Animal Ingredient Form¹ for New Drug Submissions² - July 28, 2006

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VETERINARY DRUGS DIRECTORATE (VDD)
Animal Ingredient Form for New Drug Submissions
(AIF-NDS)

SECTION 1 - PRODUCT IDENTIFICATION

Manufacturer/Sponsor:

Mailing Address:

Product Name:

Country of Manufacture:

For definitions, please refer to Health Canada/Santé Canada Form 3011: Guidance for Completing the Drug Submission Application Form.

SECTION 2 - SIGNING AUTHORITY³

I, the undersigned, certify that the information and material included in this AIF-NDS is accurate and complete.

I understand that this information may be used to conduct a risk-based assessment before any decision is taken with regard to the accompanying new drug product submission application. I agree that the company will inform the VDD accordingly if it changes either the source, or the type, of animal-sourced ingredient(s) used in the aforementioned product prior to, or after, receiving final approval (NOC).

Name and Title of Authorized Signing Official in Canada :

Signature:

Date (YYYY/MM/DD):

Mailing Address:

Email Address:

Telephone No.:

Fax No.:

Name of the Company to which the Authorized Signing Official Belongs

Date of Completion of the Form (YYYY/MM/DD):

SECTION 3 - MEDICINAL AND NON-MEDICINAL INGREDIENTS⁴

3.1 Medicinal (Active) Ingredient(s)⁵ (e.g., pituitary, hypothal amic releasing hormones)

(* If checked yes, complete Section 4 of this form)

Ingredient Name

Strength

Units

Per

Calculated as % in the Formulation

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

* Animal Source

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

Attach separate sheets (same format) if necessary. Number of pages attached: ___

3.2 Non-Medicinal Ingredient(s)⁶

3.2.1 Excipients⁷ (e.g., gelatin or capsular materials, tallow, collagen, multiple flavorings, colors)

(* If checked yes, complete Section 4 of this form)

Ingredient Name

Strength

Units

Per

*Animal Source

No Yes

No Yes

No Yes

No Yes

No Yes

Attach separate sheets (same format) if necessary. Number of pages attached: ___

3.2.2 Auxiliary Reagents⁸ (medium components used in culture/fermentation for example cell lines⁹, biological reagents such as bovine serum albumin, fetal calf serum, and/or enzymes)

(* If checked yes, complete Section 4 of this form)

Ingredient Name

Strength

Units

Per

*Animal Source

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

Attach separate sheets (same format) if necessary. Number of pages attached: ___

3.2.3 Raw, starting materials and/or reagents used in the synthesis or biosynthesis of drug substance¹⁰

(* If checked yes, complete Section 4 of this form.)

Ingredient Name

Used in which step of drug product synthesis or biosynthesis

* Animal Source

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

Attach separate sheets (same format) if necessary. Number of pages attached: ___

3.2.4 Processed materials used in the formulation of the drug product¹¹

(* If checked yes, complete Section 4 of this form.)

Ingredient Name

Used in which step of drug product formulation

* Animal Source

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

Attach separate sheets (same format) if necessary. Number of pages attached:

3.2.5 If you have used alternate ingredients from non-mammalian animals or plant sources, and have checked "no" for all the questions in Section 3, please do not complete Sections 4, 5 and 6.

SECTION 4 - ANIMAL-SOURCED INGREDIENTS

1. Ingredient Name 

2. Name of Manufacturer/Supplier: 

3. Animal Species: 

Bovine (cattle)
Deer
Elk (wapiti)
Water Buffalo
Bison
Ovine (sheep)
Poultry (chicken, turkey, hen, duck)

Caprine (goat)
Porcine (pig)
Equine (horse)
Feline (cat)
Moose
Caribou
Mink
Others:

4. Used As: 

medicinal ingredient
non-medicinal ingredient:

• excipients/capsular
• auxiliary reagents
• in processing of product as reagent/culture medium component (e.g. bovine serum albumin, enzymes)
• raw or starting materials or reagents or processed raw materials used in manufacturing

Others, please give details

5. Tissues, Fluids and/or Macromolecules Used: ^{12, 13, 14} 

brain / brain stem

placenta

adipose tissue/omentum

cerebellum

placenta fluids

bile

spinal cord

enzymes, (please specify)¹⁵ 

muscle, skeletal, (please specify)

skull

blood/blood products

cord blood

trigeminal ganglia

lymph nodes

bones (other than vertebral column and skull)

tonsils

pancreas

embryonic tissue/fetal tissue

dorsal root ganglia

kidney

ovarie

distal ileum

liver

tendons/ligaments

dura mater

appendix

thyroid/parathyroid

pituitary gland

gall bladder

mammary glands/ udder

cerebrospinal fluid

spleen

urine

fetal bovine serum

lung

semen

vertebral column

stomach

antler velvet

bone marrow

adrenal gland or tissue

milk/milk products

hypothalamus

large intestine

saliva/salivary gland

thymus

small intestine other than distil ileum

testes

retina/optic nerve

abdomen

skin/hides

other

eyes/cornea

colostrums

other

amino acid¹⁶ 

trachea

other

small peptide

heart/pericardium

other

other

nasal fluid

Attach separate sheets (same format) if necessary. Number of pages attached:

SECTION 5 - DRUG PRODUCTS FOR FOOD-PRODUCING ANIMALS¹⁷

If you checked Bovine, Water Buffalo, Bison, Deer, Elk, Sheep, Goat, Feline, Moose, Mink or Caribou in Section 4, please answer Question 1 below.

1. Is this drug product (listed in Section 1) that contains animal-sourced ingredients (indicated in Sections 3 and 4), intended for a food-producing animal?

Yes, please specify the animal(s):

No

If you answered "yes" to Question 1 in Section 5 above, please proceed with Section 6.

SECTION 6 - RISK ASSESSMENT

1. What is (or will be) the age of the animal(s) used to source the ingredients listed in Sections 3 and 4?

Under:    months OR ranging from:    months to    months.

2. BSE status of the country/countries from which the animal originated (or will originate)?^{18 , 19}

Category I, please specify which country

Category II, please specify which country

Category III, please specify which country

3. What is the TSE risk classification of each animal-sourced material?^{20 , 21}

high risk

medium risk

low risk

no detectable risk

4. What are the measures taken to remove, reduce or inactivate TSE prions?

Please list specific references to the method(s) used:

Attach separate sheets (same format) if necessary. Number of pages attached:

5. What are the measures taken to avoid cross-contamination among high, medium and low risk tissues, fluids and/or macromolecules²² :

during rendering

during processing

Attach separate sheets (same format) if necessary. Number of pages attached: ___

6. Please specify measures taken to avoid cross-contamination:

during manufacturing process (e.g. synthesis, purification, storage)²³;

please specify

during handling of batches used for clinical, safety, stability, comparative bioavailability studies;

please specify

during collecting, handling, storing, or shipping of tissues, fluids, and /or macromolecules;

please specify

Attach separate sheets (same format) if necessary. Number of pages attached:

7. Please specify and provide a TSE-Certificate of Suitability and/or a science-based risk assessment and/or other relevant documentation where:

the level of risk of TSE is not determined

the animal-sourced material is derived from an SRM

there is a disagreement between the sponsor and the VDD

Please specify the documentation(s) provided:

TSE-Certificate of Suitability²⁴

science-based risk assessment

other relevant documentation

APPENDIX 1
Instructions for Completion of the AIF-NDS

SECTION 1 - PRODUCT

Manufacturer/Sponsor

• Please indicate the full name of the manufacturer/sponsor in whose name the drug submission is filed.

Mailing Address

• Please provide the full mailing address of the manufacturer/sponsor.

Product Name

• Please provide the name that is assigned by the manufacturer/sponsor to distinguish the drug (or product) and under which the drug is to be sold and/or advertised.
• The brand name is the name used to identify the product in all correspondences.

Country of Manufacture

• Please provide the name of the country where the final dosage form of the drug product is manufactured/fabricated.

SECTION 2 - SIGNING AUTHORITY

• Please print the name of the person authorized by the manufacturer/sponsor identified in Section 1.
• The person signing this form is certifying that the information provided in the form is consistent with the wishes of the manufacturer/sponsor and that this signing authority is located in Canada.
• Please provide other relevant information as requested in this Section.
• Please do not abbreviate the company name.

(Note: the manufacturer/sponsor is not necessarily the company that fabricates the drug product.)

SECTION 3 - MEDICINAL AND NON-MEDICINAL INGREDIENTS

Medicinal Ingredients

• List the medicinal (active) ingredients present in the final dosage form of the drug product by its/their proper or common name(s).

(This information is comparable to Section 55 of Health Canada Form HC/SC 3011 Form and is required for all new drug submissions.)

Strength, Units

• The strength of the active ingredient(s) should be expressed as follows:

Discrete forms (e.g. tablet) - g or mg/pharmaceutical form
Powder for oral use - g or mg/ml, g or mg/dosage unit (e.g. /5 ml)
Liquid for parenteral use - mg/ml or %
Liquid for oral use - g or mg/ml, g or mg/dosage unit (e.g. /5 ml)
Cream, ointment, lotion, etc. - mg or ml/g, g or mg/ml or %

Non-Medicinal Ingredients, Including Excipients, Auxiliary Reagents, Medium Components used in Culture Fermentation, Raw, Starting Materials, and/or Reagents used in Synthesis or Biosynthesis, and Processed Materials

• Please list the non-medicinal ingredient(s) in a similar manner to the medicinal ingredient(s).
• There is no requirement to indicate whether the non-medicinal ingredient is calculated as a percentage in the formulation.

(This information is comparable to Section 56 of Health Canada Form HC/SC 3011 Form and is required for all new drug submissions.)

SECTION 4 - ANIMAL-SOURCED INGREDIENTS

Ingredient Name

• List ALL the animal-sourced medicinal and non-medicinal ingredients present in the drug product by their proper or common name.
• Please include all animal-sourced materials used during processing and manufacturing.
• Please complete a separate form for each individual ingredient

Name of Manufacturer/Supplier

• Please indicate the full name of the manufacturer/supplier of the animal-sourced ingredient.
• Please do not abbreviate the company name.

(Note: the manufacturer/sponsor is not necessarily the company that fabricates the drug product.)

Animal Species

• If ingredient is from a TSE-susceptible animal, please indicate the animal species.

Use

• Indicate whether the animal-sourced material is used as a:
• Medicinal Ingredient - an ingredient that contributes to the therapeutic effect of the product.
• Non-Medicinal Ingredient - an ingredient that does not contribute to the therapeutic effect of the product. Non-medicinal ingredients include:
• Excipients/Capsular Materials - any component of a finished dosage form that does not have medicinal properties and does not impart pharmacological activity.
• Auxiliary Reagents - raw material which is intended to be used as a processing aid in the fabrication of the final veterinary therapeutic product. It may be absent from the final product or may remain as an impurity in the final product at the end of the manufacturing process.
• Raw or starting materials or reagents or processed materials used in manufacturing
• Please list any components used in the fabrication of ingredients or the drug product, whether they are medicinal or non-medicinal.

Tissues, Fluids and/or Macromolecules Used

• Please specify tissues, fluids and/or macromolecules used to source the ingredients.
• Macromolecules include all enzymes, peptides and amino acids.

SECTION 5 - DRUG PRODUCTS FOR FOOD-PRODUCING ANIMALS

Food-Producing Animals

• The animals listed in Section 5 are susceptible to TSE. For this reason it is vital to know if the drug product fabricated from these animal-sourced materials is intended for a food-producing animal.

SECTION 6 - RISK ASSESSMENT

Animal Age

• Please indicate the age of the animal listed in Section 5.
• SRMs are usually defined not solely by tissue, fluid, and/or macromolecule source, but also by animal age. In general, for the majority of tissues, organs and fluids, except for distal ileum, no TSE infectivity is detectable in cattle under 30 months of age. For more information, please see the VDD's Draft Guidance for Industry: Minimizing the Potential Risks of Transmission of the Transmissible Spongiform Encephalopathy Agent via Veterinary Therapeutic Products Containing Animal-Sourced Ingredients, available at:
  http://www.hc-sc.gc.ca/dhp-mps/vet/
  applic-demande/guide-ld/index-eng.php.
• This information is important as TSE infectivity accumulates in bovine animals over an incubation period of several years and it is prudent to source the ingredient from young animals. For more information, please refer to the EMEA Notice for Guidance 5.2.8 available at: http://www.emea.eu.int/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf.

BSE Status of the Country

• Please indicate the appropriate BSE risk category of the country/countries which the animal originated from (or will originate) as Category I, II or III. For more information, please consult the CFIA BSE import policy for bovine animals and their products, December 2005, Section A.4., page 24 available at:
  http://www.inspection.gc.ca/english/anima/
  heasan/policy/ie-2005-9e.shtml.

Classification of Animal-sourced Material

• In Canada, SRMs include the brain, skull, trigeminal ganglia, cornea, tonsils, spinal cord, dorsal root ganglia of cattle 30 months or older and the distal ileum of cattle of all ages. For more information please refer to the Regulations Amending the Health of Animals Regulations, available at: http://www.inspection.gc.ca/english/reg/consultation/20069_e.shtml and the Regulations Amending the Food and Drugs Act and Regulations (1389-Specified Risk Material), available at:
  http://canadagazette.gc.ca/partII/2003/
  20030813/html/sor265-e.html. These amendments do not apply to food that originates from a country that is designated by the CFIA as being free from BSE.
• For classification of animal-sourced material according to its level of infectivity, please refer to the EMEA Note for Guidance 5.2.8., available at: http://www.emea.eu.int/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf.

Measures Taken to Inactivate TSE Prions

• In order to appropriately assess the risk of prions present in the final product formulation, it is important that all measures used to remove, reduce and/or inactivate prions are listed. Please provide appropriate references to the methods used.

Potential Risk of Cross-Contamination

• Please indicate the measures taken to avoid any cross-contamination among various tissues, fluids and/or macromolecules during rendering or processing of the raw materials and raw ingredients.

Appropriate Documentation

• Please provide the appropriate documentation in support of your application.

APPENDIX 3 - AUTHORIZATION FOR A THIRD PARTY TO SIGN

Please complete Appendix 3 only if the party signing the AIF-NDS is a third party acting on behalf of the manufacturer/sponsor identified in Section 1. (Note: A separate authorization is required for each AIF-NDS.)

APPENDIX 2
Questions and Answers regarding AIF-NDS

What is the issue?

Recent public health concerns such as TSE have highlighted the need to ensure that drug products being sold in Canada do not contain animal-sourced materials which could pose a potential risk of TSE to humans and animals. The VDD at Health Canada has developed the AIF-NDS to guide the industry, in cooperation with the VDD, in the implementation of a database of veterinary therapeutic products fabricated from animal-sourced ingredients indicated for food-producing animals.

What is Health Canada's role?

Health Canada 's role is to protect the health of humans and animals by monitoring Canada 's food supply. To ensure that veterinary therapeutic products marketed in Canada do not contain SRMs, Health Canada requires access to the most up-to-date information regarding animal-derived materials used in these products. With the cooperation of manufacturers/sponsors, the VDD intends to develop and maintain information on animal tissues, fluids and macromolecules for all Canadian marketed veterinary therapeutic products indicated for food-producing animals in order to ensure product safety. This information will be proactively used to mitigate future TSE risk in veterinary drug products.

What is a Specified Risk Material (SRM)?

In Canada , SRMs are defined as the brain, skull, trigeminal ganglia, cornea, tonsils, spinal cord, dorsal root ganglia of cattle aged 30 months or older, and the distal ileum of cattle of all ages. For more information, please refer to the Regulations Amending the Health of Animals Regulations, available at: http://www.inspection.gc.ca/english/reg/consultation/20069_e.shtml and the Regulations Amending the Food and Drugs Act and Regulations (1389 - Specified Risk Material), available at: http://canadagazette.gc.ca/partII/2003/20030813/html/sor265-e.html . These amendments do not apply to food that originated from a country that is designated by the CFIA as being free from BSE. Please also refer to the CFIA Web site for the current CFIA Import Policy, December 2005, available at: http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2005-9e.shtml .

What is the role of the drug manufacturer/sponsor?

The role of the sponsor includes the completion of the AIF-NDS as completely as possible in order to aid the VDD in populating the database. The role of the drug manufacturer is to ensure that all information regarding animal-sourced materials is obtained and remains up-to-date; all changes (of non animal-sourced to animal-sourced materials) shall be reported to the VDD within 30 days of the change (please see question regarding changes in ingredient sources).

This information was already submitted as part of a New Drug Submission (NDS) package. Does it need to be submitted again?

All manufacturers/sponsors of new veterinary products are now requested to submit the AIF-NDS along with the NDS package. This process will ensure that the VDD has access to updated information for all products, and it will facilitate the formation of a TSE database for veterinary drugs. Although this information is already included in Sections 55 and 56 of Health Canada Form HC/SC 3011, we are requesting it in order to collect information on all the medicinal and non-medicinal animal-sourced ingredients for the purpose of TSE risk assessment and mitigation.

How will the information be used? Will it be made publicly accessible?

Health Canada will maintain this information in a database to facilitate easy access of information in the event of a public health emergency; this information will not be publicly accessible, and Health Canada will ensure the confidentiality of all proprietary information. Information will only be released in accordance with the Access to Information Act and Privacy Act (i.e., in consultation with, and with agreement of, the owner of the information).

When is this information required?

Manufacturers/sponsors of veterinary drug products containing animal-sourced ingredients indicated for food-producing animals should send in the completed (printed and signed) AIF-NDS to the address noted at the end of this document along with their new drug submission applications.

Does this affect all my products?

All new veterinary drugs submissions that contain animal-sourced ingredients and are indicated for food-producing animals are affected by this request.

Will the submission of the AIF-NDS affect the availability of the drug on the market?

Submission of the AIF-NDS will not affect your ability to obtain a Notice of Compliance and/or a Supplemental Notice of Compliance, provided that the product complies with safety, efficacy, and quality requirements as listed in the VDD new drug submission guidelines. Any VDD concerns resulting from the submission of new information will be dealt with on a case-by-case basis.

Does a veterinary drug/medical device combination require an AIF-NDS?

Yes, you are required to submit an AIF-NDS for the drug product ingredient in your veterinary medical device.

Will any additional studies be requested of me?

VDD will request additional information if deemed necessary.

How should the VDD be notified of changes in ingredient sources?

If the change is from a non-animal to an animal source, notification of this change must be given to the VDD within 30 days by completing Section 3, 4, 5 and 6 of the AIF-NDS. The revised section should be sent to the address noted at the end of this document.

What is Health Canada's legal authority to seek information on animal-sourced ingredients?

The manufacturer/sponsor shall have information regarding the composition of ingredients used in drug products. In accordance with the Food and Drugs Act and Regulations , Division 8 (New Drugs), C.08.002(2), the new drug submission must contain information pertaining to all ingredients and the "specifications for each of those ingredients" (c), the entire manufacturing process (e), and "details of the tests to be applied to control the potency, purity, stability and safety of the new drug" (f). In addition, Health Canada may also ask for" any additional information or material respecting the safety and effectiveness of the new drug" [C.08.002(3)(d)], and may withhold the issuance of the Notice of Compliance or of the Supplemental Notice of Compliance until all safety requirements are met. This may include the use of TSE infectivity free animal-sourced materials or alternative ingredients to mitigate potential health risks caused by transmission of TSE through veterinary drugs (C.08.004).

What is the process to follow in case of unknown sources of ingredients?

Sufficient lead-in time will be given to allow appropriate research and trace-back to determine the presence of materials originating from non-bovine sources, such as other ruminants, swine or chickens.

What is the process to follow if the product is licensed from another manufacturer and information on sources of ingredients is unknown to the distributor?

In cases where another manufacturer is responsible for the fabrication of a product, the manufacturer may provide Health Canada with the information on animal-derived material(s) on behalf of the sponsor. The Third Party Signing Authorization Form, included in Appendix 3 of the AIF-NDS, shall accompany this information.

Is an AIF-NDS required for each individual ingredient?

Yes, please complete the AIF-NDS for each drug product and please complete multiple sections 4, 5, and 6 for additional animal-sourced ingredients.

How does the CFIA categorize countries with regards to risk factors and BSE?

For more information please refer to the CFIABSE import policy for bovine animals and their products, December 2005, available at: http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2005-9e.shtml .

Is there a preferred terminology for non-medicinal ingredients?

Please refer to the document "Non-Medicinal Ingredients Nomenclature" for preferred terminology. This document is available at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/
guide-ld/nonmedingred/nmi_inm-eng.php .

How should the information be provided?

Please complete the AIF-NDS either electronically or with a typewriter and send the completed (printed and signed) AIF-NDS to the following address:

Attn: Sunaina Sharma
Manufacturing and Chemical Evaluation Division
Veterinary Drugs Directorate, Health Canada
Health Products and Food Branch
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue , A.L. 3000A
Ottawa , ON K1A 0K9
Tel: (613) 957-5657 Fax: (613) 957-3861
e-mail: sunaina_sharma@hc-sc.gc.ca

APPENDIX 3 - FOR EACH PRODUCT

Template Authorization for a Third Party to Sign/File an Animal Ingredient Form on Behalf of the Manufacturer/Sponsor/ Supplier Company²⁵

I,     authorize

   (third party person)

of    (name of product)

to file an Animal Ingredient Form for New Drug Submissions (AIF-NDS)

for   (third party company name)

on behalf of   (manufacturer /

sponsor company (Section 1 on Form))

Signed:

Print name:

Title:

Manufacturer/Sponsor Company:

Date:

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¹ Please see Appendix 1 for instructions for the AIF-NDS and Appendix 2 for Questions and Answers.
² A "new drug" is a substance for which information is required to be submitted by the manufacturer to establish the quality, safety and efficacy of the drug product. For a more elaborate definition of "new drug", please refer to the Food and Drugs Act and Regulations.
³ If the signing official is a third party acting on behalf of the manufacturer/sponsor's company, a letter of authorization (available in Appendix 3) must be signed by the manufacturer/sponsor and sent with the completed AIF-NDS.
⁴ The information on medicinal and non-medicinal ingredients is comparable to Sections 55 and 56 in the Health Canada/Santé Canada Form 3011.
⁵ Any substance or mixture of substances intended to be used in the manufacture of a veterinary therapeutic product and that when used in the production of such a product becomes an active ingredient of that veterinary therapeutic product.
⁶ Any substance or mixture of substances intended to be used in the manufacture of a veterinary therapeutic product and that when used in the production of such a product does not become an active ingredient of that veterinary therapeutic product and does not have intended pharmacological effects in the prescribed dose.
⁷ Any component of a finished dosage form that does not have medicinal properties and does not impart pharmacological activities.
⁸ Raw materials which are intended to be used as a processing aid in the fabrication of the final veterinary therapeutic product. These materials may be absent from the final therapeutic product or may remain as an impurity in the final therapeutic product at the end of the manufacturing process.
⁹ The cell lines may not be a part of the final drug product; rather, they may be used in culture or during fermentation and/or manufacturing processes.
¹⁰ For example, amino acids and/or small peptides sourced from hydrolyzate of animal tissues used as synthetic block(s) in the manufacture of the peptidal drug substances, or enzymes used in biosynthesis of biopharmaceuticals.
¹¹ For example ossein, bone ash, bone charcoal, bone oil, oleosterin, triglycerides, glycerol, dried processed ears, pizzles, hooves and tendons.
¹² For more information, please refer to the Food Directorate Policy on Specified Risk Material (SRM) in the Food Supply, available at: http://www.hc-sc.gc.ca/fn-an/securit/animal/bse-esb/policy_srm-politique_mrs-eng.php .
¹³ For more information on different types of animal-sourced materials obtained from animals infected with Transmissible Spongiform Encephalopathy (TSE) possessing varying levels of infectivity, please refer to the Canadian Food Inspection Agency, CFIA Industry Fact Sheet: Specified Risk Materials, available at: http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/specrisinde.shtml .
¹⁴ For more information, please refer to the European Agency for the Evaluation of Medicinal Products, EMEA Notice for Guidance 5.2.8 available at: http://www.emea.eu.int/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf .
¹⁵ For example, pancreatic enzyme digests of casein.
¹⁶ Derivatives of wool and hair of ruminants, such as lanolin, wool alcohols and amino acids sourced from live animals are excluded.
¹⁷ Food-producing animals are animals bred, raised, kept, or slaughtered specifically for the purpose of producing food for human consumption. In Canada , food-producing animals include, but are not limited to, cattle, pigs, sheep, poultry, aquaculture and bees.
¹⁸ For classification of countries or zones according to their Bovine Spongiform Encephalopathy (BSE) status, please refer to the CFIA Import Policy December 2005, available at: http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2005-9e.shtml .
¹⁹ The Office International Des Epizooties (OIE) has developed a classification of countries or zones according to their BSE status. The most recent version of the OIE International Annual Health Code Chapter on BSE is available at: http://www.oie.int/eng/en_index.htm .
²⁰ In Canada, SRMs include the brain, skull, trigeminal ganglia, cornea, tonsils, spinal cord, dorsal root ganglia of cattle 30 months or older and the distal ileum of cattle of all ages. For more information, please refer to the Regulations Amending the Health of Animals Regulations, available at: http://www.inspection.gc.ca/english/reg/consultation/20069_e.shtml and the Regulations Amending the Food and Drugs Act and Regulations (1389-Specified Risk Material), available at: http://canadagazette.gc.ca/partII/2003/20030813/html/sor265-e.html . These amendments do not apply to food that originates from a country that is designated by the CFIA as being free from BSE.
²¹ For classification of animal-sourced material according to its level of infectivity, please refer to the EMEA Note for Guidance 5.2.8., available at: http://www.emea.eu.int/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf. The classification of tissues, fluids and/or macromolecules in the EMEA note is based on titration of infectivity in mice by the intracerebral route and may differ in experimental models using strains adapted to laboratory animals.
²² The potential risk of cross-contamination will be influenced by the circumstances in which tissues, fluids and/or macromolecules were removed, especially when materials from a low-risk group are in contact with materials from a high-risk group. Thus, the risk of cross-contamination of some tissues may be increased if infected animals are slaughtered by penetrative brain stunning or if the brain and/or spinal cord is sawed. The risk of cross-contamination will decrease if body fluids are collected with minimal damage to tissues, if cellular components are removed, and if fetal blood is collected without contamination from other maternal or fetal tissues including placenta, amniotic and allantoic fluids.
²³For example, materials which come into direct contact with the equipment used in manufacture, and therefore have the potential to allow contamination, are included as well.
²⁴ Certificates of Suitability (CoS), as means of demonstrating compliance for those starting or raw materials that are covered by the European Pharmacopoeia Monograph, "Products with Risk of Transmitting Agents of Animal Spongiform Encephalopathies", are acceptable in lieu of a science-based risk assessment for certain products.
²⁵ Submit with the AIF-NDS only if party signing the Form is a third party acting on behalf of the manufacturer/sponsor company identified in Section 1. A separate authorization is required for each product.