DIN Submissions

1
DIN Submissions

• PRA700

2
Food and Drugs Regulations

• Section C.01.014 states that no manufacturer
  shall sell a drug in dosage form unless a DIN has
  been assigned for that drug and the assignment of
  the number has not been cancelled pursuant to
  Section C.01.014.6

3
Application for a DIN

• For a new drug, a NDS is filed pursuant to
  Division 8 of FD Regulations is regarded as an
  application for a DIN
• When a product is not subject to Division 8, the
  application is called a DIN submission
• In order to receive a DIN, the sponsor is
  required to prove safety and efficacy of a drug

4
Definition

• An eight (8) digit numerical code
• A DIN identifies the following product
  characteristics
• manufacturer
• brand name
• medicinal ingredient(s)
• strength of medicinal ingredient(s)
• pharmaceutical form
• route of administration
• Each distinct product receives a separate DIN and
  therefore a separate submission is required

5
DD GUIDELINE

• Preparation Of Drug Identification Number
  Submissions - February 22, 1995
• New Draft Guidance currently in progress

6
Scope of the Guideline

• Outlines the information normally needed to
  establish quality, safety and efficacy of drug
  products according to product type
• Basic application and certification requirements
• Additional to the basic information refer to
  section of guideline that applies to the product
  type
• Applicable to all pharmaceutical products for
  human use with the exception of Schedules C D
  drugs and GP products not subject to a Category
  IV Monograph or Labelling Standard

7
Presentation of the Submission

• Drug Submission Application (Appendix A)
  including proposed Canadian labels and
  prescribing information or a package insert where
  applicable
• DIN Submission Certification (Appendix C) or
  Category IV Drug Submission Certification
  (Appendix D) as appropriate
• Specific product type information as specified in
  Sections I - XVII
• Review of the information submitted may result in
  the request for additional material
• Management of Drug Submissions Policy applies to
  DIN submissions

8
Specific Product Information

• Section I Change in Manufacturer's Name and/or
  Address Change in ProductName or
  Cross-Referenced Drug Product
• Section II Homeopathic Preparations
• Section III Traditional Herbal Medicines
• Section IV Disinfectant Drugs
• Section V Nonprescription Products Subject to a
  Category IV Monograph

9
Specific Product Information (continued)

• Section VI Nonprescription Products Subject to a
  Labelling Standard (LS)
• Section VII Solid Oral Dosage Forms, Oral
  Suspensions, Powder/Granules forOral Suspension,
  and Oral Solutions, Intended for Systemic Effect
• Section VIII Modified-Release Oral Dosage Forms
• Section IX Solutions for Inhalation

10
Specific Product Information (continued)

• Section X Injectable Preparations (Aqueous and
  Non-Aqueous Solutions, Powdersfor Injection,
  Suspensions and Emulsions)
• Section XI Peritoneal Dialysis Solutions
• Section XII Hemodialysis Solutions
• Section XIII Ophthalmic Preparations
• Section XIV Rectal Suppositories that Deliver
  Drugs for SystemicAbsorption

11
Specific Product Information (continued)

• Section XV Topical Preparations, Dental Topical,
  Vaginal and NasalPreparations Intended for Local
  Effect
• Section XVI Otic Preparations
• Section XVII Other Products

12
Changes After DIN Issuance

• Annual DIN Notification
• For DINs issued on the basis of a demonstration
  of bioequivalence, comparative pharmacodynamic/cli
  nical studies or pharmaceutical equivalence, any
  change which would have an impact on these
  parameters would cause the previously filed
  information to be no longer correct
• For this reason, such changes would require
  notification and approval prior to implementation
• A working group has been established to develop
  clear guidelines to cover all aspects of changes
  post-DIN issuance

13
Review

• Section V and VI applications allow for an
  expedited review
• Product must follow category IV Monograph as
  outlined
• Attestation to meeting a Labelling Standard
  results in omission of the label review