Guidelines for Registration of Allergenic Substances
Guideline No. 31
Release date: 8 June 2001
On this page:
1. Chemistry
- each allergen, or allergenic extract, included in the formulation is to be identified by a common name, and where applicable, a scientific name;
- allergens are to be grouped under headings where possible e.g. grasses, weeds, trees and shrubs, cultivated plants, flowers, molds, dusts, mites, insects, animals etc and listed in alphabetical order by the common name;
- the concentration (expressed preferably as protein nitrogen units);
- of individual allergens is to be provided;
- where the protein comprising an allergen has been identified, the allergen should be standardised against that protein e.g. a specific enzyme in bee venom;
- with many allergens including various pollens, the protein of interest has not been characterised and such allergens should be standardised in terms of total protein;
- for products in which several allergenic extracts of a particular category (e.g. grass allergens) are pooled, the concentration of the resultant mixture is to be provided;
- the names and concentrations of diluents are to be provided;
- data supporting the storage conditions and shelf-life of the product are to be provided.
2. Manufacture and Quality Control
- name and address of the manufacturer of the allergenic extracts are to be provided;
- name and address of the manufacturer of the formulated (injectable) product are to be provided;
- evidence that the vaccine is manufactured according to a Code of Good Manufacturing Practice, or in a USDA licensed facility, or the equivalent, is to be provided;
- the Standard Operating Protocols for antigen production and protein assessment, compositional analyses, batch analyses, microbial contamination control (i.e. methods for ensuring sterility) and general safety are to be documented (copies of relevant sections/pages of the Manufacturers Manual will suffice);
- the quality control procedures involved in preparing/diluting the ;allergens for injection are to be documented.
3. Efficacy Data
- product claims are to be substantiated by data and/or argument;
- although data from controlled clinical trials are preferred, the provision of such data is not mandatory on account of the nature of, and the use patterns associated with, these products;
- where clinical data are not provided to substantiate the product claims, literature from reputable refereed scientific journals and/or textbooks which describe the clinical efficacy of the product in the target animals is to be provided;
- evidence that the product has been tested on normal and allergenic (diseased) dogs is to be provided;
- evidence that the product can discriminate between normal and diseased dogs is to be provided;
- information pertaining to the clinical testing of the product under Australian conditions is to be provided;
- the use of antigens prepared or purified from source biomaterials that did not originate from Australia is to be validated (i.e. the allergens must be demonstrated to be relevant to Australian conditions).
4. Safety to the Target Species
- potential adverse reactions to the target species are to be described;
- any adverse drug reaction reports for allergenic products similar to the product under review are to be provided;
- all potential risks to the target species are to be kept in perspective in terms of use patterns e.g. product intended for use by or under the supervision of a registered veterinary surgeon, the success rate for the treatment of adverse reactions etc.
5. Safety to Humans
- literature describing the use of similar allergens in humans, the types and incidences of adverse reactions in humans, and the management of these adverse reactions, is to be provided.
6. AQIS Import Permit
- a copy of a current AQIS Import Permit(s) is to be included with applications involving imported biological components.
7. Label
- the label must comply with the current edition of the Code of Practice for Labeling Veterinary Chemical Products;
- an example of a label lay-out is shown below for a hyposensitisation vaccine (intended for subcutaneous injection, as opposed to a diagnostic vaccine intended for intradermal administration);
- label warnings relating to concurrent immunosuppressive therapy are to be included in the Restraint section of the Package Insert;
- note that although Batch may not be entirely appropriate for this category of product, it is nevertheless essential that the product be identified in a manner which will allow traceback should the need arise.
Vial Label
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PRODUCT NAME
ACTIVE CONSTITUENTS: Allergenic Mixture/Concentration
MEDICINAL CLAIM
CONTENT (of the single vial)
For subcutaneous injection only
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
BATCH
EXPIRY
STORAGE
MANUFACTURER'S NAME and ADDRESS
MANUFACTURER'S TELEPHONE NUMBER
Carton Label
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PRODUCT NAME
ACTIVE CONSTITUENTS: Allergenic Mixture/Concentration
MEDICINAL CLAIM
CONTENTS: n x v mL Vials (where n = number of vials in the carton and
v = volume of each vial)
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
For subcutaneous injection only
For use by, or under the supervision of, a registered veterinary surgeon
DISPOSAL STATEMENT
STORAGE
BATCH
EXPIRY
MANUFACTURER'S NAME and ADDRESS
MANUFACTURER'S TELEPHONE NUMBER
Package Insert
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PRODUCT NAME
ACTIVE CONSTITUENTS: Allergenic Mixture/Concentration
MEDICINAL CLAIM
DIRECTIONS FOR USE
For subcutaneous injection only
For use by, or under the supervision of, a registered veterinary surgeon
INFORMATION RELATED TO THE PRODUCT and/or ITS USE
MANUFACTURER'S NAME and ADDRESS
MANUFACTURER'S TELEPHONE NUMBER
STORAGE
DISPOSAL STATEMENT