Hi, some explanatory notes were published in one of our UK racing pigeon magazines last year. Have posted cut-down version for your info.
British Homing World October 7th,2005
Veterinary Medicines – Small Animal Exceptions Scheme.
New regulations will be published that contain an exemption from the requirement for a marketing authorisation (ma) for certain veterinary medicines.
This exemption scheme applies to veterinary medicines labelled exclusively for use in one or more of the following animals: aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents and terrarium animals.
A draft guidance and information note (14) is enclosed, also available at
www.vmd.gov.uk
Further questions about the scheme to:
s.hack@vmd.defra.gov.uk Small Animal Exceptions Scheme (saes) – Information Note
A public consultation was held in January 2004. A guide to the actions needed to market a product under the saes scheme is given. The regulations come into effect on 30th October 2005 but certain parts of saes have been deferred until 1st November 2007.
Products currently on the market without an ma:
..may only be administered to the groups of animals included in the scheme – other species must be deleted from the indications.
Products which are antibiotics, narcorics, or psychtropic drugs must be withdrawn from sale, as these do not fall under the scheme. Products must not be for parenteral or ophthalmic administration or for administration into the ear canal. Fish treatments administered via the water but not intended for ophthalmic administration are permitted.
Products that you wish to market after 1st November 2007 (including current products) - Submit the active ingredient details to us
- We will consider these and inform you of our decision
- We will publish ingredients we deem suitable to be included in the scheme
- Apply for ma
- If manufactured overseas, ensure site has ma license AND import license
- Amend the product labelling ‘this veterinary medicine is marketed in accordance with the saes’
- Ensure pack sizes are only sufficient for single course of treatment
Standard format for active substance details Name of active substance
Standard English name, for herbs use Latin species name.
Species to which substance will be administered
Ornamental fish, pigeons, cage birds, terrarium animals (reptiles, amphibians, insects) small rodents (specify hamsters, guinea pigs, mice, rats, chinchillas or others) rabbits, ferrets.
Indications
The name of the disease to be treated.
Route of administration
Specify topical, oral, or any other route.
The pack size
The maximum pack size that will be marketed.
The concentration of the active substance
Use standard terms of mg/ml, mg/tablet etc.
The directions for use
The dosage rate, frequency of treatment and any other information to be provided to the user.
Your justification for requiring this substance in the scheme
Provide information on alternative authorised products (or lack of) welfare issues if product were to be lost from the market, experience of safe use (including date of first use / length of time product has been on market) and any other information you consider helpful. Please do not submit any studies or reports unless requested.
As you can see there's a web address for the legislation - beware runs to 115 pages ; and a contact email address for getting reliable answers to any questions you may have. Hope this helps.