Pursuant to section 14 (1) of the Agricultural Compounds and Veterinary Medicines Act 1997, the Director-General of the Ministry of Agriculture and Forestry hereby gives notice that the following application has been made to register a trade name product under section 9 (1) of the Agricultural Compounds and Veterinary Medicines Act 1997:
Trade Name: Aftupor DEO
Reference: A009702
Active Ingredient and Concentration: 1 – 15µg 146S antigen per 1.0mL for each strain included (0.001 – 0.15g/L).
The quantity of antigen incorporated in the vaccine depends on the virus strain. Active ingredient content is declared
in terms of potency of each type or subtype of at least six or more PD50 and also based on a preinactivation titre of
at least 106 TCID50. Potency will be demonstrated by a log10SN50 titre of at least 1.42 for each strain. The vaccine may contain one strain or several.
General Use Claim: Inactivated, oil adjuvant, Foot and Mouth Disease vaccine for ruminants and pigs.
Any person may make a written submission to the Director-General, under section 17 of the Agricultural Compounds and Veterinary Medicines Act 1997, concerning any application notified above.
Such submissions:
(a) must state in full the reasons for making the submission;
(b) may state any decision sought on that application;
(c) must be received by the Director-General no later than 30 working days after the date of notification in the
New Zealand Gazette; and
(d) should be forwarded to the address given below.
A copy of every submission will be forwarded to the applicant for their information.
The address below is:
(a) where submissions and requests for copies of the public information relating to the application can be sent;
(b) where the public information relating to the application 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.
The applicant’s address for service is:
Biosecurity New Zealand, Pastoral House, Fourteenth Floor, 25 The Terrace (P.O. Box 2526), Wellington.
Dated at Wellington this 20th day of April 2006.
MAREE ZINZLEY, Programme Manager (ACVM and Non-Food Products) (acting under delegated authority).