documentation needed.

• Chair the meeting and have someone from your company take minutes — we will comment on the minutes but it is your responsibility to provide them.

Remember — it’s your meeting, so you are expected to run it.

(Meetings are charged at the hourly rate of $149.60 inc GST per NZFSA person attending.)

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