- Print Friendly - Help

Experimental Use Permits and Provisional Licenses

 In the July issue of AgVetLink the ACVM Group advised that the process of issuing experimental use permits and provisional license was going to change. A number of people misunderstood MAF’s intentions. They expressed concern that all experimental use permits and provisional licenses would be revoked and no permits or provisional licenses would be issued. This is not the case.

Experimental use permits and provisional licenses will continue to be issued. If the appropriate and relevant residue information is provided, a permit/license may even include an approval to sell, under specified conditions, the produce from animals or plants used in the research/trials. However, the permit/license will not include an approval to sell the pesticide or animal remedy product. The product will have to be fully registered/licensed before it can be sold.

A product may already be registered/licensed but an experimental use permit/provisional license is needed to gather data to support a new use or other change. The research/trials may be allowed but the product may not be advertised or sold for that new use or change until it is fully registered/licensed. However, the product can continue to be sold for the existing approved uses. In effect, experimental use permits for limited sale (EUP-LS) for pesticides and provisional licenses with limited sale (provisional 3 licenses) for animal remedies are being phased out.

All current permits and licenses will remain valid until the expiry date that is specified on the permit/license. However, any changes to existing permits/provisional licenses that are required will have to be the subject of a new application. A new application must include the information specified in the ACVM - Standard for Provisional Registrations. The information requirements focus on security to ensure that the product is not used other than for the approved research and the produce from animals and plants treated is not incorporated into human or animal food.

New permits and provisional licenses will have expiry dates applied to reflect the time needed to complete the research/ trials specified in the application. This may not be the full time presently allowed (i.e. two years for animal remedies and three years for pesticides). The quantity of product allowed will be limited to what is necessary and sufficient to carry out the research/trial specified.

The research/trial site(s) will have to be specified in the application. Where this is not practical the applicant will have to specify the mechanism by which sites will be identified and contractual arrangements made to keep the product secure on each site as it is identified.

These modifications have already been made under the Animal Remedies and Pesticides Acts and will be the same when the ACVM Act commences. It must be noted that, after the ACVM Act and Hazardous Substances and New Organisms Act commence, an agricultural compound or veterinary medicine that is also a hazardous substance will need an approval from the Environmental Risk Management Authority as well as ACVM provisional registration.