ACVM guidance for veterinarians
If you're a vet, you have certain legal requirements around using ACVMs. Get information and guidance on the requirements, and on working with ACVMs.
On this page:
- Managing product risks
- Deciding on treatment
- Using products off-label
- Importing in special circumstances
- Compounding veterinary preparations
- Residues and withholding periods
- Selling veterinary medicines
- Conducting 'trials'
- Adverse events
- Approved operating plans
- Keeping records
Using vet medicines
When you recommend, use, or authorise the use of products to treat animals, you have to meet certain legal requirements. The ACVM requirements are detailed on this page.
The Veterinary Council of New Zealand (VCNZ) Code of Professional Conduct also has guidance on how to prescribe and use veterinary medicines.
As a veterinarian, you're an important risk manager for veterinary medicines. You need to:
- consider and mitigate the risks that using a product might pose to public health, trade in primary produce, agricultural security, and animal welfare
- give appropriate advice on managing residues and withholding periods in food-producing animals
- manage risk when advising on using products off-label.
There are also risks around complying with conditions of:
- product registration
- exemption for exempt products.
For guidance on managing the product risks, refer to the information below:
- Products exempt from registration
- Products that claim to treat pain or distress
- Registered veterinary medicines
- Restricted veterinary medicines
Products that fit one of the ‘exempt from registration’ categories in the ACVM (Exemptions and Prohibited Substances) Regulations 2011 are only exempt if the relevant exemption conditions are complied with.
Be aware of the exemption conditions if you're recommending or using exempt products.
- ACVM (Exemptions and Prohibited Substances) Regulations 2011
- ACVM Notice: Agricultural compounds exempt from registration: Requirements for conditions of exemption [PDF, 438 KB]
- Obligations under the ACVM Regulations guideline [PDF, 242 KB]
There are no exemptions in the regulations for products that claim to treat a disease characterised by pain or distress. These products must always be registered because of the animal welfare risks.
Registered veterinary medicines all have registration conditions to manage risks. Some conditions apply directly to the responsible veterinarian. Make sure you know the conditions for every product you recommend, authorise, or use. This applies to over-the-counter products as well as restricted products.
Check the ACVM product register for registered veterinary medicines and their conditions.
A ‘restricted veterinary medicine’ (RVM) is registered with extra restrictions on its sale, purchase, and use. Using these products poses greater risks than unrestricted products, which you need to manage.
If you're a veterinarian with a current practising certificate from the VCNZ, you can issue veterinary authorisations for the purchase and use of RVMs. This recognition carries significant legal obligations (in addition to authorisation). The obligations relate to managing sales, labelling, and recordkeeping. They're set out in this ACVM Notice:
Requirements for Authorising Veterinarians Notice [PDF, 219 KB]
To help you authorise the use of veterinary medicines, we've got guidelines for issuing robust veterinary operating instructions (VOIs) for non-veterinarians to use for:
- RVMs (including RVMs for velvet antler removal)
- veterinary medicines that are exempt from registration subject to veterinary control.
Veterinary operating instructions guidelines [PDF, 231 KB]
This authorisation recognition doesn't extend to selling RVMs. All selling activities (including distribution, storage, dispensing, and supply) are subject to the conditions of registration that specify who can sell RVM products.
There are requirements for choosing and/or using antimicrobials.
- You must undertake a veterinary consultation (following the relevant MPI and VCNZ guidance and requirements).
- You must know the history of the herd, flock, or animal(s) being treated.
- You must comply with any legal obligations associated with using the chosen treatment.
- Your choice of antimicrobial must not be influenced by financial incentives and/or convenience.
- Your choice of antimicrobial must follow the:
- cascade principles under the VCNZ’s Code of Professional Conduct – see ‘Deciding on treatment’
- principles of managing and preventing antimicrobial resistance.
When choosing which antimicrobial (registered veterinary medicine, human antimicrobial for use on animals, or compounded veterinary preparation) you will authorise, you must consider:
- Is there an infectious condition or known exposure to a pathogen that clearly indicates that using an antimicrobial is the appropriate treatment?
- Is there a need to do culture and sensitivity testing to confirm the pathogen and appropriate treatment?
- Are there any restrictions or contraindications for use of the antimicrobial in treating animal(s) that must be considered?
- If it's a food-producing animal being treated, what withholding periods need to apply to the antimicrobial and any concurrent treatment(s)?
- What's the shelf life of the product to be authorised? (The period of authorisation must not exceed the shelf life.)
New Zealand relies on you, as a veterinarian, to be a good steward of veterinary antimicrobials. We've got information on product use of antimicrobials, as well as background policy/sales reports and the action plan to deal with antimicrobial resistance.
When deciding what product to use, follow the risk management-based product-use cascade.
Risk management-based product-use cascade
Number 1 products should be your first choice. They've been ACVM risk-assessed for veterinary use.
- On-label use of a New Zealand-authorised (under the ACVM Act) veterinary product
- Off-label use of a New Zealand-authorised veterinary product
- Off-label use of a New Zealand-authorised (under the Medicines Act) human medicine
- Import of an overseas product (veterinary product preferred but human product acceptable)
- Use of a compounded veterinary preparation.
Off-label use means any change from following the written instructions for use provided with a product.
For example, the product might be used to treat a different problem that isn't listed, or a different dosage might be followed.
Before choosing to use a product off-label, carefully consider options. Don't use any registered veterinary medicine off-label unless you can justify and manage the risks.
If you're not recommending off-label use for a product but you're asked for advice about off-label use, you should:
- be prepared to offer advice on use and withholding periods, or
- advise against off-label use if there's a suitable alternative as per the cascade above.
Off-label use is prohibited for some products
Some products are registered with conditions that prohibit using them off-label, for example:
- Condition 31: This product must only be used as specified in the label content.
- Condition 97: This product must only be used in the species identified on the label.
Check the conditions on any registered product you are considering using off-label.
Off-label use and food-producing animals
If you're recommending or using a product off-label in a food-producing animal, you're legally responsible for determining a suitable withholding period (WHP) to manage residues and compliance with the maximum residue level (MRL).
If there isn't a suitable authorised product available in New Zealand for your treatment, you can request approval to import a product. This is done under the 'special circumstances' provision of the ACVM Act. Under the provision, MPI can allow the import, manufacture, sale, or use of an unauthorised veterinary medicine without registration.
You'll need a special circumstances approval granted by MPI before you can import products from overseas. There may also be other approvals needed from:
- the Ministry of Health, and/or
- MPI (under the Biosecurity Act), and/or
- the Environmental Protection Authority (EPA).
This will depend on the product. Refer to the guideline and application form to find out more.
- Special circumstances approval — ACVM information requirements [PDF, 297 KB]
- Application to import for special use [DOC, 733 KB]
Compounding means making, preparing, producing, or processing a veterinary preparation for animals you're treating. Veterinarians can compound veterinary preparations under the ACVM (Exemptions and Prohibited Substances) Regulations 2011. There are strict conditions and requirements around this. Compounding should only be done when no suitable product is available.
Our product-use cascade can help you decide what treatment to use.
If you plan to compound a veterinary preparation, use this guideline for information on your ACVM obligations and advice on developing a documented system:
The withholding periods (WHPs) on product labels are set based on the on-label use of the product. This ensures compliance with the maximum residue levels (MRLs) for the active ingredient(s) in the product.
The on-label WHPs are based on trial data that's evaluated as part of the product's registration. It may not be applicable to all clinical circumstances. If an animal is treated in a situation that doesn't fit the typical clinical circumstances (like when an animal shows signs of liver or kidney disease), consider extending the WHP.
Legal obligations around WHPs and off-label use
If you choose to use any product in an off-label or unapproved way, you're legally responsible for ensuring the WHP is appropriate to manage residues for all active ingredients administered. This includes using multiple products at the same time. Make sure you always record your WHP advice as part of the authorisation (for RVMs) and the clinical treatment record.
- Default withholding periods for veterinary medicines
- Prohibited and restricted substances
- Phenylbutazone use in horses – Advice for veterinarians
Exempt from registration, unrestricted, and restricted veterinary medicines (RVMs) have different requirements when it comes to advertising and selling them.
You can use a veterinary medicine as you see fit when responding to a clinical need, but you must manage the ACVM risks. Keep records of instructions, administration, adverse effects, and outcomes.
You must not use treatments in response to a clinical need as field or clinical trials unless you have:
- established a trial protocol, and
- received Animal Ethics Committee approval before beginning the trial.
Check the New Zealand Veterinary Association guidelines.
If your trials involve unregistered veterinary medicines that would require registration (like medicines that wouldn't be exempt from registration if they were sold), you must get an MPI approval to conduct trial work on that medicine before beginning the trial.
Adverse events include any unexpected outcome relating to:
They can stem from:
- products you've authorised
- unrestricted product use that has caused issues you become aware of (or have to treat for)
- animal feeds issues you know about or treat for.
An operating plan (OP) explains how an organisation will control activities they carry out. This includes:
- the planning process for each individual activity
- how the organisation plans to assess risk, and
- how the organisation will record and internally audit the activities carried out under the OP.
You must have an MPI-approved OP when:
- having and complying with an approved OP is a condition of product registration, like selling RVMs (as a veterinarian, you don't need an MPI-approved operating plan to sell RVMs if you only supply RVMs authorised by veterinarians in your practice)
- having and complying with an approved OP is a condition of exemption from registration, like an approval in special circumstances, conducting research, testing, teaching, or training.
OP guidelines and forms
- Operating plans relevant to the ACVM Act guideline [PDF, 126 KB]
- Operating plans for RVM sellers guideline [PDF, 180 KB]
- Operating plan template for RVM sellers (ACVM 28) [DOC, 554 KB]
- ACVM expectations of HGP sellers with an approved operating plan [PDF, 157 KB]
- Operating plan template for HGP sellers (ACVM 27) [DOC, 448 KB]
- Operating plans for RTTOs guideline [PDF, 157 KB]
- Operating plan template for RTTOs (ACVM 26) [DOC, 451 KB]
- Operating plan application form for RTTOs (ACVM 26A) [DOC, 431 KB]
Good record-keeping is an essential part of risk management. The VCNZ Code of Professional Conduct has record-keeping advice, but for ACVM products, keep written records of:
- instructions for use for RVM authorisations, and advice given for use of unrestricted products
- instructions/use different from what is approved for the product (with reasons)
- concurrent treatments
- withholding period advice you gave
- circumstances that make the case unusual.
Record-keeping for food-producing animals
The treatment of food-producing animals also has record keeping requirements under the Animal Products Act, especially if a risk management programme (RMP) applies.
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