Notice Title

Notice of Application to Reassess Trade Name Products (Notice No. 1450)

Pursuant to section 29 (1) (a) of the Agricultural Compounds and Veterinary Medicines Act 1997, the Director-General
of the Ministry of Agriculture and Forestry hereby gives notice that reassessments are to be undertaken on trade name products registered, under section 21 of the Agricultural Compounds and Veterinary Medicines Act 1997, that contain one or more of the following active ingredients:
Amoxycillin
Ampicillin
Apramycin sulphate
Bacitracin
Carbadox
Carnidazole
Cefadroxil monohydrate
Cefquinome
Ceftiofur
Cefuroxime sodium
Cephalexin
Cephalonium
Cephaprin benzathine
Chlortetracycline
Clavulonic acid
Clindamycin hydrochloride
Cloxacillin
Dicloxacillin
Difloxacin hydrochloride
Dihydrostreptomycin
Dimetridazole
Doxycycline
Enrofloxacin
Erythromycin
Florfenicol
Framycetin sulphate
Furazolidone
Fusidic acid hemi hydrate
Gentamicin
Kanamycin
Lincomycin hydrochloride
Marbofloxacin
Metronidazole
Nafcillin
Neomycin sulphate
Nitrofurazone
Novobiocin
Oleandomycin
Orbifloxacin
Oxytetracycline
Penethamate hydriodide
Penicillin
Pirlimycin hydrochloride
Polymixin
Polymyxin b sulphate
Spectinomycin
Spiramycin
Streptomycin
Sulfadiazine
Sulphadimethoxine
Sulphaguanidine
Sulphamerazine
Sulphamethazine
Sulphamethoxazole
Sulphamethoxoypyridazine
Sulphanilamide
Sulphapyridine
Sulphaquinoxaline
Sulphathiazol
Sulphisoxazole
Tetracyline hydrochloride
Tiamulin hydrogen fumarate
Tilmicosin
Trimethoprim
Tylosin
Virginiamycin
The Register of trade name products may be found at:
http://www.nzfsa.govt.nz/acvm/registers-lists/acvm-register/index.htm
The Register lists the active ingredients included in each trade name product and may be searched by any of the above-named active ingredients.
The reassessments will review the new information that indicates that advertising antibiotic products to end users is counter productive to the management of antibiotic resistance.
If it is determined that advertising is counter productive,
a condition prohibiting the advertising and promotion of products containing these active ingredients to any person other than a veterinarian or an approved trader is proposed.
Any person may make a written submission to the Director?General, under section 17 of the Agricultural Compounds and Veterinary Medicines Act 1997, concerning the reassessment.
Such submissions:
(a) must state in full the reasons for making the submission;
(b) may state any decision sought on that reassessment;
(c) must be received by the Director-General no later than 30 working days after the date of notification in this New Zealand Gazette; and
(d) should be forwarded to the address given below.
A copy of every submission will be forwarded to the registrant for its information.
The address below is:
(a) where submissions and requests for copies of the public information relating to the reassessment can be sent;
(b) where the public information relating to the reassessment can be viewed; and
(c) the Director-General’s address for service:
ACVM Group, New Zealand Food Safety Authority, Ministry of Agriculture and Forestry, 68-86 Jervois Quay (P.O. Box 2835), Wellington.
Dated at Wellington this 8th day of September 2005.
MAREE ZINZLEY, Programme Manager (Operations) (acting under delegated authority).