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New look conditions of registration for veterinary medicine trade name products

November 2009

After consultation with the Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC), NZFSA has revised the set of conditions of registration for veterinary medicine trade name products. This was done:

• to support the new restricted veterinary medicine (RVM) system

• to clarify conditions to ensure regulated parties clearly understand their obligations

• to correct deficiencies in the existing conditions governing import, manufacture, sale, distribution, authorisation and use that may limit NZFSA’s ability to take regulatory action in relation to activities that (in NZFSA’s view) create significant risks that are relevant to the ACVM Act.

For the most part, wording of the conditions was changed to clarify existing statutory obligations rather than to change them. However, there are a few new obligations.

Conditions on all veterinary medicines

While the decision to apply conditions is made for each registration, in practice the same conditions repeatedly appear on registrations because in every case a veterinary medicine product:

• must conform to and be manufactured in accordance with its approved specifications

• must be labelled in accordance with its approved specifications

• must be manufactured only by a specified party with approved operating plans

• must be maintained properly to prevent deterioration, contamination or defacing

• must be advertised only in a manner that is consistent with its approved specifications, and

• should not be the cause of non-compliant residues or unnecessary or unreasonable pain or distress in the animal treated.

Also, each ACVM product file must be kept current in light of any adverse event or other new information.

Conditions that apply to registrants

The registrant has the primary responsibility to ensure that the product is what it is supposed to be. The conditions make it clear to registrants that they must only release compliant products into the New Zealand market and only advertise or promote them in a manner that is consistent with their registration. While the wording has changed to make the obligations more precise, there are no new obligations imposed in the following conditions:

• The manufacture of the product must, at all times, comply with the product and manufacturing specifications approved as part of this registration.

• The product must be labelled in accordance with the product and manufacturing specifications approved as part of this registration.

• The product must be manufactured by a person specified to manufacture it and acting in accordance with an operating plan approved under section 28.

• For the purposes of this condition, an adverse event is any event that brings into question the relevance or reliability of information provided at the time of registration and upon which the decision to register the product was made.

The registrant must notify NZFSA of an adverse event in relation to the product:

a. immediately upon becoming aware of the event, where the event has or may have serious implications for the continued use of the product

b. within seven (7) working days of becoming aware of the event where the event has or may have significant implications for the continued use of the product.

• The registrant must, as soon as practicable after becoming aware of new information, advise NZFSA of any new information that relates to the relevance, reliability or correctness of information provided at the time of registration and upon which the decision to register the product was made.

• No advertisement for the product may:

a. include content or be presented in a manner that does not conform to the approved product and manufacturing specifications (this includes approved uses)

b. contain false or misleading claims, statements or information in relation to the product

c. without limitation to the generality of b, directly or by implication make false or misleading claims or statements about the regulatory status of the product under the ACVM Act.

Conditions that apply to wholesalers and retailers

In addition to registrants, other parties advertise, promote and sell veterinary medicine trade name products. The advertising condition listed above also applies to them. No one may misrepresent a registered veterinary medicine trade name product or advertise/promote its sale for a use that has not been approved.

Parties who transport, store and sell such products have an additional responsibility to take care to avoid deterioration or contaminations of products while they are in their care. The latter condition is a new obligation. It has been imposed because wholesalers and retailers, through neglect and mismanagement, can cause deterioration, contamination or defacing of the products they sell.

The conditions wholesalers and retailers must comply with are:

• Persons responsible for the product at each stage throughout its distribution must maintain the product in a manner that ensures it conforms to the approved product and manufacturing specifications through to the product’s retail sale.

• No advertisement for the product may:

a. include content or be presented in a manner that does not conform to the approved product and manufacturing specifications (this includes approved uses)

b. contain false or misleading claims, statements or information in relation to the product

c. without limitation to the generality of b, directly or by implication make false or misleading claims or statements about the regulatory status of the product under the ACVM Act.

The conditions imposed on registrants, wholesalers and retailers are imposed to ensure that the purchaser can have confidence that the product is what it is supposed to be.

Conditions that apply to users

It is a breach of the advertising condition for registrants, wholesalers and retailers or any other person to advertise or promote the sale of a veterinary medicine trade name product for unapproved uses. However, it is not an offence for a person to use it, unless the particular use has been prohibited in some other condition of registration (ie, a condition specific for that product).

• Any person using the product on any animal from which animal material as defined in the Animal Products Act 1999 is likely be used for human consumption (whether that use is in accordance with the approved product label or not) must ensure that residues of any substance in the product that may occur in animal material produced from the treated animals, do not exceed the lower of either:

a. the specified residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments, or

b. where a maximum residue limit for that substance has not been specified, the default maximum residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments.

This is a more comprehensive obligation than it was under the old condition of registration. It makes it an offence to fail to take care to avoid non-compliant residues in all cases, whether the use is approved or not.

The recommended withholding period on the label is the best guide for approved uses and it is advisable (but not a statutory obligation) to follow that advice. That advice may not be appropriate as guidance for an unapproved use. The new condition should encourage the user to take the initiative and seek appropriate guidance in all cases because it will be an offence to fail to take care to avoid non-compliant residues.

• Any person using the product on any animal or in any manner other than as specified in the approved product and manufacturing specifications must, before using the product, seek advice from an appropriately qualified source and confirm that the intended use is not likely to cause unnecessary or unreasonable pain or distress in the animal treated.

As above, the user should follow the instructions for use provided with the product as the best guidance to avoid unnecessary pain or distress in the treated animals. However, if the use is not approved there will be no relevant use instructions to follow. While the use is permitted if it is not specifically prohibited, the user must take the initiative, seek expert advice and take care to avoid unnecessary or unreasonable pain or distress to the animals treated.

Conditions restricting the sale, purchase and use of certain veterinary medicine trade name products

The conditions listed above would apply to all registered veterinary medicines trade name products. However, there are some veterinary medicine trade name products that require additional controls on:

• who can sell them

• how they can be advertised and sold

• who can purchase them

• who can use them

• how they can be used

• who can authorise their purchase and use, and

• how that authorisation should be issued.

The products that currently attract these kinds of controls are known as prescription animal remedies (PARs). Under the new conditions of registration they will be known as restricted veterinary medicines (RVMs).

The relevant conditions are:

• The product must be sold only by either:

a. a registered veterinarian holding a current practising certificate issued under the Veterinarians Act 2005 in the course of his or her own veterinary practice, or

b. a person specified to sell the product or similar products in and acting in accordance with a relevant operating plan approved under section 28 of the ACVM Act.

• For the purposes of this condition, ‘veterinary authorisation’ means that a registered veterinarian with a current practising certificate issued under the Veterinarians Act 2005 has issued a valid authorisation for its purchase and use.

Any advertisement of this product must contain a statement that the product is available for purchase and use only under and in compliance with a veterinary authorisation.

• The product must be sold only to:

a. a person specified in an approved operating plan, or

b. any person in possession of a valid authorisation either:

i. issued by a registered veterinarian holding a current practising certificate issued under the Veterinarians Act 2005, or

ii. issued under, and in accordance with, an approved operating plan.

• The product must be used only under the authority of ,and in compliance with, a valid authorisation issued either:

a. by a registered veterinarian holding a current practising certificate issued under the Veterinarians Act 2005, or

b. under, and in accordance with, an approved operating plan.

• All veterinarians who are recognised under section 62 for the purpose of issuing a valid authorisation for the purchase and/or use of the product must comply with any performance and technical standards issued by the Director-General, and for the time being in place, under section 62(5) of the ACVM Act, for authorising this type of product.

The conditions of RVMs that relate to who can sell and who can purchase and use are basically the same as they were for PARs. They depend, for the most part, on veterinary authorisations (previously known as veterinary prescriptions) with authorisations via approved operating plans as an alternative.

The only significant new components of regulatory control are:

1. the formal recognition of veterinarians as persons who can issue valid authorisations to purchase and use RVM trade name products

2. the expressly stated obligation on veterinarians to comply with the ACVM performance and technical standards governing veterinary authorisation.

Product-specific conditions

Apart from all the conditions listed above that are commonly applied to veterinary medicine trade name products, NZFSA can impose other conditions that are considered necessary to manage the ACVM risks posed by particular products. These have been and will continue to be developed and imposed on a case-by-case basis.

Application of the new conditions of registration

As of 1 January 2010 all new registrations will be issued with the new conditions. New labelling requirements will be discussed with the applicant and label content will have to comply with any new requirements in regard to regulatory statements.

All variations in registrations and registration renewals will be issued with the new conditions, but compliance with any new labelling requirements will be discussed with the registrant and a timetable for conversion to new labels will be set on a case-by-case basis.

For those products with harmonised New Zealand/Australian labels, the impact of label changes will be discussed with APVMA and a mutually satisfactory compromise that retains the current flexibility will be reached.