Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation

Date: 2013-05-29

The attached Drug Submission Application form is designed to assist manufacturers and sponsors in submitting information required to initiate the evaluation of any one of the following types of submissions:

• Clinical Trial Application (CTA) (human drugs)
• Clinical Trial Application Amendment (CTA-A) (human drugs)
• Veterinary Investigational New Drug (VIND) (veterinary drugs)
• Veterinary Investigational New Drug --Amendment (VIND-AM) (veterinary drugs)
• New Drug Submission (NDS)
• Supplement to a New Drug Submission (SNDS)
• Abbreviated New Drug Submission (ANDS)
• Supplement to a Abbreviated New Drug Submission (SANDS)
• Notifiable Change (NC)
• Drug Identification Number (DIN) Application (Division 1)
• Post-Authorization Division 1 Change
• Administrative Change (only applies to manufacturer/sponsor and/or product name change and licensing agreements).

The attached Guidance Document provides instructions on each field of the form. Please read it in its entirety prior to completing the form.

For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. For all other submission types, only a separate completed Part 2 must be provided for each formulation, strength and dosage form.

Note: Additional or supplementary information for a submission already filed need only be accompanied by a copy of the letter from Health Canada requesting additional information.

Where to send Drug Submission Applications

Human Drugs:

Clinical Trial Applications and Amendments must be sent directly to the applicable Directorate (see attached Guidance Document for addresses)

All other drug submission types are to be sent to:
Submission and Information Policy Division
Therapeutic Products Directorate
Finance Building
101 Tunney's Pasture Driveway, Address Locator: 0201A1
Ottawa, Ontario, Canada
K1A 0K9
Fax: (613) 941-0825

Veterinary Drugs:

All veterinary drug submissions (including Investigational New Drug Submissions and amendments) are to be sent to:
Veterinary Drugs Directorate
Holland Cross Complex
11 Holland Avenue, Suite 14, Address Locator: 3000A
Ottawa, Ontario, Canada
K1A 0K9
Fax: (613) 946-1125

Drug Submission Application

Part 1 - Manufacturer/Sponsor and Drug Product Information

Health Canada Use Only:

1. Submission Number

2. Responsible Area

3. File Number

4. Date of Receipt YYYY MM DD

5. Type of Submission

6. Number of Volumes

7. Schedule

8. Brand or Proprietary or Product Name (should be the same as the brand name on the product label):

9. Proper, Common or Non-Proprietary Name

A) Manufacturer/Sponsor (In cases where a DIN/NOC is issued, this will be the DIN/NOC OWNER) (For CTA, CTA-A, VIND and VIND-AM, refer to attached Guidance)

10. Company Code

11. Manufacturer/Sponsor Name (Full Name - No Abbreviations):

12. Street/Suite

13. City/Town

14. Prov./State

15. Country

16. Postal/ZIP Code

Contact Person for Manufacturer/Sponsor (In cases where a DIN/NOC is issued, this is the DIN/NOC OWNER contact)

17. Name

18. Telephone Number

19. Fax Number

20. Language Preferred
English French

21. Title

22. E-mail

B) Contact for THIS Drug Submission

23. Company Name (Full Name - No Abbreviations)

24. Street/Suite/Post Office Box

25. City/Town

26. Prov./State

27. Country

28. Postal/ZIP Code

39. Name

30. Telephone Number

31. Fax Number

32. Language Preferred
English French

33. Title

34. E-mail

C) Regulatory Mailing Address (Complete where a DIN is to be issued, see attached Guidance)

Same as A Above
N/A (Not Applicable)

35. Company Name (Full Name - No Abbreviations)

36. Street/Suite/Post Office Box

37. City/Town

38. Prov./State

39. Country

40. Postal/ZIP Code

Regulatory Mailing Contact

Same as C Above

41. Name

42. Telephone Number

43. Fax Number

44. Language Preferred
English French

45. Title

46. E-mail

D) Canadian Importer (ONLY where Address in A is not in Canada. EXCEPTION for CTAs, see footnote)^{Footnote 1}

Same as C Above

47. Name of Importer (Full Name - No Abbreviations)

48. Street/Suite/Post Office Box

49. City/Town

50. Prov./State

51. Country
CANADA

52. Postal/ZIP Code

E) Address to which the Drug Notification Form (DNF)/ Notice of Compliance (NOC) are to be sent:

As Above: A: B: C: D: Not Applicable:

53. Related Submissions (referred to in this submission):

A) Type

Control Number

Brand Name

Manufacturer/Sponsor Name

File Number

Date Cleared

Associated DIN(s) :
Reason for Submission:

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

Part 2 - Drug Product Formulation Information

54. Proposed Shelf Life ? years ? months at ? °C.

55. Country of Manufacture

56. Medicinal (Active) Ingredient(s) - If the ingredient was sourced from Animal/Human, complete and submit Appendix 4.

• CAS No. (if applicable)
• Ingredient Name
• Standard
• Strength
• Units
• Per
• Calculated as Base?
  • Yes
  • No
• Animal/ Human Source
  • Yes
  • No

57. Non-medicinal Ingredient(s) - If the ingredient was sourced from Animal/Human, complete and submit Appendix 4.

For formulation variations pertaining to the same DIN (for example [e.g.] multiple flavourings, colours, fragrances), fill out the variant name and list all the non-medicinal ingredients for each variant type.

Variant Type [if applicable]:

• CAS No. (if applicable)
• Ingredient Name
  1. Preservatives
  2. Colouring Agents
  3. Other^{Footnote 2}
  4. Capsule Shell Ingredients (if applicable)
• Standard
• Strength
• Units
• Per
• Calculated as Base?
  • Yes
  • No
• Animal/ Human Source
  • Yes
  • No

58. Animal and/or Human Sourced Material(s) Used at Any Stage in the Manufacture of the Drug - If the material was sourced from Animal/Human, complete and submit Appendix 4.

• CAS No. (if applicable)
• Material Name
• Standard
• Present in Final Container
  • Yes
  • No

59. Is any ingredient listed under Section 56 or 57 a Nanomaterial?
Yes  No
If Yes, Name of the Ingredient:

60. Dosage Form

61. Container Type
Package Size

62. Therapeutic/Pharmacological Classification

63. Route(s) of Administration

64. Drug Product
Biologic / Radiopharmaceutical
Pharmaceutical
Disinfectant
Drug & Medical Device

65. Drug Use
Human [ Paediatric (0-18 years of age) Adult ]
Radiopharmaceutical
Veterinary
Disinfectant [ Hospital  Food Processing Medical Instruments Domestic Barn Institutional/Industrial Contact Lens ]

66. Is this a Non-prescription Drug to which one or more Schedule A claims Apply?
Yes No
If Yes complete and attach the Schedule A form (Appendix 5) .

67. Proposed Indication/Use

68. Proposed Dosage (by age / species - include maximum daily dose)

69. Draft of Proposed Canadian Labels* enclosed?
Yes No
Package Insert enclosed?
Yes No

For CTAs, CTA-As, VINDs and VIND-AMs labels should not be submitted unless requested by the appropriate Directorate.

70. Rationale for all SNDS, SANDS, (all human drug types); Veterinary Supplemental New Drug Submission (VSNDS), Veterinary Supplemental Abbreviated New Drug Submission (VSANDS) (all veterinary drug types); or for biological drug DIN submissions

• New route of administration, dosage form and/or strength
• New claims/use, indications, recommended administration or dosage regime
• Change in formulation or method of manufacturing with clinical/bio data
• Change in drug substance/product (site, method, equipment, process control)
• Replace sterility test with process parametric release
• Confirmatory studies
• Other (please specify):

71. Type of Notifiable Change (NC) or Veterinary Notifiable Change (VNC) submission (if applicable)

• Change in text of labelling
• Change in drug substance (source, synthesis)
• Change in formulation
• Change in specifications (medicinal or non-medicinal ingredient, pharmaceutical form, analytical method)?
• Change in expiry period/storage conditions
• Change in manufacturing method
• Change in manufacturing site
• Change in container size for parenteral drug
• Change in packaging specifications for parenteral/inhalation drug
• Change in packaging material composition
• Other (specify)

Complete Sections 75 - 77 for Veterinary Products only

72. Species and Subtypes Recommended for use

73. Used for treatment of food-producing animals?
Yes No

74. Withdrawal Time
Species
Days
Hours

I, the undersigned, certify that the information and material included in this drug submission application is accurate and complete^{Footnote 3}.

75. Name of Authorized Signing Official

76. Signature

77. Date
YYYY MM DD

78. Title

79. Telephone Number

80. Fax Number

81. Name of Company to which the Authorised Signing Official Belongs

Appendix 1 - for Clinical Trial Applications and Amendments only

Template Authorisation for a Third Party to Import the
New Drug Described in this Clinical Trial Application or Amendment^{Footnote 4}.

I, authorize (list each applicable importer [name and address],
add more space as necessary or attach a list of importers)

attached list of importers
Yes No

to import the new drug for the purposes of the clinical trial described within this application.

Signed: .

Print name: .

Title: .

Clinical Trial Sponsor: .

Date: .

Appendix 2 - For All Applications

Template Authorisation for a Third Party To Sign/File a Drug Submission
Application on Behalf of the Manufacturer/Sponsor^{Footnote 5}.

I, authorize . (third party person)
of to file a drug submission (third party company name)
application for on behalf of (name of product)
(Manufacturer / Sponsor - Section 11 on application)

Signed: .

Print name: .

Title: .

Manufacturer/ Sponsor: .

Date: .

Appendix 3 - Clinical Trial Application Information

(for clinical trial applications for human drugs only)

82. Clinical Trial Protocol Number (must be Assigned)

83. Clinical Trial Protocol Title

84. Is the investigational product obtained from the Canadian market? Yes
No

DIN(s)
Country(ies) obtained:

85. Anticipated Clinical Trial Composition (check all that apply):
Paediatric population (0-18 years of age) Females Males
Adult population Females Males

86. Phase of Clinical Trial (check appropriate box):
Phase I - bioequivalence study (7 day administrative target)
Phase I - study in healthy humans (30-day default)
Phase I - other (30 day default)
Phase II (30 day default)
Phase III (30 day default)
Other - specify:

87. Information regarding Research Ethics Board that has refused to approve the protocol and/or informed consent form enclosed?
Yes No Not Applicable Not known at this time

88. Clinical Trial Site Information Form enclosed for all sites known at time of application?
Yes No No sites are known at this time

In respect of the clinical trial identified in Appendix 3 of this Drug Submission Application form we certify that:

1. The information and material contained in, or referenced by, this application are complete and accurate and are not false or misleading.
2. If requested by Health Canada, additional information or samples required to assess this application will be provided within two calendar days following receipt of the request from Health Canada.
3. The clinical trial will be conducted and the drug used in accordance with the protocol and the requirements set out in Division 5 of the Food and Drug Regulations. The clinical trial will be conducted in accordance with good clinical practices.
4. The trial or amendment will not commence at any site until receipt of a No Objection Letter from the Therapeutic Products Directorate or the Biologics and Genetic Therapies Directorate of Health Canada, or the elapse of 30 calendar days following receipt of the complete application by Health Canada, whichever comes first, and the receipt of the Research Ethics Board Approval.
5. Records will be maintained for a period of 25 years and will be accessible for on-site inspection by Health Canada Inspectors.

89. Senior Medical Officer or Scientific Officer in Canada
90. Tel. Number and Address
91. Signature
92. Date
YYYY MM DD

93. Senior Executive Officer
94. Tel. Number
95. Signature
96. Date
YYYY MM DD

Appendix 4 - Drug Product Formulation Information - Animal and/or Human-Sourced Ingredients / Materials

If you have checked "No" for all the questions listed in section 56, 57, and 58, thereby indicating that there are no animal and/or human-sourced ingredients, then do not complete this appendix.

Please complete a separate Appendix 4 for each individual ingredient and/or material used at any stage in the manufacture of the drug product that was identified as animal and/or human-sourced in 'Part 2 - Drug Product Formulation Information' of the Drug Submission Application form.

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

97. Ingredient/Material Name:

98. Used As:

• Medicinal (Active) Ingredient
• Non-Medicinal Ingredient
• Material used at any stage in the Manufacture of the drug

99. Sourced from:

• Human
• Animal
  Animal Species (please specify)

• Non-human primates
• Aquatic species such as fish, molluscs and crustaceans
• Avian such as chicken, turkey and duck
• Bovine such as cattle, bison
• Canine
• Caprine such as goat
• Cervidae such as deer, elk (wapiti) and moose
• Equine such as horse
• Feline such as cat
• Ovine
• Porcine such as pig
• Rodents such as mouse, hamster, rat and rabbit
• Other

Controlled population
Yes
No

Biotechnology-Derived Animal
Yes
No

Cell Line
Yes
No

100. Tissues or Fluids of Origin:

Nervous system

brain

brain stem

cerebellum

cerebrospinal fluid

dorsal root ganglia

dura mater

hypothalamus

retina/optic nerve

spinal cord

trigeminal ganglia

other (please specify)

Digestive system

appendix

bile

distal ileum

large intestine

saliva/salivary gland

small intestine other than

distal ileum

stomach

other (please specify)

Reproductive and urinary systems

colostrum

kidney

mammary glands

milk/milk products

ovaries

placenta

placental fluid

semen

testes

urine

other (please specify)

Cardio-respiratory system

heart/pericardium

lung

nasal fluid

trachea

other (please specify)

Immune system

lymph nodes

spleen

thymus

tonsils

other (please specify)

Skin and glandular system

adrenal gland or tissue

hair, feathers, hooves

liver

pancreas

pituitary gland

skin/hides

thyroid/parathyroid

other (please specify)

Musculo-skeletal system

abdomen

bones (other than vertebral column and skull)

collagen

muscle (please specify)

skull

tendons/ligaments

vertebral column

other (please specify)

Other tissues or Fluids of origin:

adipose tissue/omentum (please specify)

ascites

antler velvet

serum

whole blood

plasma

embryonic tissue

fetal tissue

bone marrow

eyes/cornea

gall bladder

other (please specify)

101. Age of animals (in months):

102. Country/Countries of origin of animal(s):

Appendix 5 - Schedule A Form for Nonprescription Products

(excluding Natural Health Products)

Please note that this form is only to be completed for nonprescription products that have associated Schedule A claims.

Part A - Drug Product Identification

103. Manufacturer/Sponsor:

104. Product Name:

105. Drug Identification Number (DIN), if issued:

Part B - Schedule A Information

106. Please check the disease(s)/disorder(s) that apply to the claims made.

• Acute alcoholism
• Acute anxiety state
• Acute infectious respiratory syndromes
• Acute inflammatory and debilitating arthritis
• Acute psychotic conditions
• Addiction (except nicotine addiction)
• Appendicitis
• Arteriosclerosis
• Asthma
• Cancer
• Congestive heart failure
• Convulsions
• Dementia
• Depression
• Diabetes
• Gangrene
• Glaucoma
• Haematologic bleeding disorders
• Hepatitis
• Hypertension
• Nausea and vomiting of pregnancy
• Obesity
• Rheumatic fever
• Septicemia
• Sexually transmitted diseases
• Strangulated hernia
• Thrombotic and Embolic disorders
• Thyroid disease
• Ulcer of the gastro-intestinal tract

Part C - Schedule A Claims/Indications

107. Please list the Schedule A Claims/Indications associated with this product:

Guidance for Completing the Drug Submission Application Form

Section #Cover page

Guidance

Clinical Trial Applications and Amendments for human drugs should be sent directly to the applicable Directorate as follows:

Pharmaceutical Drugs
Office of Clinical Trials
Therapeutic Products Directorate
5^th Floor, Holland Cross, Tower B
Address Locator: 3105A
1600 Scott Street
Ottawa, Ontario, Canada
K1A 0K9 K1A 0K9

Biological/Radiopharmaceutical Drugs
Biologics and Genetic Therapies Directorate
Regulatory Affairs Division
Health Canada
Address Locator: 0701A
200 Tunney's Pasture Driveway
Ottawa, Ontario, Canada
K1A 0K9

Investigational New Drug Submissions and amendments and all other submissions for Veterinary Drugs should be sent directly to the Veterinary Drugs Directorate as indicated on the cover page.

Part 1 - Manufacturer/Sponsor and Drug Product Information

Section #1-4

Guidance
Health Canada Use Only

Section #5

The type of submission being presented to Health Canada. Allowable entries are:

1. CTA (Clinical Trial Application)
2. CTA-A (Clinical Trial Application Amendment)
3. NDS (New Drug Submission)
4. SNDS (Supplemental New Drug Submission)
5. ANDS (Abbreviated New Drug Submission)
6. SANDS (Supplemental Abbreviated New Drug Submission)
7. NC (Notifiable Change)
8. DIN (Drug Identification Number submission - all types^{Footnote 6}.)
9. PDC (Post-Authorization Division 1 Change^{Footnote 7})
10. ADMIN (Administrative manufacturer name/product name change/licensing agreements)
11. VIND (Veterinary Investigational New Drug)
12. VIND-AM (Veterinary Investigational New Drug Amendment)
13. VNDS (Veterinary New Drug Submission)
14. VSNDS (Veterinary Supplemental New Drug Submission)
15. VANDS (Veterinary Abbreviated New Drug Submission)
16. VSANDS (Veterinary Supplemental Abbreviated New Drug Submission)
17. VNC (Veterinary Notifiable Change)
18. VDIN (Veterinary Drug Identification Number submission - all types^{Footnote 8})
19. VPDC (Veterinary Post-Authorization Division 1 Change^{Footnote 7})
20. VADMIN (Veterinary Administrative manufacturer name/product name change/licensing agreements)

Section #6

Guidance

Where applicable, state the number of volumes contained in the drug submission. Indicate the number of original volumes, followed by the number of duplicate volumes.

Section #7

Guidance

Schedule: Complete only if the drug is included in Schedule C (radiopharmaceuticals) and/or Schedule D (biologicals) to the Food and Drugs Act, Schedule F (prescription drugs) to the Food and Drug Regulations and please identify if the product falls under the Controlled Drugs and Substances Act (CDSA).

Section #8

Guidance

The brand or proprietary or product name is the name assigned by the manufacturer/sponsor to distinguish the drug (product) and under which the drug is to be sold/advertised. The brand name is also the name used to identify the product in all correspondence related to the submission and on the product label(s) and Product Monograph/Package Insert if applicable. If the brand name has not yet been determined, e.g. CTA, VIND, or NDS submissions, the proper or common name of the drug or the research code may be used.

For a clinical trial submission please enter the name of the investigational product, and where there is more than one investigational product, all of them should be captured and a separate Part 2 should be completed for each one of them. (Note: an investigational product corresponds to a product involved in the conduct of a clinical trial. It could be a product not available in Canada, a product in development or a product already approved in Canada but used outside the approved indication.)

If after filing a NDS, ANDS, DIN, VNDS, VANDS or VDIN submission, but prior to completion of submission review, you wish to change the brand name identified in the filed application form, submit written notice of the proposed change to the same address to which the original application was sent (see cover page), with a note of the submission number and original product name. If you wish to change the product name after the submission has been cleared, refer to the Health Canada policy 'Changes in Manufacturer's Name and/or Product Name'.

Section #9

Guidance

The proper name for a product is the name assigned to the drug in Section C.01.002 of the Food and Drug Regulations, or in boldface type in other Sections of the Regulations or the name of the drug in its finished form identified in the title of a monograph or in any of the official publications listed in Schedule B to the Food and Drugs Act.
Example: Acetaminophen
Ferrous Sulphate Tablets

The common name is the name by which a single ingredient drug is commonly known/designated in scientific or technical journals other than the publications referred to in Schedule B to the Food and Drugs Act. The common name includes the pharmaceutical form when used in relation to the finished drug product.

If there is no proper name and the drug is comprised of a single medicinal ingredient, enter the common name. If there is no proper name and the drug is comprised of more than one medicinal ingredient, leave Section 9 blank. For a clinical trial all the active substances should be listed. If the product comprises more than one ingredient, the proper name of the ingredients should be captured and separated by a slash (/).

Section #
Block A

Guidance

Manufacturer/Sponsor Information: The information to be provided in Block A (10-23) pertains to the manufacturer/sponsor in whose name the drug submission is filed and, where a Drug Identification Number (DIN)/Notice of Compliance (NOC) is to be issued, the company in whose name the DIN/NOC will be registered, (i.e., the DIN/NOC owner) and whose name must be included on the product label and Product Monograph/Package Insert.

For CTAs and CTA-As, sponsor is defined by Division 5, Part C of the Food and Drug Regulations as the individual, corporate body, institution or organization that conducts a clinical trial. Indicate the full name of the sponsor in whose name the subject CTA or CTA-A is being filed. Do not abbreviate the sponsor's name. Note that the sponsor is not necessarily the company that fabricates the drug product. For Investigator-initiated CTAs and CTA-As: if the sponsor is defined as an individual, please also indicate the name of the affiliated institution/organization

For VINDs and VIND-AMs, the same definition of sponsor applies.

Section #10

Guidance

Company code: Where known, enter the 4- or 5- digit company code assigned by Health Canada, to the manufacturer/sponsor company e.g. 4567. If not known, leave blank.

Section #11

Guidance

Indicate the full name of the manufacturer/sponsor in whose name the subject drug submission is being filed and, where applicable, in whose name the DIN/NOC is to be registered. Do not abbreviate the company name. Note that the manufacturer/sponsor is not necessarily the company that fabricates the drug product. Please be advised not to use the wording or abbreviation " dba - doing business as" in the Manufacturer/sponsor name e.g. Hamilton Brothers dba Hamilton Family, they either go with Hamilton Brothers or Hamilton Family or they can go with Hamilton Brothers a division of Hamilton Family.

If after filing a NDS, ANDS, DIN, VNDS, VANDS or VDIN submission and prior to completion of submission review, you wish to change the manufacturer/sponsor name, submit written notice of the change to the same address to which the original application was sent (see cover page), with a note of the submission number and original manufacturer/sponsor name. If you wish to change the manufacturer/sponsor name after the submission has been cleared, refer to the Health Canada policy 'Changes in Manufacturer's Name and/or Product Name'. Note also that such an Administrative Change submission that cross-references the original NDS, ANDS, VNDS or VANDS must be submitted and cleared before changing the manufacturer/sponsor name for an already filed SNDS, SANDS, NC, VSNDS , VSANDS, or VNC submission

For CTAs and CTA-As, sponsor is defined by Division 5, Part C of the Food and Drug Regulations as the individual, corporate body, institution or organization that conducts a clinical trial. Indicate the full name of the sponsor in whose name the subject CTA or CTA-A is being filed. Do not abbreviate the sponsor's name.
Note that the sponsor is not necessarily the company that fabricates the drug product. For Investigator-initiated CTAs and CTA-As: if the sponsor is defined as an individual, please also indicate the name of the affiliated institution/organization. For VINDs and VIND-AMs, the same definition of sponsor applies.

Section #12-16

Guidance

Provide the full mailing address of the manufacturer/sponsor identified in Section 11. If a street address is used, provide the suite/unit number (if applicable) in addition to the street and street number (12), the city/town (13), the province/state (14), the country (15) and the postal or zip code (16). It is not allowed to use a Post Office (PO) Box instead of street/suite to describe the manufacturer's/sponsor's address.

Section #17-22

Guidance

Provide the name of the principal contact (17) located at the address (12-16) of the manufacturer/sponsor company identified in Section 11 and the information needed to contact that individual, i.e., telephone and fax numbers (18-19), position/title (21), e-mail address (22), and if applicable, language preference (20).

Operational and system requirements dictate that this name must be the same for all DINs registered to the manufacturer/sponsor identified in Section 11 where more than one DIN is held by that company. Note that this is NOT necessarily the contact for the subject drug submission but the principal contact for the given manufacturer/sponsor at the address given.

Due to short performance target associated with clinical trials in Canada, this section provides another contact person in case the contact listed in Block B cannot be reached.

Section #
Block B

Guidance

Contact for the subject drug submission: Information provided in Block B (23-34) pertains to the contact specific to the subject drug submission, i.e., the person/company to whom Health Canada should direct correspondence about the subject submission. To avoid confusion, Block B must be completed even if the submission contact is identified under another role.

Section #23

Guidance

Enter the name of the company to which the drug submission contact belongs (i.e., is a staff member). If the contact does not belong to a company, enter the name of the contact.

Section # 24-28

Guidance

Enter the address of the company identified in Section 23. If a street address is used, provide the suite/unit number (if applicable) in addition to the street and street number (24), the city/town (25), the province/state (26), the country (27) and the postal or zip code (28). Include the PO Box number (24) if a post office box is used.

Section #29-34

Guidance

Provide the name of the contact for the subject drug submission (29), i.e., the name of the individual to whom Health Canada should direct correspondence about the subject drug submission.  Provide the information needed to contact that individual, i.e., telephone and fax numbers (30-31), position/title (33), e-mail address (34), and if applicable, language preference (32). Please note that it is the discretion of Health Canada to decide the method of correspondence.

Section #
Block C

Guidance

Regulatory Mailing Address: The information to provide in Block C (35-46) pertains to where and to whom Health Canada should direct regulatory mail other than correspondence specific to the subject drug submission (Block B), e.g. annual notification, regulatory/policy amendment notices as they apply to DINs registered to the manufacturer/sponsor identified in Section 11. Check "Same as A above" or, if different, complete Sections 35-46. Operational and system requirements dictate that the regulatory mailing name/address must be the same for all DINs registered to the manufacturer/sponsor identified in Section 11 where more than one DIN is held by that company.

For CTAs, CTA-As, VINDs and VIND-AMs, check N/A if Block C is not applicable. If N/A has been checked, the remaining fields should be empty.

Section #35

Guidance

Enter the full name of the company who will act on behalf of the manufacturer/sponsor identified in Section 11 with respect to processing of regulatory mail issued by Health Canada e.g. annual notification, regulatory/policy amendment notices as they apply to DINs registered to the manufacturer/sponsor identified in Section 11.

Section #36-40

Guidance

Enter the address of the company identified in Section 36. If a street address is used, provide the suite/unit number (if applicable) in addition to the street and street number (36), the city/town (37), the province/state (38), the country (39) and the postal or zip code (40).  Include the PO Box number (36) if a post office box is used.

Section #41-46

Guidance

Provide the name of the principal contact located at the address identified in Sections 36-40 and the information needed to contact that individual, i.e., telephone and fax numbers (42-43), position/title (45), e-mail address (46), and  if applicable, language preference (44). Please note that it is the discretion of Health Canada to decide the method of correspondence.

Section #
Block D

Canadian Importer: is responsible for the sale of this product in Canada. Complete Block D (47-52) only if the address of the manufacturer/sponsor identified in Sections 11-16 is NOT located in Canada.  If the company is the same as that identified in Section 35, check "Same as C above", or, if different, complete each part of Block D.

Exception for CTAs and CTA-As, if clinical trial drugs are to be imported into Canada, importers should be authorized by the sponsor, regardless of the sponsor’s location.  Appendix 1 should be completed and submitted for each importer in Canada. List each applicable importer authorized to import the new drug for the purposes of the trial outlined in the application. Canadian importer(s) must be located within Canada. Refer to the “Guidance for Clinical Trial Sponsors” for further details. As additional importers are identified, additional copies of Appendix 1 should be provided to Health Canada. If the importer has not changed when a Clinical Trial Application Amendment (CTA-A) is filed, Appendix 1 does not need to be re-submitted.

Section #47

Guidance

Enter the full name of the Canadian Importer. Canadian importer(s) must be located within Canada

Section #48-52

Guidance

Enter the address of the company identified in Section 47. If a street address is used, provide the suite/unit number (if applicable) in addition to the street and street number (48), the city/town (49), the province (50), and the postal code (52).  Do not edit/change the country name "Canada" in section 51.

Section #
Block E

Guidance

If a DIN or NOC is to be issued, indicate to which one of the above addresses the Drug Notification Form (DIN) or NOC should be sent, i.e., the address in Block A, B, C or D. Check all applicable options.

Section #53

Guidance

Where related drug submissions (e.g. a CTA preceding a CTA-A, a CTA preceding a NDS, an NDS relevant to a CTA, the parent NDS for a SNDS or a DIN preceding a PDC) are referenced in the subject drug submission, provide the submission type (see section 5 above), the control number (submission number), the brand name of the drug, the manufacturer/sponsor of the related submission, the file number for the related submission, the date cleared, associated DINs (if any) and the reason for the related submission (e.g. brief protocol description of a CTA, reason for supplement, etc.).

The proper, common or non-proprietary name should be entered if the Brand Name was unknown at the time of the application. Only applications referenced in the subject drug submission should be listed under this section. Duplicate and complete section 53 in its entirety as necessary.

Associated DIN(s): Enter the DINs of the products (if any) that are directly affected by the current submission. This will help locate the product to update any changes, e.g., updating the Product Monograph or other information in Drug Product Database (DPD). If there is no DIN issued for the product, please enter N/A for not applicable.

Part 2 - Drug Product Formulation Information

Section #54

Guidance

The proposed expiry/shelf life is the length of time in years and months up to which the drug product maintains its labelled potency, purity and physical characteristics.

For CTAs, CTA-As, VINDs and VIND-AMs, it is not necessary to fill in this section if the drug product to be used in the clinical trial is marketed in Canada or if the investigational product used is for a Bioequivalence/Bioavailability study.

Section #55

Guidance

Provide the name of the country(ies) where the final dosage form of the drug product is manufactured/fabricated, e.g., if the drug product is in the dosage form of a tablet or solution, enter the country(ies) where the tablet or solution was fabricated. This may not necessarily be the country(ies) where the product is packaged/labeled.

For CTAs, CTA-As, VINDs and VIND-AMs, please indicate N/A if the manufacturer of the investigational product is not the sponsor of the trial.

Section #56

Guidance

List the medicinal (active) ingredient(s) that contribute to the proposed use of the product, by its/their proper or common name(s). Where the standard of manufacture of an ingredient complies with a Schedule B compendial standard, use the applicable abbreviation for that compendium, e.g. United States Pharmacopeia (USP), British Pharmacopoeia (BP). Where the specifications for ingredient manufacture deviate from and exceed or are equivalent to the compendial standard, manufacturer's standard (Mfr Std) may be indicated. Please enter N/A if no compendial standard exists for the active ingredient.

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

• Discrete pharmaceutical forms (e.g. tablet) - g or mg / pharmaceutical form
• Powder for oral use - g or mg/mL, g or mg / dosage unit (e.g. /5mL)
• Liquid for parenteral use - mg/mL or %
• Liquid for oral use - g or mg/mL, g or mg / dosage unit (e.g. /5mL)
• Cream, ointment, lotion, etc. - mg or mL/g, g or mg/mL or %
• Powder for solution, etc. - units/dosage unit (e.g. /20 mL vial)

Examples: (If the ingredient was sourced from Animal/Human, please complete and submit Appendix 4.)

CAS # (if applicable)	Ingredient Name	Standard	Strength	Units	Per	Calculated as Base?		Animal/ Human Source
564-25-0	Doxycycline (as doxycycline hyclate)	USP	100	mg	tablet	Yes	No	Yes	No
86541-74-4	Benazepril Hydrochloride	USP	5	mg	tablet	Yes	No	Yes	No
n/a	Antithrombin III (Human)	n/a	1350 - 1650	IU	vial	Yes	No	Yes	No

In the above examples, the strength of the active moiety doxycycline (supplied as doxycycline hyclate) is declared and is therefore calculated as the base. In the case of benazepril hydrochloride, it is the strength of the salt that is declared and therefore the strength is not calculated as the base.

Identify whether the ingredient was sourced from animal/human. If the ingredient was sourced from Animal/Human, please complete and submit Appendix 4.

For Drug Identification Number applications, a separate HC/SC 3011 must be completed and provided for each formulation and strength.  For all other submission types, only a separate Part 2 must be duplicated, completed, and provided for each formulation and strength. If all the information is the same for the remaining sections then there is no need to repeat these sections for each strength/dosage form.

For example, if the application is for a Division 8 (new drug) with two strengths (i.e.: 5mg and 10mg) and the strength is the only difference affecting Part 2 then only section 56 and 57 should be duplicated.

Section # 57

Guidance

List the non-medicinal ingredient(s) in a similar manner to the medicinal (active) ingredients in section 56 above, except that there is no requirement to indicate whether the ingredient is calculated as the base or salt. List the preservative(s) first followed by the colouring agent(s). The remaining non-medicinal ingredient(s) should go under in Section C - Other, and if applicable, list the ingredients used in capsule shell in Section D. For products regulated solely under Division 1, state the purpose of any non-medicinal ingredients included under Section C - Other on a separate sheet.

For formulation variations pertaining to the same DIN (e.g. multiple flavourings, colours, fragrances), please fill out the variant name and list all the non-medicinal ingredients for each variant type.

Identify whether the ingredient was sourced from animal/human. If the ingredient was sourced from Animal/Human, please complete and submit Appendix 4.

For CTAs, CTA-As, VINDs and VIND-AMs, it is not necessary to fill in this section if the drug product to be used in the clinical trial is marketed in Canada or if the investigational product is meant for any Bioequivalence/Bioavailability studies.

Section #58

Guidance

List the Animal/Human-sourced material(s) for each individual drug product ingredient and/or material used at any stage in the manufacture of the drug product including excipient or processing aid source from human and/or animal tissue.

Enter CAS # (if applicable), Material Name and Standard for the Human/Animal sourced material used in the manufacturing of the product. Select the option Yes for the column "Present in Final Container" if the ingredient is present in the final container (based on the quality standard applicable for the product).

For clinical trial applications for pharmaceutical products, Appendix 4 should not be submitted, provided that the required information or attestations are included in the application.

Section #59

Guidance

Select the appropriate option based on Health Canada's working definition of Nanomaterials:

Health Canada considers any manufactured product, material, substance, ingredient, device, system or structure to be nanomaterial if:

• It is at or within the nanoscale in at least one spatial dimension, or;
• It is smaller or larger than the nanoscale in all spatial dimensions and exhibits one or more nanoscale phenomena.

For the purposes of this definition:

• The term "nanoscale" means 1 to 100 nanometres, inclusive;
• The term "nanoscale phenomena" means properties of the product, material, substance, ingredient, device, system or structure which are attributable to its size and distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,
• The term "manufactured" includes engineering processes and control of matter and processes at the nanoscale.

Section #60

Guidance

Identify the proposed dosage form (pharmaceutical form) of the drug product, e.g. tablet, capsule, cream, powder for solution, etc.

For Drug Identification Number applications, a separate HC/SC 3011 must be completed and provided for each dosage form.  For all other submission types, only a separate Part 2 must be duplicated, completed and provided for each dosage form.

Section #61

Guidance

Identify the type of container(s) to be used and the package size(s) proposed, e.g. bottle, 100 tablets; tube, 50 gm; vial, 5mL.

For CTAs, CTA-As, VINDs and VIND-AMs, please indicate N/A as it is not necessary to fill in this section if the information is unknown at the time of the application.

Section #62

Guidance

Record the appropriate therapeutic and pharmacological classification for the drug, e.g. calcium channel blocker, biological response modifier, histamine H₂-receptor antagonist, disinfectant.

Section #63

Guidance

Indicate the proposed route(s) of administration, e.g. oral, intravenous, topical, etc.  For a disinfectant drug DIN submission, the information collected in this section is its use as mentioned in section 65, so sponsor may enter "Refer section 65" instead of filling out the disinfectant use.

Section #64

Guidance

Indicate whether the drug product is a biologic/radiopharmaceutical, pharmaceutical, disinfectant or a drug and medical device combination. If the product is a drug and medical device combination, also indicate what type of drug it is, e.g. biologic/radiopharmaceutical or pharmaceutical.

Section #65

Guidance

Indicate whether the drug is intended for human (paediatric or adult population - select both if applicable) or veterinary use or as a radiopharmaceutical or as a disinfectant.

Paediatric Populations: is a term defined in the Food and Drug Regulations (C.08.004.1) as follows: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age.

If the product is a disinfectant, indicate whether it is intended for use on Hospital or Food Processing Surfaces or for disinfection/sterilization of Medical Instruments, or Barn or Domestic or for Institutional/Industrial or Contact Lens

Section #66

Guidance

If this is a nonprescription drug (human and/or veterinary) to which one or more Schedule A Claims applies, please complete and submit Appendix 5. For further guidance and information please consult the 'Draft Guidance Document Schedule A and Section 3 to the Food and Drugs Act.

Section #67

Guidance

Indicate the proposed indication/use of the drug, e.g. for use in the treatment of angina and hypertension, to treat the symptoms of hay fever, for the prophylaxis of measles virus infection.

For a new drug, the proposed indication/use shall be a summary of the indication described in the product monograph. Key scientific terminology should be used for this section.

For a disinfectant drug, include one of two options: 1) Hard Surface Disinfectant; or 2) Contact Lens Disinfectant.  Proposed indications as "disinfectant/sanitizer" or "toilet bowl cleaner" are not permitted.

Section #68

Guidance

Specify the proposed dosage of the drug product, including the maximum daily dose, e.g. 1 tablet, four times daily.

Section #69

Guidance

Confirm that the draft labels (inner and outer) for use in Canada, including the Package Insert if there is one, are included in the submission. The draft label does not include the Product Monograph.

For CTAs and CTA-As, VINDs and VIND-AMs, labels should not be submitted unless requested by the appropriate Directorate.

Section #70

Guidance

Complete only if the subject drug submission is a SNDS, SANDS (all human drug types), VSNDS, VSANDS (veterinary drugs) or a biological drug DIN submission. Identify the rationale for filing the subject submission, e.g. new route of administration or pharmaceutical form, additional strength.  Check all applicable options.

Section #71

Guidance

Complete only if the subject submission is a Notifiable Change to a new (human or veterinary) drug. With reference to the Health Canada's "Post-NOC Changes Guidance Document", identify all applicable change(s) to which the subject submission refers.

Section # 72-74

Guidance

Complete Sections 72-74 for veterinary products only

Section #72

Guidance

Specify the species and subtypes for which the drug product is intended, e.g. poultry (species) - laying hens (subtype).

Section #73

Guidance

Indicate whether or not the drug is intended for use in food-producing animals.

Section #74

Guidance

Indicate the proposed withdrawal time for each species identified in Section 72.

Section #75

Guidance

Print the name of the person authorized by the manufacturer/sponsor identified in Section 11 to sign this form, i.e., the person signing the form is certifying that the information provided in the form is consistent with the wishes of the manufacturer/sponsor.

Section #76-77

Guidance

The signature of the authorized signing official (76) and the date the form is signed (year/month/day) (77).

Section #78-80

Guidance

The title of the position held by the authorized signing official (78) and his/her telephone and fax numbers (79-80).

Section #81

Guidance

The name of the company to which the authorized signing official belongs. If the signing official is a third party belonging to a company other than manufacturer/sponsor company identified in Section 11, a letter of authorization signed by the manufacturer/sponsor (section 11) company must be filed with the Drug Submission Application Form (see Appendix 2).

Section # Appendix 1

Guidance

Complete Appendix 1 (or a similar authorization) for clinical trial applications and amendments only.  The form should be completed and submitted if the clinical trial sponsor is authorizing one or more third parties to import clinical trial drugs into Canada. Each importer authorized to import the new drug into Canada for the purposes of the clinical trial described in this application should be listed. As additional importers are identified, additional copies of Appendix 1 should be provided to Health Canada.  If the importer has not changed when a clinical trial application amendment is filed, Appendix 1 does not need to be re-submitted.

A separate HC/SC 3011 and accompanying Appendix 1 should be provided for each protocol.

Section # Appendix 2

Guidance

Complete Appendix 2 (or a similar authorization) only if the party signing the HC/SC 3011 is a third party acting on behalf of the manufacturer/sponsor company identified in section 11.  Note that a separate authorization is required for each application.

Section # Appendix 3

Guidance

Complete Appendix 3 - Clinical Trial Application Information for Clinical Trial Application and Clinical Trial Application Amendments only.  A signed and dated Appendix 3 is required to be joined to the HC/SC 3011 form when submitting a clinical trial or an amendment (clinical or quality) to a previously approved clinical trial.

Section #82

Guidance

Specify the protocol number of the clinical trial. Note that the protocol number should remain the same for the duration of the trial. It is acceptable to indicate the version or amendment number of the protocol submitted at the time of application; however, the original protocol number must always be indicated.

Section #83

Guidance

Specify the clinical trial protocol title.

Section #84

Guidance

For an investigational product involved in the clinical trial, indicate whether or not the Canadian marketed product is being used.  If the Canadian marketed product is being used, please provide the Drug Identification Number (DIN).  If a foreign marketed product is being used, identify the country(ies) from which the product was obtained. If the investigational product is not marketed anywhere, enter N/A.

Section #85

Guidance

Indicate whether the clinical trial is anticipated to include paediatric population, 0-18 years of age, (females and/or males) and/or adult population (females and/or males).

Paediatric Population: is a term defined in the Food and Drug Regulations (C.08.004.1) as follows: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age.

Check all applicable options.

Section #86

Guidance

Specify what phase of clinical trial is being submitted. For additional information, please consult the Guidance for Clinical Trial Sponsors - Clinical Trial Applications.

Section #87

Guidance

If a Research Ethics Board has refused to approve the clinical trial protocol and/or informed consent form, confirm that the information outlined in the "Guidance for Clinical Trial Sponsors" is enclosed in the submission.  If no Research Ethics Board has refused to approve the protocol and/or informed consent form, check N/A for not applicable.  If it is not yet known if a Research Ethics Board has refused, check "Not known at this time".

Section #88

Guidance

A completed Clinical Trial Site Information Form should be enclosed for each proposed clinical trial site known at the time of the application of a clinical trial or amendment. Please do not provide forms until all fields are completed including section 37 and/or 45 of the Clinical Trial Site Information Form.

For all clinical trial site information which becomes available after the time of application, a completed Clinical Trial Site Information Form must be provided to the appropriate Directorate prior to the commencement of the trial.

Section #89-90

Guidance

Print the name of the Senior Medical Officer or Scientific Officer in Canada (89), and his/her telephone number and address (90). This is a scientific or medical officer residing in Canada, representing the sponsor, who is responsible for providing an attestation with respect to the CTA or CTA-A at the time of filing, as outlined in Appendix 3.

Section #91-92

Guidance

The signature of the Senior Medical Officer or Scientific Officer in Canada (91), and the date the form is signed (year/month/day) (92).

Section #93-94

Guidance

Print the name of the sponsor's Senior Executive Officer (93), and his/her telephone number (94).

For institutional/ investigator-initiated clinical trials, the appropriate Department Head may sign in lieu of the Senior Executive Officer.

Section #95-96

Guidance

The signature of the sponsor's Senior Executive Officer (95) and the date the form is signed (year/month/day) (96).

Section # Appendix 4

Guidance

If you have checked "No" for all the questions listed in section 56, 57, and 58, thereby indicating that there are no animal and/or human-sourced ingredients, then do not complete this appendix.

Please complete a separate Appendix 4 for each individual ingredient and/or material used at any stage in the manufacture of the drug product that was identified as animal and/or human-sourced in 'Part 2 - Drug Product Formulation Information' of the Drug Submission Application Form.

For Biologic product, it is allowed to submit human/animal source information for a specific antigen under one branded product as a master then cross reference those in subsequent submissions for different branded products containing the same antigens. In that case the sponsor must indicate cross reference information by stating the brand name, DINs and antigen name on a separate page instead of filling out the human/animal tissue form.

There is no need to re-submit an Appendix 4 for subsequent submission for the same product if there is no change in medicinal, non-medicinal information and its source.

The purpose for requesting additional information on animal source ingredients is to collect relevant data on formulation of the drug products and to make use of this information any time during product life-cycle, if required.

Section #97

Guidance

List the animal- and/or human-sourced medicinal and non-medicinal ingredients and materials used at any stage in the manufacture of the drug product by their proper or common name.

Complete a separate Appendix 4 for each individual drug product ingredient and/or material used at any stage in the manufacture of the drug product that was identified as animal- and/or human-sourced.

Section #98

Guidance

Indicate whether the animal- and/or human-sourced ingredient/material is used as a medicinal (active) ingredient, non-medicinal ingredient, or material used at any stage in the manufacture of the drug product.

Section #99

Guidance

Specify whether the ingredient is sourced from Human and/or Animal(s). For animals, please check the appropriate box and specify the species in the category indicated. For example, if the animal is a cervidae, specify if it is a moose, a deer, an elk, etc.

Controlled Population: Specify whether the ingredient is sourced from an animal(s) belonging to an exclusive population reared specifically with the purpose of controlling disease, or reared specifically for use in the pharmaceutical industry (e.g., relevant certification or standards recognition by national, international or third-party).

Biotechnology-Derived Animal: Specify whether the ingredient is sourced from a biotechnology-derived animal(s).

The Health of Animals Regulations under the Health of Animals Act defines biotechnology as "The application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms".  The term "biotechnology-derived animals" is an extension of the definition of biotechnology.  It refers to animals which have been generated through biotechnological methods. For more information, please refer to the Canadian Food Inspection Agency's "Animal Health Risk Analysis Framework for Biotechnology-Derived Animals".

Section #100

Guidance

Specify tissues and fluids used to source the ingredients.

Section #101

Guidance

Indicate the age of the animal (in months) at the time the tissue/fluid/macromolecule(s) is sourced. It is acceptable to provide a range of ages (in months).

Section #102

Guidance

Indicate all countries in which the animal was born and resided.

The World Organization for Animal Health (OIE) identifies countries according to a BSE Risk Categorization scheme. Drug products containing animal tissue sourced from a "controlled risk" or "undetermined risk" jurisdiction, as defined by the OIE, require a chemistry and manufacturing assessment by Health Canada. Please see the OIE website for more information on BSE risk categorization, available at: www.oie.int

Section Appendix 5

Guidance

Note that this form is ONLY to be completed for nonprescription products excluding natural health products that have associated Schedule A claims. In other words, if section 66 of the form was checked 'YES', please complete and submit Appendix 5. For further guidance and information regarding Schedule A, please consult the 'Draft Guidance Document Schedule A and Section 3 of the Food and Drugs Act'.

Section #103

Guidance

Indicate the manufacturer/sponsor as instructed in section 11 above.

Section #104

Guidance

Indicate the product name as instructed in section 8 above.

Section #105

Guidance

Identify the Drug Identification Number (DIN) if it has already been issued.

Section #106

Guidance

Check all the disease(s)/disorder(s) that apply to the claims made.

Section #107

Guidance

List the Schedule A Claims/Indications associated with the product listed in section 104.