Guidance Document  
 
A guidance document issued by the Ministry for Primary Industries  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Biological Products  
BIOLOGIC.ALL  
[Document Date]  
 Guidance Document : Biological Products  
 Draft for Consultation  [Document Date]  
Ministry for Primary Industries  Page  1 of 13 
Title 
Guidance Document : Biological Products . 
About this document  
This guidance document contains information about acceptable ways of ensuring compliance with the 
requirements  in the Import Health Standard ( IHS): Biological Products . 
Any guidance on how to comply with the applicable requirements may not be the only way to achieve 
compliance. Stakeholders are encouraged to discuss departures from the approaches outlined in thi s 
guidance document with the Ministry for Primary Industries (MPI) to avoid expending resources on the 
development of alternative approaches which may later be considered unsuitable.  
The term “must” is not typically used in guidance. In this particular doc ument if the term “must” is used, it is 
used in the context of quoting or paraphrasing the requirements set out in the related IHS: Biological 
Products . 
Related Requirements  
Import Health Standard: Biological Products  
Document  history  
Refer to Appendix 1.  
Contact Details  
For further information and questions about this guidance document, please contact:  
 
Ministry for Primary Industries  
Agriculture & Investment Services  
Animal Imports  
PO Box 2526  
Wellington 6140  
 
Email: animal.imports@mpi.govt.nz  
Disclaimer  
This guidance does not constitute, and should not be regarded as, legal advice . While every effort has been 
made to ensure the information in this guidance is accurate, the Ministry for Primary Industries does not accept 
any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be 
present, however it may have occurred.  
Copyright  
Crown copyright ©. This copyright work is licensed under the Creative Commons Attribution 3.0 New Zealand 
licence. In essence, you are free to copy, distribute and adapt the work, as long as you attribu te the work to the Ministry for Primary 
Industries and abide by the other licence terms. To view a copy of this licence, visit http://creativecommons.org/licenses/by/3.0/nz/ . 
Please note that n o governmental emblem, logo or Coat of Arms may be used in any way which infringes any provision of the Flags, 
Emblems, and Names Protection Act 1981 or would infringe such provision if the relevant use occurred within New Zealand. 
Attribution to the Minis try for Primary Industries should be in written form and not by reproduction of any such emblem, logo or Coat of 
Arms.  
Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  2 of 13 
Contents  Page 
1 Purpose  3 
2 Background  3 
3 Definitions  3 
4 Importer Responsibilities  3 
4.1 Equivalence  3 
4.2 Incorporation of material by reference  4 
4.3 Harmonised system (HS) codes  4 
4.4 Exporting country systems and certification  4 
4.5 Eligibility  5 
4.6 Biological products derived from humans  6 
4.7 Packaging and transport  6 
4.8 Import permit  6 
4.9 Inspection and verification  6 
5 Exclusions  7 
6 Specified Requirements for Biological Products  7 
6.1 Biological products that can be cleared on entry to New Zealand  7 
6.2 Biosecurity requirements for ACVM registered products or exempt products  8 
6.3 Biosecur ity risk assessment  8 
6.4 Biological products for use within a transitional facility  9 
6.5 Model manufacturer’s declaration  11 
Appendix 1 – Document History  13 
 
  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  3 of 13 
1 Purpose  
(1) This guidance document has been issued to accompany the Import Health Standard : Biological 
Products . This guidance document should be read in conjunction with that IHS.  
(2) This document includes:  
a) Model manufacturer’s declarations . 
b) The links to the m odel veterinary certificate s for Australian -origin foetal bovine serum, calf serum 
and bovi ne serum . These country -specific veterinary certificate s represent what will be certified 
prior to exporting consignments of foetal bovine serum, calf serum and bovine serum  from the 
country specified.  
2 Background  
(1) The IHS: Biological Products , which this guidance document accompanies, contains generic import 
requirements. These are the rules to manage the biosecurity risk of importing  biological products  from 
all countries that can meet the requirements of the IHS and in doing so meet New Zealand’s 
appropriate le vel of protection.  
3 Definitions  
(1) Refer to Schedule 2 of the IHS: Biological Products . 
4 Importer Responsibilities  
(1) The costs to MPI in performing functions relating to the importation of  biological products will be 
recovered in accordance with the Biosecurit y Act 1993 (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.  
(2) Consignments that do not comply with the requirements of the IHS may be re -shipped or destroyed 
using an MPI -approved destruction method .  
4.1 Equivalence  
(1) MPI may accept an alternative method, system or process to that in this IHS to maintain at least the 
same level of protection assured by the measures in this IHS.  
(2) 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 . 
(3) An import  permit may be required where specific equivalence measures are approved by MPI. A n 
import permit serves as evidence of equivalence decisions which  will be written as specific notes in the 
special conditions section of the permit.  
(4) An import permit applicat ion form  can be found at the following link : Permit to Import Biological 
Products, Micro -organisms & Cell Cultures .  
(5) The importer should complete all information requested on the application form.  
(6) Completed applications are lodged with animal.imports@mpi.govt.nz . Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  4 of 13 
4.2 Incorporation of material by reference  
(1) Because some technical documents are too large or impractical to include in the IHS, they are 
incorporated by reference into the IHS. Incorporation by reference means that standards, guidelines or 
lists are incorporated into the IHS and they form part of t he requirements.  
(2) Where the IHS states that section 142O(1) of the Act does not apply, this means that importers need to 
refer to the most recent version of any standards, guidelines or lists that are incorporated by reference 
in the IHS.  
4.3 Harmonised system  (HS) codes  
(1) The harmonised system is an international product numbering classification developed by the World 
Customs Organisation (WCO). The New Zealand harmonised system is found here: 
http://aria.stats.govt.nz/aria/   
(2) Biological  products imported using the IHS will be under the following HS Codes:  
 
HS Code  Commodity Description  
05 Animal originated products; not elsewhere specified or included  
3808 Insecticides, rodenticides, fungi cides, herbicides, anti -sprouting products, plant growth 
regulators, disinfectants and the like, put up in forms or packings for retail sale or as 
preparations or articles    
3821  Prepared culture media for the development or maintenance of micro -organisms  (including 
viruses and the like) or of plant, human or animal cells  
3822  Reagents; diagnostic or laboratory reagents on a backing and prepared diagnostic or 
laboratory reagents whether or not on a backing, other than those of heading no. 3002 or 
3006; ce rtified reference material  
4.4 Exporting country systems and certification  
4.4.1 Agreed country specific veterinary certificates  
(1) The country -specific veterinary certificates  for bovine serum  agreed between an Australia ’s Competent 
Authority and MPI are included in the table below:  
 
Country  Link to certificate  S27 CTO 
direction #  Date agreed  Date applicable 
for use  
Australia  Tested, filtered and irradiated 
foetal bovine serum, calf 
serum and bovine serum     
Australia  Foetal bovine serum, calf 
serum and bovine serum for 
further processing     
(2) Country -specific veterinary certificates with equivalent measures will be recorded with a number 
relevant to a CTO direction issued under section 27(1) (d)(iii) of the Act, to enable border staff to clear 
the goods and record the number in the MPI database.  
(3) When a newly negotiated country -specific veterinary certificate replaces one which is currently in use, 
the application of new import conditions will ap ply according to the dates listed in the table  above .  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  5 of 13 
(4) When a  new country -specific veterinary certificate is agreed, there will be a four -month transition 
period to allow foetal bovine serum, calf serum and bovine serum  to be prepared in accordance with 
the new conditions. During transition, both the old and the new import conditions are acceptable. After 
transition, the previous veterinary certificate for that country can no longer be used.  
4.5 Eligibility  
(1) Imported biological products  (including foetal bovin e serum, calf serum and bovine serum from 
Australia)  fall into the four categories listed in the IHS. Further information about the four categories is 
included below.  
4.5.1 Laboratory research, diagnostic and analytical purposes  
(1) This includes equipment calibrati on and validation.  
(2) Generally , such use would be conducted in a laboratory -type environment, including (but not limited to)  
Crown Research Institutes, universities, private research institutions, diagnostic testing laboratories  
and veterinary laboratories . 
4.5.2 Animal product samples for evaluation and/or proficiency testing  
(1) While the size and volume of a sample can be arbitrary, it is recognised that samples  are imported for 
purposes different from that of the whole. Importers should endeavour to keep the size, volume and 
quantity of samples to a minimum in order to ensure that the purposes of import are within the scope of 
the IHS and the scope of the transit ional facility approval . 
(2) Animal product samples for evaluation should  meet all conditions on the import permit . The transitional 
facility listed on the import permit  is to be approved at the time of import under  one of the following MPI 
transitional facility standards ( appropriate to commodity ) or whichever facility standard replaces them : 
a) For further processing , Transitional Facilities for  Animal Products, MPI -STD-ANIPRODS ; or 
b) For testing and evaluation , 154.02.17 – Transitional Facilities for Biological Products . 
(3) As stated in the IHS, animal product samples may be eligible for clearance if treated in a MPI approved 
facility as per the rele vant IHS. The IHS search page can be found here: http://www.mpi.govt.nz/law -
and-policy/requirements/import -health -standards/  
4.5.3 Environmental use  
(1) Environmental uses include a range of commercially manufactured and packaged products, for 
example; effluent biodegraders, biofertilisers.  
(2) Also refer to the exclusion section of this guidance document  (section 5)  relating to the importation of 
viable micr oorganisms.  
(3) A biosecurity clearance is required before a biological product can be used in the environment.  
4.5.4 Use in, or on humans, animals or plants  
(1) Use of a biological product in or on humans, animals or plants  includes for medical, veterinary or 
horticult ural use.  
(2) Biological products intended to be used therapeutically on or in humans, include, but are not limited to; 
antibiotics, medicines, inactivated vaccines, bioprosthetic devices and surgical implants/equipment.  
(3) Additional requirements under the Agric ultural Compounds and Veterinary Medicines Act 1997 (ACVM 
Act) may apply  for use  of biological products  on animals and plants.  
a) For information about agricultural compounds and veterinary medicines , refer to  section 6. 2 of 
this document and https://www.mpi.govt.nz/processing/agricultural -compounds -and-vet-
medicines/ .  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  6 of 13 
4.6 Biological products derived from humans  
(1) Any products containing infectious agents that  can be transmitted between (or are shared by) animals 
and humans are not eligible for clearance. See exclusions section  (Section 5 ). 
(2) Non-viable b iological products derived from humans are not subject to the IHS requirements and are 
eligible for biosecurit y clearance.  This is because:  
a) Human beings are not considered to be organisms for the purposes of the Act and, therefore, are 
not risk goods in themselves.  
b) While there are products derived from, and associated with, human beings that are considered 
as pot ential hazards under the Act, these have been assessed by MPI to be of negligible risk and 
can be considered not to be risk goods.  
(3) Please note that there may be legislation managed by the New Zealand Ministry of Health and the 
Ministry of Business, Innovation & Employment that applies to these goods.  
4.7 Packaging and transport  
(1) Uncleared biological products should be transported in a secure and double contained manner to 
prevent spillage or contamination of the transporting vehicle, other cargo and/or the environment . 
(2) Importers should ensure that packaging materials are not biosecurity risk goods in themselves.  
Materials should also be clean, dry and free from any contaminating material.   
4.8 Import  permit  
(1) The i mport permit application form can be found on the MPI website at: Permit to Import Biological 
Products, Micro -organisms & Cell Cultures .  
(2) The importer should complete all information requested on the application form.  
(3) Completed applications are lodged with animal.imports@mpi.govt.nz . 
4.9 Inspection and verification  
(1) On arrival, all documentation accompanying the consignment may be verified by an inspector. The 
inspector may also inspect the consignment, or a sample of the consignment , on arrival.  
(2) Inspectors are able to inspect and verify due to their authorised powers  under the Act.  These 
requirements are independent of the IHS requirements.  
  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  7 of 13 
5 Exclusions  
(1) The categories of biological products not eligible for importation under this IHS are:  
a) Biological products which are eligible for movement and/or clearance under anoth er IHS must be 
moved and/or cleared under that IHS.  
i) For e xample: There are a number of IHSs  relating to animal products, such as  milk and 
milk products , egg products,  and bee products .  
ii) For a list of other IHSs refer to the MPI website: 
http://www.mpi.govt.nz/importing/overview/import -health -standards/  
iii) Products which do not comply with the clearance requirements of another IHS must be  
accompanied by an import permit which requires the product to be held and/or used in an 
appropriately approved transitional facility (as listed on the import permit).  
b) Biological products that are micro organisms ; or biological products that contain viable 
microorganisms which are imported with the intention of isolating or culturing microorganisms 
from the samples, or use d for microorganism enrichment. Examples include, but are not limited 
to, viruses, bacteria, p rions and protozoa . 
i) This i ncludes for purposes where the microorganisms may, or may  not be, rendered non -
viable as part of the processing.  
ii) Such products are subject to the Import Health Standard: Microorganisms from A ll 
Countries , MICROIC.ALL  (or any IHS which replaces that standard ). 
c) Biological p roducts  that are, or contain, viable cell cultures/non -microbial cells  where, for 
example, products are imported with the intention of cell isolation and/or culture.  
i) This i ncludes  for purposes where the cultures/non -microbial cells may, or may not be, 
rendered non -viable as part of the processing.  
ii) Such products are subject to the Import Health Standard: Cell Cultures from All Countries , 
CELLCULIC.ALL  (or any IHS which replaces that standard ).  
6 Specified Requirements for Biological Products  
(1) Products , including those for therapeutic use on or in humans,  which contain honey must also comply 
with the requirements of the  Import Health Standard for Specified Processed Bee Products, 
BEEPROIC.ALL  (or any IHS which replaces that standard) .  
6.1 Biological products that can be cleared on entry to New Zealand  
(1) The biosecurity risks associated with the biological products described in Schedule 4  have been 
assessed by MPI and concluded to be managed effectively by the requirements of this IHS.  
(2) If a biological p roduct falls within  Schedule 4  of the IHS and  no import permit is required  under that 
Schedule , it is recommended that the accompanying documentation includes the declaration “Goods 
are included in section/subsection [insert relevant section/subsection here] category under Schedule 4  
of the IHS: Biological Products .” 
(3) If the commodity being imported is eligible for import under  another IHS, it must be imported under that 
IHS. 
(4) Importers of test kit s that  test for a notifiable organism or a reportable organ ism should be aware  there 
is a legal requirement to report a positive result immediately to MPI on 0800 80 99 66 .  
a) A positive test result for a notifiable organisms may be a false positive and is considered only 
‘suspicious’ until confirmed at the MPI Inve stigation and Diagnostic Centre (IDC) Animal Health 
Laboratory (AHL).  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  8 of 13 
b) When supplying test kits for exotic diseases to a third party, this party must be informed of the 
conditions listed above.  
(5) The use of a kit to create a genetically modified microorganis m (GMO) requires HSNO Act approval. 
Under the HSNO Act, anyone wanting to import or create a GMO must have approval from the EPA 
and strict criteria must be met regarding the organisms’  management and containment.  
6.2 Biosecurity requirements for ACVM  register ed, approved or 
exempt  products  
(1) Products registered or approved under the ACVM Act do not require an import permit under the 
Biosecurity Act 1993 (with the exception of biological products that require testing for each 
consignment). Products which contain ingredients of biological origin must have a biosecurity 
assessment, managed by the Animal and Plant Product Imports team s, before the product is 
registered or approved, and whenever a change in manufacturing process , source of ingredients  or 
formulation o ccurs.  
(2) Information regarding biosecurity  assessments for ACVM imports can be found on the MPI website 
here: http://www.mpi.govt.nz/importing/biological -products -and-organisms/biological -products/steps -to-
importing/biosecurity -assessments -for-acvm -imports/ .  
(3) Products  to be used in or on animals that contain products of biological origin but which are exempt 
from registration under the ACVM Act must  either meet the scope or intended purpose and 
requirements of an IHS  or undergo a biosecurity  assessment to determine if an  import permit  might be 
issued . Import application forms can be found under spec ific commodity type here: 
https://www.mpi.govt.nz/importing/     
6.3 Biosecurity risk assessment  
(1) The range of risk goods that are included within the definition of biological products is wide and 
diverse, as are the activities that may be undertaken with them. This means it is not possible to 
prescribe in this IHS how the biosecurity risks that may be associated with all such biological products 
and associated activities should be managed.  
(2) Where an importer a pplies to import a biological product not described in Schedules 3, 4 or 5  of the 
IHS, and there is no prior MPI risk assessment for that biological product, a specific risk assessment 
must be undertaken by MPI.  
a) The application and the specific risk asses sment  will need to be consulted on with “any other 
persons the officer considers to be representative of the classes of persons having an interest in 
it” as required by s ection  23(3)(b) of the Biosecurity Act 1993. This consultation can be targeted  
and any  commercially sensitive information will not be made available unless express permission 
has been given by the manufacturer of the biological product.   
b) The importer will be notified if consultation is required and of estimated timeframes.  
(3) An essential part  of allowing the importation of  biological products is to ensure that any biosecurity 
risks that such products  may present are identified, can be effectively managed and do not 
compromise the ability to maintain compliance with the Act, New Zealand’s inter national obligations, 
this IHS or any associated facility standard . This is to ensure animal, human and environmental 
elements are not exposed to risk organisms which may be contained within animal bodies, organs, 
tissues, cells, samples, blood, body fluid s or waste material.  
(4) A biosecurity risk assessment undertaken by MPI will include, but is not limited to, consideration of the 
following (where appropriate to the biological product ): 
a) The animal species the biological product derives from . Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  9 of 13 
b) The country the biological product derives from and the presence or absence of risk organisms in 
that country that may present a biosecurity risk to New Zealand . 
c) The type of biological product . 
d) The type of processing that may have been applied to the biological product th at may mitigate 
the presence of microorganisms . 
e) Intentional or unintentional exposure to animals, humans, and the environment . 
f) Why and how the biological product is proposed to be used (including, but not limited to, further 
processing, analysis, media pre paration, assays, use in or on animals) and the potential 
exposure route(s) . 
g) Frequency of exposure to people and/or animals . 
h) Details of any human or animal diseases or environmental damage (biosecurity and biosafety 
factors) that may be associated with exp osure to, or release of, biological agents or hazards . 
i) Measures to mitigate each risk to the lowest level that is reasonably practicable (necessary 
control measure(s)) .  
6.4 Biological products for use within a transitional facility  
(1) Biological products that ha ve an unknown health status, or are known to be infected, or have a risk of 
harbouring unwanted or exotic organisms , are a risk to New Zealand’s biosecurity . Such biological 
products  may not be eligible for movement or clearance,  subject to a risk assessment of that product 
and depending on whether or not a transitional facility has been approved for that type of product . 
(2) As a general guide, biological products to be used  within an appropriately approved transitional facility 
include, but are not limited to :  
a) Animal tissues or product samples . 
b) Blood and serum products . 
c) Semen . 
d) Faeces and urine . 
(3) The exception to this is if the products are covered by another IHS. If this is the case, the biological 
products would be subject to the conditions within that specific IHS.  
(4) If the risk goods are arriving via the passenger route, the goods will need to be couriered from the port 
of first arrival  to the transitional facility named on the import permit if:  
a) The passenger is not going directly to the transitional facility named on the import permit; or 
b) The passenger is not named on the import permit, or does not have a letter from the operator of 
the transitional facility or the import permit holder authorising  the use of the import permit.  
(5) The transitional facility is to be appropriately approved under a transitional facility standard relevant to 
the commodity. The transitional facilities will most likely  be approved under one of the following facility 
standard s (or any facility standard that replaces these  standards ): 
a) Transitional Facilities for Biological Products, 154.02.17  
b) Transitional Facilities for General Uncleared Risk Goods, TFGEN  (approved to allow holding of 
(not opening/using)  biological products only)   
c) Transitional Facilities for Animal Products, MPI -STD-ANIPRODS  
6.4.1 Commercially manufactured and packaged risk goods  
(1) Commercially manu factured and packaged products comprised of animal products that are risk goods  
that do not meet the requirements of Schedules 3  and/or 4 of this IHS  must be accompanied by a 
relevant import permit which requires the product to be moved to an  appropriately  approved 
transitional facility (as listed on the import permit).  
(2) This includes, but is not limited to, products comprised of blood, serum and/or serum proteins. It 
excludes test kits for laboratory use  that do not contain viable microorganisms . Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  10 of 13 
6.4.2 Non-commer cially manufactured and/or packaged , un-sterilised/ un-purified laboratory 
products  
(1) Non-commercially manufactured and/or packaged laboratory un-sterilised/ un-purified products may not 
have  been treated to sufficiently inactivate or remove potential  contaminating microorganisms , and are 
required to be moved to an appropriately approved transitional facility (as listed on the import permit).  
(2) Examples may include , but are not limited to :  
a) Culture media . 
b) Egg products . 
6.4.3 Samples from clinically healthy ani mals for analytical testing  
(1) Samples  from clinically healthy animals  for analytical testing , that do not meet anothe r IHS, fall under 
Schedule 5  of the IHS and must be accompanied by a  restricted  import permit which requires the 
product to be moved to  an appropriately approved transitional facility (as listed on the import permit).  
(2) The species of animal, the country of origin, the sample type and d etails of the tests to be undertaken 
need to be provided.  
(3) Examples of samples  from clinically healthy animals  for analytical testing that must  be held and used in 
a transitional facility include, but are not limited to : 
a) Blood and milk samples (note: s amples intended for  microorganism enrichment, isolation and/or 
culture  must be imp orted under the Import Health Standard for Microorganisms  or whichever IHS 
replaces it ). 
b) Samples for trace element testing , nutritional analysis, and chemical analysis . 
(4) Samples collected from clinically unhealthy animals or animals suspected of being at high risk of an 
exotic disease are not considered an acceptable risk for most New Zealand transitional facilities.  
  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  11 of 13 
6.5 Model manufacturer’s declaration  
(1) Commerc ially manufactured and packaged:  
a) Amino acids.  
b) Antibiotics / antimicrobials.  
c) Test kits that do not c ontain viable microorganisms.  
d) Products derived from microorganisms.   
e) Restriction enzymes . 
 
Company Letterhead  
1. Importer name:  
Address:  
 
 
2. Country of destination: New Zealand  3. Country of origin:  
 
4. Description of commodity:  
 
5. Invoice number:  6. Nature of packaging:  
7. Number of packages:   
8. Number of container(s) :  
I, _______________________________________________ the Quality Manager (or equivalent) of the manufacturing 
premises declare that:  
(1) The commodities in this consignment are (strikethrough or delete non-applicable categories) : 
(a) Amino acids;  
(b) Antibiotics / antimicrobials;  
(c) Test kits that do not contain viable microorganisms;  
(d) Products derived from microorganisms;  
(e) Restriction enzymes  
(2) All the commodities in this consignment are: 
(a) Commercially manufactured and packaged;  
(b) In new, clean, and secure  packaging ; and  
(c) For in-vitro laboratory use  
Name of authorised person:  
Position:  
Signature:                                                                                           Date:  Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  12 of 13 
(2) Commercially manufactured and packaged : 
a) Un-sterilised laboratory culture media that contains no ingredients of animal origin . 
b) Sterilised laboratory culture media.  
c) Highly purified/sterilised/chemically synthesised laboratory reagents or products derived from  
egg. 
 
Company Letterhead  
1. Importer name:  
Address:  
 
 
2. Country of destination: New Zealand  3. Country of origin:  
 
4. Description of commodity:  
 
5. Invoice number:  6. Nature of packaging:  
7. Number of packages:   
8. Number of container(s):  
I, _______________________________________________ the Quality Manager (or equivalent) of the manufacturing 
premises declare that : 
(1) The commodities in this consignment  are (strikethrough or delete non -applicable categories) : 
(a) un-sterilised laboratory culture media that contains no ingredients of animal origin; and/or  
(b) sterilised laboratory culture media; and/or  
(c) highly purified / sterilised / chemically synthesised laboratory reagents or products  derived from egg.  
(2) The commodities in this consignment have been  commercially manufactured and packaged; the packaging is new, 
clean , and secure ; and the commodities (strikethrough or delete non -applicable categories) : 
(a) have been sterilised to completely remove viable microorg anisms or render any microorganisms non -viable.; 
or 
(b) for products that contain, or are derived from , eggs  and egg products,  have  instead  been chemically 
synthesised ; or 
(c) do not contain any ingredients of animal origin, including blood, whole serum, animal proteins or animal 
tissues.  
(3) The commodities in this consignment are not for use in the production of products destined for use in or on animals 
as veterinary medicines.  
Name of authorised person:  
Position:  
Signature:                                                                                           Date:  
 Guidance Document : Biological Products  
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Ministry for Primary Industries  Page  13 of 13 
Appendix 1 – Document History  
Date First Issued  Title Shortcode  
03 June 2011  Guidance Document:  Biological Products 
(including samples)  BIOPRODIC.ALL  
Date of Issued Amendments  Title Shortcode  
14 March 2014  Guidance Document: Biological Products 
(including samples)  BIOPRODIC.ALL  
TBA Guidance Document: Biological Products  BIOLOGIC.ALL