Import Health Standard  
Issued under the Biosecurity Act 1993   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Biological Products  
BIOLOGIC.ALL  
17 December 2021  
 Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  1 of 25 
TITLE  
Import Health Standard : Biological Products  
COMMENCEMENT  
This Import Health Standard  comes into force on  17 December 2021   
REVOCATION 
This Import Health Standard revokes and replaces the following:  
a) Import Health Standard for Biological Products  (including samples) , BIOPRODIC.ALL , dated 05 
November 2015  
b) Import Health Standard for Nonviable Animal Specimens , INESPEIC.ALL , dated 11 May 2004  
c) Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and 
Bovine Serum from Australia , BOVFBSIC.AUS , dated  12 March 2001  
d) Import Health Standard for Foetal Bovine Serum, Calf Serum and Bovine Serum for Further Processing from Australia , BOVSFPIC.AUS , dated  08 May 2001  
e) Import Health Standard for the Importation into New Zealand of Surgical Catgut from A ll 
Countries , SURCATIC.ALL . dated 5 July 2004  
ISSUING AUTHORITY 
This Import H ealth Standard  is issued under section 24A of the Biosecurity Act 1993.  
 
Dated at Wellington , 17 December 2021  
 
 
Vicki Melville  
Manager , Animal Health  
Ministry for Primary Industries  
(acting under dele gated authority of the Director -General)  
 Contact for further information  
Ministry for Primary Industries (MPI)  
Biosecurity New Zealand  
Animal Imports  
PO Box 2526  
Wellington 6140  
 
Email: animal.imports@mpi.govt.nz
 
 
 
 
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Contents  Page 
Introduction 3 
Part 1:  Requirements  6 
1.1 Application  6 
1.2 Incorporation by reference  6 
1.3 Definitions  6 
1.4 Requirements for clearance  7 
1.5 Requirements that apply before a biological product can be moved to a transitional facility  7 
1.6 Packaging and transport  7 
1.7 Documentation that must accompany goods  8 
1.8 Transitional arrangements for importers with a valid import permit issued under the Import 
Health Standard for Biological Products (including samples), BIOPRODIC.ALL  9 
Part 2:  Specified Requirements for Biological Products  10 
2.1 Biological products for therapeutic use on or in humans  10 
2.2 Biological products that can be cleared on entry to New Zealand  10 
2.3 Biological products for use within a transitional facility  10 
Schedule 1 – Document History  11 
Schedule 2 – Definitions  12 
Schedule 3 – Biological products for therapeutic use on or in humans  15 
Schedule 4 – Biological products that can be cleared on entr y to New Zealand  16 
Schedule 5 – Biological products for use within a transitional facility  23 
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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 or ganisms.  
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 exporting country, 
during transit, and before bi osecurity 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 requireme nts 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 performing functions relating to th e 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 a gent.  
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 wh ich 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 equivalence 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 requests 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 products 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 arrival, 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  familiar 
with and comply with all  relevant  New Zealand laws . 
Medicines Act 1981  
Medicines  and medical devices  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.  
Trade Single Window (TSW)  and Customs clearance 
All goods imported into New Zealand need to be cleared by the New Zealand Customs Ser vice (Customs) 
and the Ministry for Primary Industries (MPI). This is achieved by lodging required documentation in through 
the Trade Single Window (TSW) portal.  Import Health Standard: Biological Products    
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For more information about TSW please visit https://www.customs.govt.nz/business/trade -single- window/  
 
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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, including a sample of animal origin and non -viable products derived from 
microorganisms.   
(3) This IHS does not apply to biological products derived from plants.  
(4) 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 calibration 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 G uidance D ocument  for more information about:  
− the four eligible categories  (section 5 .5 of guidance) . 
− biological products derived from humans  (section 5.6 of guidance) . 
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: Foot and mouth disease -  OIE -  World Organisation for Animal 
Health  
c) OIE Terres trial Animal Health Code . 
(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, gui deline or lists incorporated under clause 1.2(1) above has legal effect as 
part of this IHS . 
 
Guidance  
• Incorporation by reference means that standards, guidelines or lists are incorporated into the IHS 
and they form part of the requirements  
 
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 . Import Health Standard: Biological Products    
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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 complies with any conditions of that import permit.  
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 c lause 
1.7.1.  
e) The biological product 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 t he biosecurity risks 
associated 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 clear ance.  
 
Guidance  
• See Guidance Document  for more information about :  
− biological products and samples eligible for biosecurity clearance under another IHS  
(section 6 of guidance) . 
− Products r egistered , approved or exempt  under the ACVM Act  (section 7.2 of guidance) . 
− biosecurity risk assessment  (section 7.3 of guidance) . 
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 re quired 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 biological products for use within a 
transit ional facility  (section 7.4 of guidance) . 
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  (section 5.7 of 
guidance) . Import Health Standard: Biological Products    
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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 by this clause 1. 7 to accompany biological products  must, unless 
otherwise stated:  
a) Be in English or have an English translation that is clear and legible.  
b) Be original.  
(3) Documentation that is in a paper format must, unless otherwise stated, be endorsed on every page by the Official Veter inarian with their original stamp, signature and date or be endorsed in the space 
allocated and all pages have paper based alternative security features.  
(4) Documentation that is in an electronic format must, unless otherwise stated, be transmitted directly 
from the Competent Authority of the exporting country to MPI, using an electronic system approved by 
MPI for that purpose.  
 
Guidance  
• See Guidance Document  for more information about applying for an import permit  (section 5.8 of 
guidance) . 
1.7.1 Veterinary certi ficate  
(1) If required by this IHS , a veterinary certificate from the 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 exporter (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 Official Veterinarian that the relevant  requirements outlined 
in either  Schedule  4 (biosecurity clearance) or Schedule 5 (direction to a transitional facility)  of 
this IHS have been me t.  
 
Guidance  
• See Guidance Document  for more information about equivalence  (section 5.1 of guidance) . 
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) Include product descriptors that match with official or commercial shipping and/or invoice 
documents   
c) Be prepared by the manufacturer on letterhead . 
d) Be signed and dated by the quality manager  of the manufacturer  or equivalent . 
(2) The manufacturer’s declaration will be valid for 12 months  from date of signing, or when there is a 
change in product formulation, whichever occurs soonest.  Import Health Standard: Biological Products    
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Certificate of irradiation  
(3) 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 s ervice provider on  letterhead .  
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  
(4) A declaration for naked 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 a declaration  confirming the requirements of this IHS  have been met.  
b) Be prepared by the supplier  on letterhead of the appropriate organisation.  
c) Be signed and dated by the  supplying organisation’s  Head of Department , their delegate,  or 
equivalent . 
1.8 Transitional arrangements for importers with a valid import 
permit issued under the Import Health Standard for Biological 
Products (including samples), BIOPRODIC.ALL 
(1) For importers with a valid import permit issued under the Import Health Standard for Biolo gical 
Products (including samples), BIOPRODIC.ALL , the requirements of this import health standard f or 
importing biological products  (BIOLOGIC.ALL)  may be met by complying with the requirement s of 
BIOPRODIC.ALL  in force immediately before the revocation of  the BIO PROD IC.ALL.  
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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 Zealand 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  (section 7.1 of guidance) . 
2.3 Biological products for use within a transitional faci lity 
(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 this IHS . 
 
Guidance  
• See Guidance Document  for more information on biological products for use within a transitional 
facility  (section 7.4 of guidance) . 
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Schedule 1 – Document History  
Date First Issued  Title Shortcode  
17 December 2021  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 .  
Agricultural compound  
An agricultural compound h as the same meaning as given in section 2 of the Agricultural Compounds and 
Veterinary Medicines Act 1997 . 
Appropriately approved transitional facility  
An MPI -approved transitional facility that has been approved for the type  of uncl eared biological products.  
Catgut suture  
A surgical suture manufactured from collagenous fibres of the submucosa of animals . 
Commercially manufactured and p ackaged  
A product manufactured in a commercial environment  by a commercial enterprise and is packaged and 
labelled in sealed containers or in t amper -proof packaging  and is intended for retail or wholesale. This does 
not include home -made products.  
Competent Authority  
The Veterinary or other Governmental Authority  of an OIE Member country 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 Terrestrial  Code 
and the OIE Aquatic Animal Health Code in the whole territory  of that OIE member . 
Director -General  
The chief executive of the Ministry for Primary Industries  or his/her delegate . 
General import permit  
A permit issued by the Director -General of MPI pu rsuant to section 24D(2) of the Act where the biosecurity 
risks associated with the product listed in the permit have been assessed by MPI and concluded to be 
managed effectively.  
Good Manufacturing Practice  
A Competent Authority -approved system aimed at e nsuring medicinal products are consistently produced and 
controlled according to quality standards appropriate to their intended use and as required by the product 
specification . 
Highly purified  
A product that is pure and free of any foreign, extraneous or  objectionable elements.  
In-vitro  
A process or reaction carried out outside a living organism (including, but not limited to, in a culture dish or 
test tube).  
In-vivo  
A process or reaction (such as a study or experiment)  carried out in side a living organism.  Import Health Standard: Biological Products    
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Medicine  
A medicine for human use, as defined in the Medicines Act 1981.  
Microorganism  
A microscopic organism including protozoa, fungi, bacteria, viruses, unicellular algae and prions.  
MPI 
Ministry for Primary Industries, New Zealand.  
Official Veterinarian  
A veterin arian authorised by the Competent Authority of the relevant OIE member  country  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 wi th the provisions of the OIE Code  Chapter for certification 
procedures.  
OIE 
The World Organisation for Animal Health.  
OIE Code  
The OIE Terrestrial Animal Health Code as found on the OIE website.  
Quality Management System (QMS)  
Documented policies and procedures carried out to meet the requirements of an MPI -approved transitional 
facility. Referred to previously as an operating manual.  
Restricted import permit  
A permit issued by the Director General of MPI pursuant to section 24D(2) of the Act where the pro duct is 
assessed by MPI and concluded to pose a risk to New Zealand. Such products are required to be held and/or 
used in an appropriate MPI approved transitional facility.  
Sample  
A small part intended as a representative of the whole.  
Sterilised  
A process  applied to completely remove viable microorganisms or render  the microorganisms non -viable.  
Test kit 
A product containing reagents and other items necessary to conduct a n in-vitro test to detect the presence of , 
or to measure a given quantity of, a specific facto r.  
Therapeutic use 
Applies only to humans and h as the same meaning as therapeutic  purpose  as defined in section 4 of the 
Medicines Act 1981 . 
Veterinary biological implant  
Biological tissue harvested from a donor animal for insertion or grafting into a recipient animal. The term 
includes autograft, allograft, and xenograft.  Import Health Standard: Biological Products    
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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.  
Veterinary medicine  
Veterinary medicine has the same meaning as given in section 2 of the Agricultural Compounds and Veterinary Med icines Act 1997.  
 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 is required on the shipping 
documents. The declaration must  confirm 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. The 
declaration must  compl y with clause 1.7.2 of this IHS and confirm  that: 
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  (section 7.2 of guidance) . 
− recommended format for model manufacturer declarations  (section 7.5 of guidance) . 
− recommended format for veterinary certificates  (section 5.4 of guidance) . 
− recommended declaration to use if clearance is sought under Schedule 4 ( section 7.1(2) of guidance) . 
− supporting documentation for the tested, filtered and irradiated Australian -origin and/or New Zealand -origin fetal bovine serum,  calf serum and bovine serum from 
Australia  (section 5.4 of guidance).  
− commercially manufactured and packaged risk goods (section 7.4.1 of guidance).   
 
 
NO IMPORT PERMIT REQUIRED  
Commodity  Requirements  
Amino acids  A signed and dated manufacturer’s declaration is required . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm that  the commodity:  
(1) Is commercially manufactured and packaged; and  
(2) Is for laboratory use.   
Antibiotics and antimicrobials  A signed and dated manufacturer’s declaration is required . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm that  the commodity:  
(1) Is commercially manufactured and packaged;  and 
(2) Is for laboratory use; and   
(3) Is not for use in production of pro ducts destined for use in and/or on  animals . 
Dried, non -viable invertebrates for scientific research or display at an 
institution  
  A signed and dated declaration is required . The declaration must  compl y with clause 1.7.2 of this IHS and 
confirm that  the commodity is:  
(1) Free of visible, viable pests; or  
(2) Treated pre -export by fumigation with methyl bromide; or  Import Health Standard: Biological Products    
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(3) Commercially prepared insects  in glass display cases.  
An alternative measure is treatment by fumigation with methyl bromide at the port of entry at the importer’s 
expense.  
Highly purified or sterilised laboratory reagents or highly purified 
sterile products produced from egg  A signed and dated manufacturer’s declaration  is required . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm  that the commodity:  
(1) Is commercially manufactured and packaged; and  
(2) Is highly purified and sterilised; and  
(3) Is not for use in the production of products destined for use in and/or on animals . 
Highly purified and/or sterilised products derived from blood for 
laboratory use  that do not contain risk goods and that are not bovine 
serum albumin (BSA) or fetal calf serum (FCS)  A signed and dated manufacturer’s declaration  is required . The declaration must  compl y with clause 1.7.2 
of this IHS and  confirm that  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 irradiation 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 (50 kGy); and  
(2) Sealed in a hermetically sealed container that is clearly linked to the certificate of irradiation.  
Laboratory culture media containing biological pr oducts of animal 
origin  (1) Must be commercially manufactured and packaged; and  
(2) Must be labelled for in -vitro use only; and  
(3) Either:  
a) The packaging identifies the media as sterile; or  
b) A signed and dated manufacturer’s declaration is required. The declaration must  compl y with 
clause 1.7.2 of this IHS and confirm the media:  
i) Has been sterilised to completely remove viable microorganisms or render any 
microorganisms non -viable; and  Import Health Standard: Biological Products    
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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 linked 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 . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm  that 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 fixed onto glass microscope slides; and  
(2) Must be under glass coverslips.  
Naked DNA, RNA, and/or nucleic acid  A signed and dated declaration is required . The declaration must  compl y with clause 1.7.2 of this IHS and 
confirm that  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 manufa cturer’s declaration is required . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm that  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.  
Preserved/fixed specimens of animal tissues  Preservation method one :  
Preserved with a minimum 
of: 
(1) 10% liquid formalin; 
or 
(2) 70% alcohol  Preservation method two :  
Fixed in 2%  to 4% 
glutaraldehyde for tissues:  
(1) Less than 2 mm thick for 
electron microscope 
imaging; or  Preservation method three :  
(1) Fixed in glyoxal if equal to, or less 
than, 2  mm thick.  Import Health Standard: Biological Products    
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(2) Larger samples by 
intravascular active 
perfusion  
A signed and dated declaration is required . The declaration must  compl y with clause 1.7.2  of this IHS  and 
confirm the  preservation method used.  
Preserved whole animal specimens (including invertebrates), 
specimens of parasites, and animal faec al specimens  A signed and dated declaration is required . The declaration must  compl y with clause 1.7.2 of this IHS and 
confirm that  the commodity:  
(1) Is preserved with a minimum of:  
a) 10% liquid formalin; or  
b) 70% alcohol  
(2) Or, for invertebrates, also embedded in amber, resin, or similar solid coating.  
Purified products derived from microorganisms  A signed and dated manufacturer’s declaration is required. The declaration must  compl y with clause 1.7.2 
of this IHS and confirm  that 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 . The declaration must  compl y with clause 1.7.2 
of this IHS and confirm that the commodity:  
(1) Is commercially manufactured and packaged; and  
(2) Is for laboratory use.  
Tested, filtered and irradiated Australian -origin and/or New Zealand -
origin fetal bovine serum , calf serum and bovine serum from 
Australia  (1) The product must be c ommercially manufactured, packaged, and sealed; and  
(2) A signed and dated manufacturer’s declaration is required . The declaration must  compl y with 
clause 1.7.2 of this IHS and must state:  
I, ......................................., being the manager of the factory where the tested, filtered and irradiated fetal bovine serum, cal f 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 equ ivalent to the current Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  20 of 25 
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 (st rikethrough 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 memb rane 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 bov ine rhinotracheitis, 
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 fetal bovine serum, it was obtained from blood collected from fetuses whose dams were born and raised in Australia or New Zealand.  
d) Either (strikethrough or delete non -applicable statement) : 
i) Product sourced from abattoirs was derived from animals that passed antemortem and 
postmortem inspection and were processed in premises under the supervision of the 
controlling authority and in accordance with the regulations of Australia or 
New Zealand; o r 
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 
(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 m anufacturer’s 
declaration.  
Test kits that do not contain viable microorga nisms  A signed and dated manufacturer’s declaration is required . The declaration  must compl y with clause 1.7.2 
of this IHS and confirm that the commodity:  
(1) Is commercially manufactured and packaged; and  
(2) Does not contain viable microorganisms; and  
(3) Is for lab oratory use.  Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  21 of 25 
 
GENERAL  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Requirements  
Agricultural compounds described in Column 1 of Schedule 2 of 
the Agricultural Compounds and Veterinary Medicines (Exemptions 
and Prohibited Substances ) Regulations 2011  (1) Must be commercially manufactured and packaged; and  
(2) If a biosecurity assessment concludes the risks are effectively managed  for agricultural compounds 
that do not meet the requirements for biosecurity clearance under another IHS, a general import 
permit is required.  
Antisera and antibodies derived from laboratory -raised guinea pigs, 
hamsters, mice, rabbits, and rats  (1) Must be commercially 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.  
Biological ingredients for inclusion in growing media for 
bioproduction of veterinary vaccines  (1) Must be commercially manufactured and packaged; and  
(2) If a biosecurity assessment concludes the risks are effectively managed, a general import permit is 
required.  
Biological ingredients importe d for formulation into agricultural 
compounds in New Zealand.  (1) Must be commercially manufactured and packaged; and  
(2) If a biosecurity assessment concludes the risks are effectively managed, a general import permit is 
required.  
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 specif ic 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.  Veterinary medicines that are authorised under sections 21 
(registration), 27 (provisionally registered), 8C (research approval), 
and 8C (special circumstances approval) of the ACVM Act.  
Excludes veterinary medicines that are b lood plasma pro ducts.  (1) Must be subject to a biosecurity assessment, and  
(2) If the biosecurity assessment concludes the risks are effectively managed, this will be communicated in an appropriate ACVM authorisation.  
(3) For veterinary medicines authorised under section 21 (registration) of the ACVM Act, must be in 
ACVM -approved packaging.  
 Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  22 of 25 
GENERAL  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Requirements  
Catgut sutur e (1) Must be 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 . 
a) Information r equired  to support the biosecurity assessment must confirm :  
i) That the relevant bovine spongiform e ncephalopathy (BSE) recommendations of the 
OIE’s Terrestrial Animal Health Code are met if the product is manufactured from bovine 
tissues;  
ii) That the relevant scrapi e recommendations of the OIE’s Terrestrial Animal Health Code 
are met if the product is manufactured from ovine tissues ; 
iii) The manufacturing process ; and  
iv) Any other relevant factors.  
Veterinary biological implants  (1) If a biosecurity assessment concludes the risks are effectively managed, a general import permit is 
required.  
 Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  23 of 25 
Schedule 5 – Biological products for use within a transitional facility  
Guidance  
• See Guidance Document  for more information about:  
− commercially manufactured and packaged risk goods  (section 7.4.1 of guidance) . 
− non-commercially manufactured and/or packaged laboratory un -sterilised/un -purified products  (section 7.4.2 of guidance) . 
− samples for analytical testing  (section 7.4.3 of guidance) . 
− the recommended format for  model manufacturer declarations  (section 7.5 of guidance) . 
− the recommended format for veterinary certificates  (section 5 .4 of guidance) . 
− supporting documentation for the Australian -origin and/or New Zealand- origin fetal bovine serum, calf serum or bovine serum for further processing  from Australia  
(section 5.4 of guidance) . 
• The facility standard relating to biological products  contains further information regarding  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/ Quality Management System (QMS)  or 
MPI-STD-ABRT  so that after processing, it is no longer considered 
by MPI to be a risk good . 
Australian -origin  and/or 
New Zealand- origin fetal  bovine 
serum, calf serum or bovine 
serum for further processing  from 
Australia  (1) Must be c ommercially manufactured, packaged, and sealed; 
and 
(2) A signed and dated manufacturer’s declaration  is required . 
The declaration must  compl y with clause 1.7.2 of this IH S and 
must state:  
I, ......................................., being the manager of the factory 
where fetal 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 that  
comply with an industry -accepted code of good (1) Filtered to 0.22 micron  or less;  and 
(2) Irradiated with a single or multiple irradiation dose totalling 
5 mrad (50  kGy)  Import Health Standard: Biological Products    
  17 December 2021  
Ministry for Primary Industries   Page  24 of 25 
RESTRICTED  IMPORT PERMIT REQUIRED (copy acceptable)  
Commodity  Importation requirements  Clearance requirements  
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) The products were derived from cattle born and reared 
in Australia  or New Zealand. In the case of fetal bovine 
serum, it was obtained from blood collected from fetuses 
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 antemortem and 
postmortem 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 
(3) A signed and dated veterinary certificate is required . The 
certificate must  compl y with clause 1.7.1 of this IHS and must 
state 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 
Schedule 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/ QMS  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    
  17 December 2021  
Ministry for Primary Industries   Page  25 of 25 
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 requ ired. 
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/ QMS  or MPI -STD-ABRT  so that after 
processing, it is no longer considered 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/ QMS  or MPI -STD-ABRT  so that after 
processing, it is no longer considered by MPI to be a risk good .