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No More Limited Sale for Products with Provisional Licenses or Experimental Use Permits

MAF has considered the impracticality of enforcing the limited sale conditions on provisional licenses and experimental use permits. It has decided that it is inappropriate for products to be placed on the market until all the information has been assessed adequately, and it is not possible to monitor limited sale permits/licenses adequately. It considers that trials and research on products to gather registration information should be carried out in containment only.

Therefore, no limited sale permits or licenses will be issued after 31 July 1999.

All existing permits and licenses will continue with the same conditions until the expiry date specified in the permit or license.

The primary purpose of containment is security to ensure that:

• the product is not used outside that containment;

• at the end of the trial/research, any unused product is disposed of in a manner approved by MAF; and

• any produce from animals or plants treated or exposed is disposed of in a manner approved by MAF.

The details of the research are not relevant to provisional registration nor is the exact nature of the product or its manufacture. MAF will require only sufficient information to know the ingredients or range of ingredients (not formulation) and the general nature of the trial/research. However, it will require detailed information on how the security of the containment will be maintained.

MAF is preparing a standard for provisional registration that will be used after the ACVM Act commences, but that standard will also be applied to applications for experimental use permits and provisional licenses after 1 January 2000, if the ACVM Act has not commenced.

It is expected that the standard for provisional registration will be available for public comment by the end of July 1999.