Compendial from generated monograph Electronic Product Licence Application form

Natural Health Products Directorate

Primary Brand Name *:
1. Tracking Number:

Part 1 - Applicant and Contact Information

A - Applicant or Licensee

4 Applicant/Company Name *

5 Company Code

6 Street/Suite/Land Location *

7 City - Town *

8 Province - State *

9 Country *

10 Postal/ZIP Code *

B - Senior Official

11 Name

Salutation *

Surname *

Given Name *

12 Title

13 Language preferred

14 Company Name *

15 Address same as Applicant/Licensee

16 Street/Suite/Land Location *

17 City - Town *

18 Country *

19 Province - State *

20 Postal/ZIP Code *

21 Telephone No. *

Ext.

22 Fax No.

23 E-mail

C - Contact for this Application

24 Contact same as Senior Official

25 Name

Salutation *

Surname *

Given Name *

26 Title

27 Language preferred

28 Company Name *

29 Address same as Applicant/Licensee

30 Street / Suite / Land Location *

31 City - Town *

32 Country *

33 Province - State *

34 Postal/ZIP Code *

35 Telephone No. *

Ext.

36 Fax No.

37 E-mail

D - Representative in Canada

38 Representative in Canada same as Contact

39 Name

Salutation *

Surname *

Given Name *

40 Title

41 Language preferred

42 Company Name

44 Street/Suite/PO Box *

45 City - Town *

46 Country

47 Province - State *

48 Postal/ZIP Code *

49 Telephone No. *

Ext.

50 Fax No.

51 E-mail

E - Contact to whom the Product Licence is to be Sent

52 Contact to Whom Product Licence is to be Sent

Name if Not Applicable

Part 2 - Submission Type

A - Product Licence Application

53 Type of Application *

54 Hypothetical Formulation

E - Submission Content

59a Designated Party Authorization

59a-1  Count of Mail-in Designated Party Authorization Submissions

59b Label Text

59b-1  Count of Mail-in Label Text Submissions *

59b-2  Count of Generated Label Text Attachments *

59b-3  Count of Label Text Attachments *

59d Evidence Summary Report

59d-1  Count of Mail-in Evidence Summary Report Submissions *

59d-2  Count of Evidence Summary Report Attachments *

59e References

59e-1  Count of Mail-in References Submissions *

59e-2  Count of References Attachments *

59f  Safety Summary Report

59f-1   Count of Mail-in Safety Summary Report Submissions *

59f-2   Count of Safety Summary Report Attachments *

59g Quality Summary Report

59g-1  Count of Mail-in Quality Summary Report Submissions *

59g-2  Count of Quality Summary Report Attachments *

59h Other Claim Evidence

59h-1  Count of Mail-in Other Claim Evidence Submissions

59h-2  Count of Other Claim Evidence Attachments

F - Reference Submissions

60 Other Supporting Submission

60a Company Number *

60b File Number *

60c Submission Number *

60d NPN/DIN-HM Number

60e Contains Information to Support *

Safety

Efficacy

Quality

G - NHPD Master File Reference

61 Supporting Master File

61a Master File Number

61b Contains Information to Support

61c Safety Only

61d Efficacy Only

61e Quality Only

61f  Complete Submission

61g Letter of Access Enclosed

Part 3 - Site Information

62 Company Name

64 Number, Street - Suite - PO Box

65 City

66 Country

67 Province - State

68 Postal Code - Zip Code

Part 4 - Product Information

70 Primary Brand Name

71 Other Brand Names

105 Route of Administration *

103 Dosage Form *

104 Sterile *

A - Medicinal Ingredient(s)

Medicinal Ingredient Number

73 Standard or Grade

Ingredient Type *

77a Quantity *

Additional Quantity

77b Unit *

Additional Unit

Ingredient Names

Approved Name *

75 Proper Name *

76 Common Name *

Source

Source Material

Synthetic *

Animal Tissue Used **

B - Non-Medicinal Ingredient

Non-Medicinal Ingredient Number

98 Standard or Grade

Approved Name *

94 Common Name *

95 Purpose *

99a. Quantity

99b. Unit

100 Source Information

79 Animal Tissue Used

C - Ingredient(s) Used in Processing

101 Animal Tissue Used In Processing **

D - Recommended Conditions of Use

102 Recommended Use and Purpose *

Recommended Dose

107 Sub-Population Group

Frequency

Min *

Max *

Dosage

Min *

Max *

Dosage Units *

Additional Dosage Information

112 Directions of Use

Duration of Use

Duration

min

max

neither

106c Duration Statement

Risk Information

113 Cautions and Warnings

114 Contraindications

115 Known Adverse Reactions

Part 5 - Label Text

Attestation

* - denotes mandatory

** - if yes, complete Animal Tissue Form