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NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/
AgVetLink February 2005
Manufacturing register updated
The register of manufacturers of veterinary medicines for which approval of good manufacturing practice (GMP) has been provided has been updated on the website ( http://www.nzfsa.govt.nz/acvm/registers-lists/manu-ar-approved.htm ). It would be appreciated if you would check and notify us of any errors or omissions.
The main change to the register has occurred as a result of the implementation of the ACVM Act and our continuing efforts to reduce the costs of compliance.
Previously all registered veterinary products could be produced only by GMP approved manufacturers. Now some veterinary medicines (generally in the oral nutritional category) still require registration but are considered to be in a lesser risk category. These products are assessed and defined as ‘specified requirements products’ (SRPs).
It has been determined that the appropriate level of regulatory control of SRPs can be achieved by assessment of less data than that required for pharmaceutical or biologically effective products, and that GMP assessment of manufacturers producing only SRPs is not required for their registration. As a result, manufacturers of SRPs have been removed from the register.
New category
A new category, manufacturers of vertebrate toxic agents, has been added to the register. Previously, vertebrate pest control products were regulated under the Pesticides Act and no GMP assessments were carried out of manufacturers of pesticides.
With the implementation of the ACVM Act it has been necessary to reclassify these products as vertebrate toxic agents. Because they are applied to animals, the animal welfare and residue risks must be managed.
Therefore, it has been determined that GMP approval is necessary for these manufacturers and they are now in the inspection programme to facilitate regulatory control of these products from manufacture to end use.
Categories of Manufacture
The categories of manufacture now being used by the ACVM Group are:
Cat 1 |
(a) Immunobiologicals |
(b) Sterile veterinary preparations | |
Cat 2 |
Non-sterile veterinary medicines |
Cat 3 |
Ectoparasiticides (large volume) |
Cat 4 |
Plant compounds |
Cat 5 |
Agricultural compounds and veterinary medicines in Schedule 3 |
Cat 6 |
Repackers/Labellers |
Cat 7
|
(a) Contract testing |
(b) Contract sterilising organizations | |
Cat 8 |
Registrants/Distributors of HGPs |
Cat 9 |
Vertebrate toxic agents |
New Zealand Food Safety Authority
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PO Box 2835
Wellington
NEW ZEALAND
Phone: +64 4 894 2500
Fax: +64 4 894 2501
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