Glen Bradbury, Manager, (ACVM Appraisal and Programmes), ACVM Group of the Ministry of Agriculture and Forestry (MAF), acting under delegated authority from the Director-General of MAF, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 ("the Act"), that a decision has been made under section 29(1) of the Act 1997, to reassess the following registered trade name products:
Trade Name: PregSure BVD
Reference: A009982
Active Ingredient:
Contains inactivated Bovine Viral Diarrhoea (BVD) Type 1 virus, cytopathic strain 5960
Formulation Type:
Oily solution or suspension (oil-in-water emulsion)
General Use Claims:
For the active immunisation of cattle from 3 months of age to protect against infection with Bovine
Viral Diarrhoea Virus (BVDV). To prevent disease associated with BVDV transplacental infection and the birth of persistently infected calves. To improve herd pregnancy rates and reduce fertility losses in the face of challenge with BVDV.
Reason for Reassessment: The decision to reassess has been determined based on the submission of a large number of serious Adverse Event Reports involving the use of this product, and new information regarding the concurrent use of long-acting barium selenate injectable products and Bovine Viral Diarrhoea (BVD) vaccines in cattle. In addition, due to risks associated with use of this product and the development of Bovine Neonatal Pancytopenia (BNP), registration of this product has been suspended under section 31 of the Act pending the outcome of the reassessment.
Any person may make a written submission to the
director-general concerning this reassessment.
Under sections 16 and 17 of the Act, a written submission:
(a) must state in full the reasons for making the submission; and
(b) may state any decision sought on the reassessment; and
(c) must be received by the director-general no later than 30 working days after the date of notification in this New Zealand Gazette.
A copy of every submission will be forwarded to the applicant for its information.
The following address is:
(a) where submissions on these reassessments are to be sent; and
(b) where requests for copies of the public information relating to these reassessments can be sent; and
(c) where public information relating to these reassessments can be viewed; and
(d) the director-general’s address for service.
ACVM Group, Ministry of Agriculture and
Forestry, Pastoral House, Level 11, 25 The
Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
Dated at Wellington this 2nd day of September 2011.
GLEN BRADBURY, Manager (ACVM Appraisals and Programmes), Ministry of Agriculture and Forestry (acting under delegated authority).