Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations, which come into force on 15 January 1998, prescribe the fees payable in respect of matters under the Animal Remedies Act 1967. That Act controls the manufacture, importation, sale, and use of drugs, etc, used for treating and preventing animal diseases.

The regulations provide, among other things, for—

• (a) Fees payable in respect of an application for licensing of an animal remedy:

• (b) Fees payable in respect of applications for variations to licences:

• (c) Fees payable in respect of applications for “provisional” class 1 licences:

• (d) Fees payable in respect of the reinstatement of a licence:

• (e) The annual fee for holders of licences to manufacture or import an animal remedy, payable on 1 July each year. The Board has power to revoke a licence if the licensee fails to pay any fee in respect of the licence (s 28(1)(na)).

The regulations replace the Animal Remedies (Fees) Regulations 1993 (as amended in 1995).

The regulations introduce differential fees for applications for licences to manufacture or import an animal remedy. The current fee for these applications is a flat fee of $3,150. The new fee is broken down to reflect the number of stages through which an application may need to be processed. These consist of a pre-screening stage, followed by the full processing of the application. The various stages are as follows:

Pre-screening Module

This consists of the administrative pre-screen, followed by the technical pre-screen. All applications received will be progressed through these 2 sub-modules. If there is a deficiency in the application, at the conclusion of this pre-screening section the application will be referred to the Board or its sub-delegated decision-making authority with a recommendation that the application be declined. The total amount payable at this point is $364.50.

Administrative Cost

All applications that are not declined at the end of the pre-screening module will attract a charge of $2,095.88 to cover all administration in respect of the processing of the application. This charge will make up part of the final application fee.

Manufacturing Assessment

Every application will be evaluated under this module. The cost to the applicant per application is $455.63 for costs incurred in respect of an assessment of the chemical identity, properties, formulation details and manufacturing processes, including specifications and analytical methods for all formulation ingredients, and impurities in the final product. An assessment of the stability of the final manufactured product and any use dilutions during storage is included.

Pharmacology and Efficacy Module

Every application must be evaluated under this module. The cost to the applicant for the first named species for which the remedy is to be applicable is $911.25 and for each additional species the cost will be $455.63. This module covers a review of all the data provided on the efficacy and pharmacology. This includes target animal efficacy studies, clinical, and/or field studies, and any other study to justify the claims. The scope of the review will relate to the claims being made per species.

Safety Study Module

Every application will be required to be evaluated for safety purposes for use on the species to which the application relates. The amount of the final fee will be comprised of $455.63 for the first species and $227.82 for every subsequent species. This module covers an assessment of all the data provided on the safety of the product to the target animals. It includes the safety of single and multiple doses, and where appropriate safety to hides and fleeces. The review concerns all claims being made in respect of the product as it relates to one species of animal.

Residues Study Module

Not every application will be subject to this evaluation. Those applications subject to this module will be required to pay $1,093.50 for the first species of animal to which the application relates and $546.75 for any other species to which the applicant wishes the remedy to be applicable to. This module covers an assessment of data showing the nature and level of residues and metabolites resulting from the proposed use-pattern in the target animal and the establishment of withholding periods. It reviews the analytical methods used to determine the residue in the animal products. It also includes an assessment of the effect of any major variable needed to determine the need for, and, if necessary, the establishment of, maximum residue limits.

Toxicology Module

Every application will be processed and evaluated in respect of toxicology. There are 3 different levels that the evaluation may be required to take. The first is the basic information category for which the cost will be $364.50. The next alternative is where a more thorough evaluation is required. The cost in that circumstance will be $911.25. Generally this category will apply where the active ingredient is known to be the same as in other products on the market. The most challenging category is where the active ingredient is new to animal remedies or animal remedies of that type. In that case the cost will be $4,647.38 for the toxicology evaluation component of the application fee.

The most expensive, and most thorough toxicological assessment, relates to an assessment of the full range of acute studies, short term repeat dose studies, sub-chronic toxicity studies, long term toxicity studies, reproduction studies, developmental studies, genotoxicity studies, metabolism and toxicokinetical studies, human toxicological data, special toxicity data (eg neurotoxicity), first aid and safety directions and any other additional data required to make full assessment of the hazard of the product.

The next level down deals with a known active ingredient and the lowest level is the base information level.