Guidance on switching from prescription to non-prescription status: Glossary

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• Acronyms
• Definitions
• Dependence, addiction, misuse and abuse terminology

Acronyms

ANDS

abbreviated new drug submission

CDFT

Canadian Drug Facts Table

CDSA

Controlled Drugs and Substances Act

DEL

drug establishment licence

DG

Director General

DIN

drug identification number

DNF

drug notification form

DSM-5

Diagnostic and Statistical Manual of Mental Disorders, 5th edition.

EMA

European Medicines Agency

FDR

Food and Drug Regulations

GMP

good manufacturing practices

ICH

International Conference on Harmonisation

MDR

Medical Device Regulations

MedDRA

Medical Dictionary for Regulatory Activities

NDS

new drug submission

NHP

natural health product

NHPR

Natural Health Products Regulations

NHPID

Natural Health Products Ingredients Database

NNHPD

Natural and Non-prescription Health Products Directorate

NOC

notice of compliance

NOD

notice of deficiency

NOD-W

NOD-withdrawal

NON

notice of non-compliance

NON-W

NON-withdrawal

NPD

non-prescription drug

NPN

natural product number

PBRER

periodic benefit-risk evaluation report

PDD

Pharmaceutical Drugs Directorate

PDL

Prescription Drug List

PDSC

Prescription Drug Status Committee

PLA

product licence application

PSUR

periodic safety update report

Rx

prescription

RMP

risk management plan

SL

site licence

SDN

screening deficiency notice

SNDS

supplement to a new drug submission

TBT

Technical Barriers to Trade

US FDA

the United States Food and Drug Administration

Definitions

Note: The following definitions are for the purposes of this guidance document and the use of these terms may differ in other Health Canada documents.

Abuse:

The use of a product for purposes other than for which it was prescribed (for example, using it for its reinforcing properties).

Addiction (substance use disorder):

The compulsive and continuous use of a substance despite negative impacts to a person, their family, friends and others, typically involving cravings and impaired control over use.

Applicant:

The company that is the applicant or sponsor that is initiating the request for an Rx to NPD or Rx to NHP switch.

Canadian Drug Facts Table:

A table on the outer label of NPDs that is required to display specific information, as per subsection C.01.004.02 (1) of the FDR. The purpose of the table is to display the information in a standardized, easy-to-read format in order to enhance the safe and effective use of NPDs.

Conditions:

This refers to diseases, conditions, disorders, abnormal physical states or their symptoms (for the purposes of simplifying the text of this guidance document).

Conditions of use:

These include elements such as the:

• use, indication or purpose of a health product
• dosage form
• route of administration
• dose (including sub-population, amount, dosage unit, frequency and directions for use)
• duration of use, if any, and
• risk information, including precautions, warnings, contraindications or known adverse reactions associated with the use of the product or its medicinal ingredients

Dependence:

Difficulty discontinuing drug use due to unpleasant physical and/or psychological withdrawal effects.

Drug-device combination product:

A therapeutic product that combines a drug component and a medical device component (which by themselves would be classified as a drug or a device), such that the distinctive nature of the drug component and device component is integrated in a singular product.

Intercepted medication error (near miss):

An event that could have resulted in unwanted consequences, but did not because either by chance or through timely intervention the event did not reach the patient.

Market experience:

Knowledge gained about an authorized product once it is being sold.

Medicinal ingredient:

The substance in the product that contributes to the product’s therapeutic effect (synonym: active ingredient).

Non-prescription status:

The default status of ingredients or products that are not prescription drugs, prescription drug products or products with prescription status. For example, NPDs and NHPs both have non-prescription status.

Practitioner:

An individual who is entitled to treat patients with prescription drugs according to provincial or territorial laws and is practising their profession in that province or territory. Two common examples are doctors and dentists.

Product Facts Table:

A table on the outer label of some NHPs that displays important information about the product in a standardized format so that the information is clear, consistent and legible for consumers.

Psychoactive effects:

Effects of a substance or mixture of substances on the central nervous system that result in temporary changes in cognition, perception, mood and consciousness, which can lead to temporary changes in behaviour. Examples of these include dizziness, calmness, stimulation, anxiety, irritability, cognitive impairment, hallucinations, drowsiness and euphoria.

Serious adverse reaction:

A noxious and unintended response to a drug that occurs at any dose and that:

• requires in-patient hospitalization or prolongation of existing hospitalization
• causes congenital malformation
• results in persistent or significant disability or incapacity
• is life-threatening or
• results in death

Submission filing date:

The date that the submission is deemed administratively complete by Health Canada (that is, once all elements and forms required for processing are completed and submitted to Health Canada).

Switch:

A change of status from prescription status to non-prescription status.

Switch submission:

For Rx to NPD switches, this term refers to the NDS or SNDS in which a switch is requested. For Rx to NHP switches, this term refers to the NDS and the PLA, or the SNDS and the PLA, in which the switch is requested.

Tolerance:

The need to take progressively higher doses of a drug substance in order to achieve the same desired effect.

Dependence, addiction, misuse and abuse terminology

The Government of Canada is proposing the use of new terminology related to substance use to minimize stigma and discrimination. For more information on the Government of Canada’s guide to terminology, consult:

• Stigma: Why Words Matter

Also, Health Canada notes that the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM‑5) has moved away from using the term “addiction”. The DSM‑5 has also replaced the previous diagnostic categories of “substance dependence” and “substance abuse” with “substance use disorders”. These changes suggest that use of these terms is evolving.

Health Canada has opted to use the terms “abuse”, “dependence” and “addiction” in this guidance document. One of the reasons for this is because post-marketing adverse reactions collected by International Conference on Harmonisation (ICH) members are categorized based on Medical Dictionary for Regulatory Activities (MedDRA) terminology, which continues to use these terms. As adverse reactions data is central to switches, we want to ensure that companies are clear on the search terms to use when collecting data for submissions.