Import Health Standard  
Issued under the Biosecurity Act 1993   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Biological Products  
BIOLOGIC.ALL  
[Document Date]  
 Import Health Standard : Biological Products    
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Ministry for Primary Industries   Page  1 of 22 
TITLE  
Import Health Standard : Biological Products   
COMMENCEMEN T 
This Import Health Standard  comes into force on  [Effective Date ]  
 
 
ISSUING AUTHORITY  
This Import Health Standard  is issued under section 24A of the Biosecurity Act 1993.  
 
Dated at Wellington , [Document Date]  
 
 
Vicki Melville  
(Acting) Manager , Import and Export Animals  
Ministry for Primary Industries  
(acting under dele gated authority of the Director -General)  
 
Contact for further information  
Ministry for Primary Industries (MPI)  
Agriculture & Investment Services  
Animal Imports  
PO Box 2526  
Wellington 6140  
 
Email: animal.imports@mpi.govt.nz  
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Contents  Page 
Introduction  3 
Part 1:  Requirements  5 
1.1 Application  5 
1.2 Incorporation by reference  5 
1.3 Definitions  5 
1.4 Requirements for clearance  5 
1.5 Requirements that apply before a biological product can be moved to a transitional facility  6 
1.6 Packaging and transport  6 
1.7 Documentation that must accompany goods  6 
Part 2:  Specified Requirements for Biological Products  8 
2.1 Biological products for therapeutic use on or in humans  8 
2.2 Biological products that can be cleared on entry to New Zealand  8 
2.3 Biological products for use within a trans itional facility  8 
Schedule 1 – Document History  9 
Schedule 2 – Definitions  10 
Schedule 3 – Biological products for therapeutic use on or in humans  12 
Schedule 4 – Biological products that can be cleared on entry to New Zealand  13 
Schedule 5 – Biological pr oducts for use within a transitional facility  20 
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Introduction  
This introduction  is not part of the  Import Health Standard  (IHS) , but is intended to indicate its general effect.  
Purpose  
This IHS specifies the minimum requirements that must be met when importing  biological products  into New 
Zealand . 
Background  
The Biosecurity Act 1993 (the Act) provides the legal basis for excluding, eradicating and effectively managing 
pests and unwanted organisms.  
Import health standards issued under the Act set out requirements to be met to effectively manage biosecurity 
risks associated with importing goods. They include requirements that must be met in the export ing country, 
during transit, and before biosecurity clearance can be given.  
Guidance boxes are included within this IHS for explanatory purposes. The guidance included in these boxes 
is for information only and has no legal effect.  
A guidance document also  accompanies this IHS providing information on how requirements may be met . 
Who should read this  Import Health Standard ? 
This IHS applies to importers of biological products . 
Why is this important?  
It is the importer’s responsibility to ensure the requirements of this IHS are met. Consignments that do not 
comply with the requirements of this IHS (and any other applicable IHS) may not be cleared for entry into New 
Zealand and/or further information may be sought from importers. Consignments that do not comply with the 
requirements of this IHS may be re -shipped or destroyed under the Act or tested/treated in accordance with 
this IHS prior to release or equivalence determined. Importers are liable for all associated expenses.  
The costs to MPI in per forming functions relating to the importation of biological products  will be recovered in 
accordance with the Act and any regulations made under the Act. All costs involved with documentation, 
transport, storage and obtaining a biosecurity clearance must  be covered by the importer or agent.  
Equivalence  
The Chief Technical Officer (CTO) may issue a direction under section 27(1)(d) of the Act that measures 
different from those set out in this IHS may be applied to effectively manage risks associated  with the 
importation of goods  to which this IHS applies .  
If an equivalent measure is approved, an import permit may be issued under section 24D(2) of the Act if the 
Director -General considers it appropriate to do so. The details of the CTO direction on e quivalence will be 
included as notes in the special conditions section of the permit to inform the inspector’s assessment of the 
commodity.  
MPI’s preference is that the exporting country’s Competent Authority makes equivalence requests. 
Equivalence request s can be lodged with animal.imports@mpi.govt.nz . Import Health Standard : Biological Products    
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Transitional facility  
Any containers not intact on arrival will be required to be made secure before the consignment is moved to a 
transitional facility. Any  material which has leaked from the container will be destroyed at the port of entry.  
Biological products may only proceed to a n appropriately approved transitional facility  if required by an import 
permit and authorised by an inspector. Such biological pr oducts must  proceed directly to the transitional 
facility named on the import permit.  
The documentation will be checked to ensure it meets all requirements set out in Part 1  and any specifi c 
requirements ( including veterinary certification) in Schedules 3 to 5 of this IHS.  
Biosecurity clearance  
A biosecurity clearance, under section 26 of the Act, may be issued when the biological products  meet all the 
requirements of this IHS  (and any other applicable IHS) , provided  the applicable requirements of section 27 in 
the Act are met.  
Products subject to a restricted import permit must remain in the transitional facility and will not be given 
biosecurity clearance  unless further treated to mitigate any risk . 
Inspection  
On ar rival, all documentation accompanying the consignment may be verified by an inspector.  
Document History  
Refer to Schedule 1.  
Other information  
This is not an exhaustive list of compliance requirements and it is the importer’s responsibility to be fami liar 
with and comply with all  relevant  New Zealand laws . 
Medicines Act 1981  
Medicines imported into New Zealand must comply with the requirements of the Medicines Act 1981 .  
Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997  
Agricultural compounds and veterinary medicines imported into New Zealand must comply with the 
requirements of the Agricultural Compounds and Veterinary Medicines Act 1997 . 
Import Health Standards  
Any other relevant IHSs must also be complied with before biosec urity clearance will be issued.  
 
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Part 1:  Requirements  
1.1 Application  
(1) This IHS applies to imports of biological products from any countr y into New Zealand.  
(2) For the purposes of this IHS, a biological product is defined as  a non-viable (not capable of living, 
replicating, reproducing or developing) product derived from  a living organism other than from a human 
being, and includes a sample of animal origin.   
(3) This I HS applies to b iological product s imported for one of the following purposes:  
a) Laboratory research, diagnostic and analytical purposes (including equipment calib ration and 
validation); or  
b) Animal product samples for evaluation and/or proficiency testing; or  
c) Environmental use; or   
d) Use in, or on, humans, animals and/or plants (e.g. medical, veterinary or horticultural use).  
 
Guidance  
 See Guidance Document  for more i nformation about :  
 the four eligible categories.  
 biological products derived from humans . 
1.2 Incorporation by reference  
(1) The following material is incorporated by reference in this IHS under section 142M of the Act:  
a) MPI Treatment Requirement: Approved Biosecurity Treatments, MPI -STD-ABTRT  
b) OIE list of FMD -free countries: http:// www.oie.int/animal -health -in-the-world/fmd -portal/country -
freedom/  
(2) Under section 142O(3) of the Act it is declared that section 142O(1) does not apply . That is, a notice 
under section 142O(2) of the Act is not required to be published before material that amends or 
replaces the standards, guideline or lists incorporated under clause 1.2(1) above has legal effect as 
part of this IHS . 
1.3 Definitions  
(1) For the  purposes of this IHS and the associated guidance , terms used that are defined in the Act have 
the meanings set out there. The Act is available at the following website: 
http://www.legislation.govt.nz/ . 
(2) See Schedule 2  for additional definitions that apply . 
1.4 Requirements for clearance  
(1) A biological product may only be granted biosecurity clearance if:  
a) It is a biological product described in Schedule 3, 4, or 5  and it meets the applicable 
requirements specified in th at Schedule.  
b) Any packaging for the biological product complies with clause 1. 6. 
c) The biological product is accompanied by an import permit  (where required by the applicable  
Schedule),  and the biological product co mplies with any conditions of that import permit.  Import Health Standard : Biological Products    
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d) The biological product is accompanied by  a veterinary certificate (where required by the 
applicable Schedule)  and the  veterinary certificate complies with  the requirements of clause 
1.7.1. 
e) The biological pr oduct is accompanied by  a manufacturer’s declaration (where required by the 
applicable Schedule) and the  declaration complies with clause 1.7 .2.  
(2) Any biological product that is not described in Schedule 3, 4, or 5 , but where the  biosecurity risks 
associate d with the biological product ha ve been assessed by MPI and concluded to  be managed 
effectively, must be accompanied by an import permit and meet the conditions of that permit before it is 
eligible to receive biosecurity clearance.  
 
Guidance  
 See Guidance Document  for more information about :  
 biological products and samples eligible for biosecurity clearance under another IHS.  
 ACVM  registered , approved or exempt  products . 
 biosecurity risk assessment.  
1.5 Requirements that apply before a biological product can be 
moved to a transitional facility  
(1) A biological product may only be moved to an appropriately approved transitional facility if the 
biological product is : 
a) Described in Schedule 5 and meets the requirements for import that are specified in that 
Schedule.  
b) Accompanied by an import permit  as required in Schedule 5  and meets any conditions of that 
import permit , including being moved only to the transitional facility named on the import permit.  
 
Guidance  
 See Guidance Document  for more information about biologic al products for use within a 
transitional facility.  
1.6 Packaging and t ransport  
(1) Packaging must be  clean, secure, free of any  organic  contaminants, and must be appropriate to 
effectively contain any potential biosecurity risks during transport.  
 
Guidance  
 See Guidance Document  for more information about packaging and transport.  
1.7 Documentation that must accompany goods  
(1) The consignment must arrive in New Zealand with the documentation that is specified in, and meets 
the requirements of , clauses 1 .7.1 and 1.7.2, as applicable,  below.  
(2) All documentation that is required to accompany  biological products  by Schedules 3, 4 or 5  must, 
unless otherwise stated:  
a) Be original  or be an elect ronic copy of the original document .  
b) Accompany the imported goods  and be securely attached to the outside of the external 
packaging . Import Health Standard : Biological Products    
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c) Be in English or have an English translation that is clear and legible.  
d) Where applicable, b e endorsed on every page by the Official Veterinarian with their original 
stamp, signature and date or be endorsed  in the space allocated and all pages have paper based 
alternative security features.  
 
Guidance  
 See Guidance Document  for more information about applying for an import permit.  
1.7.1 Veterinary certificate  
(1) If required by this IHS , a veterinary certificate from t he exporting country’s Official Veterinarian  is 
required . The veterinary certificate must include the following:  
a) A unique consignment identifier.  
b) The description, source species, and amount of product . 
c) Name and address of the importer (consignee) and expor ter (consignor).  
d) Name, signature and contact details of the Official Veterinarian.  
e) Certification and endorsement by the Official Veterinarian that the general requirements outlined 
in Part 1 of this IHS have been met.  
f) Certification and endorsement by the O fficial Veterinarian that the relevant  requirements outlined 
in the applicable  Schedule  of this IHS have been met .  
 
Guidance  
 See Guidance Document  for more information about equivalence . 
1.7.2 Declaration s 
 Manufacturer’s declaration  
(1) If required by this IHS , a manufacturer’s declaration  must accompany the consignment . The 
manufacturer’s declaration  must :  
a) Include any declarations  required by the applicable Schedule  of this IHS.  
b) Be prepared by the manufacturer on letterhead paper . 
c) Be signed and dated by the qua lity manager  of the manufacturer  or equivalent . 
 Certificate of irradiation  
(2) If required by this IHS, a certificate of irradiation must accompany the  consignment . The certificate of 
irradiation must:  
a) Include any declarations required by the applicable Schedule  of this IHS.  
b) Be prepared by the irradiation service provider on  letterhead paper .  
c) Be issued by an official government department or a recognised institution.  
d) Be signed and dated by the official government department or the quality manager (or 
equivalent) of the irradiation service provider or equivalent.  
Declaration for naked DNA, RNA, and/or nucleic acid; preserved/fixed whole animal or 
animal tissue  
(3) A declaration for nake d DNA, RNA, and/or nucleic acid and preserved/fixed whole animal or animal 
tissue  is a requirement of this IHS . This declaration must:  
a) Include an importer  declaration  confirming the requirements of IHS  have been met.  
b) Be prepared by the supplier  on letterhead paper of the appropriate organisation.  
c) Be signed and dated by the Head o f Department of the appropriate organisation  or equivalent  Import Health Standard : Biological Products    
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Part 2:  Specified Requirements for Biological Products  
2.1 Biological products for therapeutic use on or in humans  
(1) Biological products described in Schedule 3 can be cleared on entry to New Zealand provided that 
they meet the requirements specified in that Schedule.  
2.2 Biological products  that can be cleared on entry to New Zealand  
(1) The biological products  described in Schedule 4  can be cleared on entry to New Zeal and provided that 
they meet the requirements specified in Schedule  4.  
 
Guidance  
 See Guidance Document  for more information on biological products that can be cleared on entry 
to New Zealand . 
2.3 Biological products for use within a transitional facility  
(1) Biological products described in Schedule 5  cannot be imported into New Zealand unless they meet 
the specified requirements outlined in that Schedule . The biological products must be moved to an 
appropriately approved transitional facility  in accordance with t his IHS . 
 
Guidance  
 See Guidance Document  for more information on biological products for use within a transitional 
facility.  
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Schedule  1 – Document History  
Date First Issued  Title Shortcode  
TBA Import Health Standard: Biological Products  BIOLOGIC.ALL  
Date of Issued Amendments  Title Shortcode  
   
   
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Schedule 2 – Definitions  
ACVM Act 
Agricultural Compounds  and Veterinary Medicines Act 1997   
Appropriately Approved Transitional Facility  
An MPI -approved transitional facility that has been approved for the scope of the importation of the uncleared 
biological products.  
Chemically Synthesised  
Chemical synthesis, the construction of complex chemical compounds from simpler ones  
Commercially Manufactured and Packaged  
A product that has been manufactured in a commercial manner by a commercial enterprise and is packaged 
for retail trade in tamper -proof packaging.  
Competent Authority  
The Veterinary or other Governmental Authority of an OIE Member  that has the responsibility and 
competence for ensuring or supervising the implementation of animal health and welfare measures, 
international veterinary certification and other standards and recommendations in the OIE Code in the whole 
territory  of that OIE member . 
Director -General  
The chief executive of the Ministry for Primary Industries  or his/her delegate . 
Good Manufacturing Practice  
A Competent Authority -approved system aimed at ensuring medicinal products are consistently produced and 
controlled acc ording to quality standards appropriate to their intended use and as required by the product 
specification . 
General Import P ermit  
A permit issued by the Director -General of MPI pursuant to section 24D(2) of the Act  where the biosecurity 
risks associated wi th the product listed in the permit have been assessed by MPI and concluded to be 
managed effectively . 
Highly Purified  
Pure and free of any foreign, extraneous or objectionable elements.  
In-vitro  
Refers to a process or reaction carried out outside a living  organism (including, but not limited to, in a culture 
dish or test tube).  
In-vivo  
Refers to a process or reaction  (such as a study or experiment)  carried out in side a living organism.  
Medicine  
Medicine for human use, as defined in the Medicines Act 1981 . Import Health Standard : Biological Products    
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Microorganism  
A microscopic organism including protozoa, fungi, bacteria, viruses, unicellular algae and prions.  
MPI 
Ministry for Primary Industries, New Zealand.  
Official Veterinarian  
A veterinarian authorised by the Competent Authority of the relevant  OIE member  to perform certain 
designated official tasks associated with animal health and/or public health and inspections of commodities 
and, when appropriate, to certify in conformity with the provisions of the OIE Code Chapter for certification 
procedu res. 
OIE 
The World Organisation for Animal Health.  
OIE Code  
The OIE Terrestrial Animal Health Code as found on the OIE website.  
Restricted Import Permit  
A permit issued by the Director -General of MPI pursuant to section 24D(2) of the Act where : 
 the biosecu rity risks associated with the product  listed in the permit have been  assessed by MPI ; 
 MPI has  concluded  the product  pose s a risk to New Zealand ; and  
 MPI has concluded that the risk can be mitigated by requiring the product to be held and/or used 
only in an appropriate approved transitional facility.  
Sample  
A small part intended as a representative of the whole.  
Sterilised  
A process  has been applied to  completely remove viable microorganisms or render  the microorganisms non -
viable.  
Therapeutic Use 
Applies o nly to humans and h as the same meaning as therapeutic  purpose  as defined in section 4 of the 
Medicines Act 1981, being : 
…, unless the context otherwise requires, therapeutic purpose  means any of the following purposes, 
or a purpose in connection with any of the following purposes:  
a) preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, 
ailment, defect, or injury; or  
b) influencing, inhibiting, or modifying a physiological process; or  
c) testing the susceptibility of persons to a disease or ailment; or  
d) influencing, controlling, or preventing conception; or  
e) testing for pregnancy; or  
f) investigating, replacing, or modifying parts of the human anatomy.  
Veterinary Certificate  
A certificate, issued in conformity with the provisions of the OIE Code Chapter for certification procedures, 
describing the animal health and/or public health requirements which are fulfilled by the exported 
commodities.  Import Health Standard : Biological Products    
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Schedule 3 – Biological products for therapeutic use on or in humans  
NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
Biological products for therapeutic use in or on humans.  (1) If the products are commercially manufactured and packaged, a declaration on the shipping 
documents is required that confirms the products are intended for human use; or 
(2) If the products are not commercially manufactured and/or packaged  but are manufactured  in a good 
manufacturing practice approved facility , a signed and dated manufacturer’s declaration  is required 
that complies with clause 1.7.2 of this IHS and confirms:  
a) The products are intended for human use; and  
b) The batch numbers of the imported commodity.  
(3) For surgical implants, packaging must also identify the product is sterile.  
 
 
 
 
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Schedule 4 – Biological products that can be cleared on entry to New Zealand  
Guidance  
 See Guidance Document  for more information about  the: 
 biosecurity  requirements for agricultural compounds and veterinary medicines.  
 recommended format for model manufacturer declaration s. 
 recommended format for veterinary certificate s. 
 recommended declaration to use if clearance is sought under Schedule 4 . 
 supporting  documentation (section 4.4  of the Guidance Document ) for the t ested, filtered and irradiated Australian -origin foetal bovine serum, calf serum and bovine serum 
from Australia .  
 
NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
Agricultural compounds  (as defined in the ACVM  Act), excluding 
specified serological products , and agricultural compounds intended 
for potency testing  in animals . (1) A specific biosecurity assessment  of the commodity  is required to be undertaken by MPI  prior to 
ACVM Act authorisation . If the biosecurity risk assessment concludes the risk is effectively managed 
a biosecurity approval letter will be issued; and  
(2) The agricultural compound  must be:  
a) Listed on the ACVM Register  with the ACVM registration number printed on the product label ; 
or 
b) Accompanied by   special circumstances approval granted by the Director -General under 
section  8C of the ACVM A ct; or 
c) Accompanied  by  provisional registration granted by the Director -General under s ection  27 of 
the ACVM Act ; or 
d) Accompanied by  research approval for special use granted by the Director -General under 
section  8C(1) of the ACVM Act  1997 . 
Amino acids  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Is for laboratory  use.  Import Health Standard : Biological Products    
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NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
Antibiotics and antimicrobials  A signed and dated manufacturer’s declaration  is required  that complies with clause 1.7.2 of this IHS and 
confirm s the commodity:  
(1) Is commercially manufactured and packaged;  and 
(2) Is for laboratory use ; and  
(3) Is not for use production of products destined for use in and/or on  animals or plants . 
Highly purified, sterilised or chemically synthesised laboratory 
reagents or highly purified sterile products produced from egg  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the commodity : 
(1) Is commercially manufactured and packaged; and 
(2) Is not for use in the production of products destined for use in and/or on animals ; and 
a) Has been chemically synthesised; or   
b) Is highly purified and sterilised . 
Highly purified and/or sterilised products derived from blood for 
laboratory use  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and  
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Has been sterilised or purified to completely remove viable microorganisms or render any 
microorganisms non -viable; and 
(3) Is not for use in the production of products destined for use in  and/or on  animals.  
Irradiated whole animal specimens  Certificate of ir radiation  issued by the irradiation service provider  is required that complies with clause 1.7. 2 
of this IHS and  confirms  the whole animal specimen has been : 
(1) Subjected to a minimum dose  of 5 mrad (50kGy); and 
(2) Sealed in a hermetically  sealed container  that is clearly linked to the certificate of irradiation.  
Laboratory culture media containing biological products of animal 
origin  (1) Must be commercially manufactured and packaged; and   
(2) Must be labelled for in-vitro use only; and  
(3) Either:  Import Health Standard : Biological Products    
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NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
a) The packaging identifies the media as sterile; or 
b) A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of 
this IHS and confirms the media:  
i) Has been sterilised to completely remove viable microorganisms or render any 
microorganisms non -viable; and 
ii) Is not for use in the production of products destined for use in  and/or on  animals as 
veterinary medicines ; and 
iii) The manufacturer’s declaration is li nked to the batch number(s) of the media being 
imported.  
Laboratory reagents and products produced from animal tissue, 
excluding  bloods, serum and/or serum proteins  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Is for laboratory use; and 
(3) Is highly purified or sterilised.  
Microscope slides of animal tissue, bacteria, and protozoa  (1) Must be f ixed onto gl ass microscope slides; and 
(2) Must be u nder glass coverslips.  
Naked DNA,  RNA, and /or nucleic acid  A signed and dated declaration  is required that complies with clause 1.7.2 of this IHS and confirms the  
DNA, and/or RNA, and/or nucleic acid is naked (not contained within a vector) and purified.  
Non-sterile laboratory culture media, not containing any ingredients of 
animal origin  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the media:  
(1) Is commercially manufactured and packaged; and 
(2) Does not contain any ingredients of animal origin, including blood, whole serum, animal proteins, 
and/or animal tissues; and 
(3) Is not for use in the production of products destined for use in and/or on animals as veterinary 
medicines.  Import Health Standard : Biological Products    
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NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
Preserved/fixed specimens of animal tissues  Preservation method  1:  
Preserved with a minimum of:  
(1) 10% liquid formalin; or 
(2) 70% alcohol  Preservation method  2:  
Fixed in 2 to 4% glutaraldehyde for 
tissues:  
(1) Less than 2mm thick for 
electron microscope imaging; 
or 
(2) Larger samples by 
intravascular active perfusion  Preservation method  3:  
Fixed in glyoxal if equal to, or 
less than, 2mm thick.  
A signed and dated declaration  is required that states the preservation method used.  
Preserved  whole animal specimens , specimens of parasites , and 
animal faeces  specimens  (1) Preserved with a minimum of:  
a) 10% liquid formalin; or  
b) 70% alcohol  
(2) A signed and dated declaration  is required that s tates the preservation method used.  
Purified products derived from microorganisms  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and  
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Is for laboratory use.  
Restriction enzymes, defined as an enzyme which cleaves DNA at 
specific sites to allow the splicing of DNA from one source (or species) 
into another  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Is for laboratory use.  
Tested, filtered and irradiated Australian -origin foetal bovine serum, 
calf serum and bovine serum from Australia  (1) Commercially manufactured, packaged, and sealed; and 
(2) A signed and dated manufacturer’s declaration is required that complies with clause 1.7.2 of this IHS 
and states:  Import Health Standard : Biological Products    
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NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
I, ......................................., being the manager of the factory where the te sted, filtered and irradiated foetal 
bovine serum, calf serum and bovine serum identified in this manufacturer’s declaration  has been 
processed, certify that:  
a) This product was manufactured using processes which comply with an industry accepted code 
of good  manufacturing practice and using a quality system equivalent to the current version of 
ISO 9001 that records details of the product description, the origin and nature of each batch of 
product, the manufacturing process, the quality control testing carried  out and packaging and 
consignment details.  
b) Either (strikethrough or delete non -applicable statement) : 
i) This product has been filtered to 0.22 micron  or less and has been irradiated with a 
single or multiple irradiation dose totalling 5 mrad (50 kGy) ; or  
ii) This product has been subject to triple 0.1 micron membrane filtration and has been 
irradiated with a single or multiple irradiation dose totalling 2.5 mrad (25 kGy),  and 
iii) The product has been tested and found free of mycoplasma. It has also been tested and  
found free from bovine virus diarrhoea, infectious bovine rhino tracheitis, bluetongue and 
parainfluenza -3 using the methods described in the relevant Australian standard or, in its 
absence, described by relevant OIE guidelines.  
c) The products were derived from cattle born and reared in Australia  or New Zealand . In the 
case of foetal bovine serum, it was obtained from blood collected from foetuses whose dams 
were born and raised in Australia  or New Zealand . 
d) Either (strikethrough or delete non -applicable stat ement) : 
i) Product sourced from abattoirs was derived from animals which passed ante -mortem 
and post -mortem inspection and were processed in premises under the supervision of 
the controlling authority and in accordance with the regulations of Australia  or New  
Zealand ; or 
ii) Product sourced from donor herds was derived from herds that were under veterinary 
supervision and the animals were clinically free from infectious or contagious diseases ; 
and Import Health Standard : Biological Products    
 Draft for Consultation  [Document Date]  
Ministry for Primary Industries   Page  18 of 22 
NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
(3) A signed and dated veterinary certificate  is required that complies  with clause 1.7.1 of this IHS and 
states that after due enquiry, there is no reason to doubt the veracity of the Manufacturer’s 
Declaration.  
Test kits that do not contain viable microorganisms  A signed and dated manufacturer’s declaration  is required that complies with clause 1.7.2 of this IHS and 
confirms the commodity:  
(1) Is commercially manufactured and packaged; and 
(2) Does not contain viable microorganisms; and 
(3) Is for laboratory use.  
 
 
GENERAL  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Requirements  
Agricultural compounds that contain imported biological ingredients 
and which are exempt  from ACVM Act registration.  A specific biosecurity assessment of the commodity is required to be undertaken by MPI , unless the imported 
biological ingredients are listed in the Negligible Risk Ingredient Schedule included in the Biosecurity 
Approval of Imported Agricultural Compounds and Veterinary Medicin es – ACVM Guidance  document . If the 
biosecurity risk assessment concludes the risk is effectively managed, a general import permit is required 
unless the product meets the requirements under an existing import health standard.  
Antisera and antibodies derived from laboratory -raised guinea pigs, 
hamsters, mice, rabbits, and rats  (1) Must be c ommercially manufactured and packaged; and 
(2) A specific biosecurity risk assessment of the commodity is required to be undertaken by MPI ; and 
(3) If the biosecurity risk assessment concludes the risk is effectively managed, a general import permit is 
required.  
Culture media for use in the manufacture of agriculture compounds  
(as defined under the ACVM Act  and including veterinary medicines 
and animal feed ) A specific biosecurity assessment is required to be undertaken by MPI.  If the biosecurity assessment 
concludes the risk is effectively managed, a general import permit is required.  Import Health Standard : Biological Products    
 Draft for Consultation  [Document Date]  
Ministry for Primary Industries   Page  19 of 22 
GENERAL  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Requirements  
Biological products not specifically listed but where the biosecurity 
risks associated with the biological products have been assessed by 
MPI and concluded to be managed effectively.  (1) Commercially manufactured and packaged; and  
(2) A specific biosecurity risk assessment is required to be undertaken by MPI ; and 
(3) If the biosecurity risk assessment concludes the risk is effectively managed, a general import permit is 
required.  
Biological ingredients imported as raw materials for formulation into 
agricultural compounds in New Zealand . A specific biosecurity assessment of the commodity is required to be undertaken by MPI, unless the imported 
biological ingredients are listed in the Negligible Risk Ingredient Schedule included in the Biosecurity 
Approval of Imported Agricultural Compounds and Veterinary Medicines – ACVM Guidance  document . If the 
biosecurity risk assessment concludes the risk is effectively managed, a general import permit  is required . 
 Import Health Standard : Biological Products    
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Ministry for Primary Industries   Page  20 of 22 
Schedule 5 – Biological products for use within a transitional facility  
Guidance  
 See Guidance Document  for more information about : 
 commercially manufactured and packaged risk goods.  
 non-commercially manufactured and/or packaged laboratory un -sterilised/un -purified products . 
 samples for analytical testing . 
 the recommended format for model manufacturer declaration s. 
 the recommended format for veterinary certificate s. 
 supporting documentation (section 4.4  of the Guidance Document ) for the Australian -origin foetal bovine serum, c alf serum or bovine serum for further processing . 
 See clause 2. 3(8) of MPI-STD-BIOLOGICAL  for more information about in vivo use of biological products of animal origin.  
 
RESTRICTED  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Importation requirements  Clearance requirements  
Animal samples for testing  (1) Must be f rom clinically healthy animals; and 
(2) Must be used f or chemical and nutritional analysis; and 
(3) Must be moved to an appropriately approved transitional 
facility.  Will only be eligible for clearance if the commodity is further processed 
in accordance with the requirements in the relevant transitional facility 
standard/operating manual or MPI-STD-ABRT  so that after 
processing, it is no longer considered by MPI to be a risk good . 
Australian -origin foetal bovine 
serum, calf serum or bovine serum 
for further processing  (1) Must be c ommercially manufactured, packaged, and sealed; 
and 
(2) A signed and dated manufacturer’s declaration  is required  that 
complies with clause 1.7.2 of this IHS and states:  
I, ......................................., being the manager of the factory 
where foetal bovine serum, calf serum and bovine serum 
identified in this manufacturer’s declaration  has been 
processed, certify  that: 
a) This product was manufactured using processes which 
comply with an industry accepted code of good 
manufacturing practice and using a quality system (1) Filtered to 0.22 micron  or less;  and 
(2) Irradiated with a single or multiple irradiation dose totalling 5 
mrad (50kGy)  Import Health Standard : Biological Products    
 Draft for Consultation  [Document Date]  
Ministry for Primary Industries   Page  21 of 22 
RESTRICTED  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Importation requirements  Clearance requirements  
equivalent to the current version of ISO 9001 that records 
details of the product description, the or igin and nature of 
each batch of product, the manufacturing process, the 
quality control testing carried out and packaging and 
consignment details.  
b) The products were derived from cattle born and reared in 
Australia  or New Zealand . In the case of foetal bo vine 
serum, it was obtained from blood collected from foetuses 
whose dams were born and raised in Australia  or New 
Zealand .  
c) Either  (strikethrough or delete non -applicable statement) : 
i) Product sourced from abattoirs was derived from 
animals which passed ante-mortem and post -
mortem inspection and were processed in 
premises under the supervision of the controlling 
authority and in accordance with the regulations of 
Australia  or New Zealand ; or 
ii) Product sourced from donor herds was derived 
from herds that wer e under veterinary supervision 
and the animals were clinically free from infectious 
or contagious diseases ; and  
(3) A signed and dated veterinary certificate  is required that 
complies with clause 1.7.1 of this IHS and states that after due 
enquiry, there is no  reason to doubt the veracity of the 
Manufacturer’s Declaration.  
Biological products of animal origin 
not listed specifically under 
Schedul e 3 or Schedule 4 . A specific biosecurity assessment is required to be undertaken by 
MPI t o determine whether the biosecurity risk associated with the 
commodity can be  effectively mitigated by moving the product to an 
appropriately approved transitional facility.  Will only be eligible for clearance if the commodity is further processed 
in accordance with the requirements in the relevant transitional facility 
standard/operating manual or MPI-STD-ABRT  so that after 
processing, it is no longer considered by MPI to be a risk good .  Import Health Standard : Biological Products    
 Draft for Consultation  [Document Date]  
Ministry for Primary Industries   Page  22 of 22 
RESTRICTED  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Importation requirements  Clearance requirements  
If the biosecurity assessment concludes the risk can be mitigated by 
moving the product to an appropriately approved transitional facility, a  
restricted import permit is required . 
Products for laboratory use and/or 
catalogued items comprised of 
animal products that are not 
specifically listed under Schedule 
3 or Schedule 4.  (1) Commercially manufactured and packaged;  and 
(2) Must be moved to an appropriately approved transitional 
facility.  Will only be eligible for clearance if the commodity is further processed 
in accordance with the requirements in the relevant transitional facility 
standard/operating manual or MPI-STD-ABRT  so that after 
processing, it is no longer c onsidered by MPI to be a risk good .  
Un-sterilised/un -purified laboratory 
products  (1) Non-commercially manufactured and/or packaged; and 
(2) Must be moved to an appropriately approved transitional 
facility.  Will only be eligible for clearance if the commodity is further processed 
in accordance with the requirements in the relevant transitional facility 
standard/operating manual or MPI-STD-ABRT  so that after 
processing, it is no longer considered by MPI to be a risk good .