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: Silirum
Active Ingredient and Concentration: Mycobacterium paratuberculosis 2.5mg/1ml dose
General Use Claim: Silirum Vaccine is indicated as an aid in the control Bovine Johne’s Disease (BJD or Paratuberculosis) in cattle, via active immunisation against Mycobacterium paratuberculosis.
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.
(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:
Pfizer New Zealand, Level Three, Pfizer House, 14 Normanby Road, Mt Eden (P.O. Box 3998), Auckland.
Dated at Wellington this 19th day of December 2005.
MAREE ZINZLEY, Programme Manager (ACVM & Non-Food Products) (acting under delegated authority).