Notice of Compliance (NOC) Database Terminology

Advisories and Warnings

The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties.

Brand/Product Name

The brand name is the unique name under which the manufacturer of a drug product advertises and sells it.

Canadian Reference Product

1. "a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,
   
   
2. a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada, or
   
   
3. drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph a)".

Drug Product Database (DPD) Online

The Drug Product Database (DPD) contains product-specific information on drugs authorized and marketed for use in Canada. Health Canada manages the database, which includes human pharmaceutical and biological drugs, veterinary drugs and disinfectant products. It contains information on approximately 14,000 products that have been notified to Health Canada as being marketed. It also contains 25,000 products that have been discontinued. Information available in the DPD includes the following parameters: Brand Name, Description, Drug Identification Number (DIN), Manufacturer, Medicinal Ingredient(s), Route of Administration, Pharmaceutical Form, Package Size, Therapeutic Classification (The American Hospital Formulary Service (AHFS) and the Anatomical Therapeutical Chemical (ATC) Classification Systems), Active Ingredient Group (AIG) Number, Pharmaceutical Standard and Veterinary Species.

Drug Identification Number (DIN)

The DIN is an eight-digit numerical code assigned to each drug product authorized for sale under the Food and Drugs Act and Regulations (except for Schedule C drugs [radiopharmaceuticals]).

Form (Pharmaceutical Form)

The pharmaceutical form is the form in which the product is supplied. It is the combination of the form in which a product is presented [for example (e.g.)] in tablet, capsule or powder form, and the physical form in which it is administered, [for example, (e.g.)] in a powder to be administered in solution.

Manufacturer

The company in whose name the drug submission is being filed and, where applicable, in whose name the NOC is to be registered. Note that the manufacturer is not necessarily the company that fabricated the drug product.

Medicinal Ingredient (also referred to as Active Ingredient)

A medicinal ingredient is any component that has medicinal properties, and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.

Notice of Compliance (NOC) Date (yyyy-mm-dd)

This is the date that a particular therapeutic product was granted market authorization by receiving an NOC.

Notice of Compliance (NOC) Extract

This data extract will be a series of compressed ASCII text files of the database. These extracts will contain most of the information currently provided in the NOC listings but formatted differently. The uncompressed size of the files is approximately 2.5 MB. In order to utilize the data, the file must be loaded into an existing database or information system. The NOC Online data extract will be updated weekly on every Friday.

Please note any Portable Document Format ( PDF ) files visible on the NOC Online Database will not be part of the data extracts.

Notice of Compliance (NOC) Listings

Currently this listing is provided in two formats, ASCII text and "comma-delimited" database-text format (DBF). The data is broken down by a Weekly Update, Previous Weekly Updates and Yearly Updates. These listings were the only way to import data into most database software packages. It should be noted that by mid September 2010 these listings will no longer be provided as a new NOC extract file will be provided and all users wanting to import data related to an NOC will be referred to these extract files.

Notice of Compliance with Conditions (NOC/c)

An NOC/c is the authorization to market a drug ([such as (i.e.)] a Notice of Compliance (NOC)), with the condition that the manufacturer carries out more studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy (Notice of Compliance with Conditions: Revised Policy), is issued under section C.08.004 of the Food and Drug Regulations.

Within the NOC Database, where applicable each NOC/c has links to the following documents:

• Dear Health Care Professional Letters (DHCPL),
• Product Specific Fact Sheet, and
• Qualifying Notice.

It should be noted that once a company fulfills the conditions associated with a NOC/c these links to documents will be removed from the database.

Notice of Decision

A Notice of Decision (ND) is a one-page summary outlining the authorization received and general information related to the drug or medical device. NDs will be published independently within approximately two weeks of product authorization. When the Summary Basis of Decision (SBD) is published, the ND will be incorporated into the SBD as Section 2.

Product Monograph Part III : Consumer Information

The Product Monograph Part III: Consumer Information is a lay-language translation of information contained in Parts I (Health Professional Information) and II (Scientific Information) of the product monograph. For more information, refer to the Health Canada guidance document Product Monographs.

For the purposes of the product monograph, "consumer" is defined as the general public. It may include an individual using the drug, a caregiver or someone who is simply interested in obtaining information about a drug.

Product Type

An NOC can be issued for four types of submissions: 1) Prescription Pharmaceutical, 2) Nonprescription Pharmaceutical, 3) Biologics and Radiopharmaceuticals, and 4) Veterinary.

Reason for Supplement

The reason for filing the Supplement to a New Drug Submission (SNDS) or Supplement to an Abbreviated New Drug Submission (SANDS) (see submission class definition, below) is provided in most cases. Reasons may include a new strength, new dosage form or a new indication.

Route (Route of Administration)

This term indicates the part of the body on which, through which or into which the product is to be introduced. (e.g. oral, topical, intramuscular, rectal, etc.)

A product can have more than one route of administration (e.g. intravenous, intramuscular, intra-articular, etc.).

Strength

This term refers to the strength of the medicinal ingredient per dosage unit (e.g. 10 mg/5 mL).

Submission Class

This database indicates whether a submission is a New Active Substance (NAS), Priority NAS Review, or a Priority Review. The submission classes are defined below:

NAS (New Active Substance)

• a chemical or biological substance not previously authorized for sale in Canada as a drug;
• an isomer, derivative or salt of a chemical substance previously authorized for sale as a drug in Canada, but differing in properties with regard to safety and efficacy; and
• a biological substance previously authorized for sale in Canada as a drug, but differing in molecular structure, nature of the source material or manufacturing process.

Priority Review

• The Priority Review of Drug Submissions Policy applies to a New Drug Submission (NDS) or Supplemental New Drug Submission (SNDS) for a serious, life-threatening or severely debilitating¹ illness or condition for which there is substantial evidence of clinical effectiveness that the drug provides:
  • effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
  • a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.

Priority Review - NAS

• This submission class occurs when both of the above are applicable.

Submission Type

The following submission types are listed in this database: New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS) and Supplement to an Abbreviated New Drug Submission (SANDS)

Summary Basis of Decision

A Summary Basis of Decision (SBD) is a document that outlines the scientific and benefit/risk based considerations that factor into Health Canada's decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy and quality (chemistry and manufacturing) considerations.

Therapeutic Class

A drug's Therapeutic Classification (Class) is assigned on the NOC according to its main therapeutic use.

¹Guidance on serious, life-threatening and severely debilitating is outlined in "Guidance for Industry; Priority Review of Drug Submissions".