Switching a medicinal ingredient from prescription to non-prescription status draft guidance document: Overview

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Organization: Health Canada

Date published: April 2022

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Document change log

Date Change Location Nature of and/or Reason for Change

April 21, 2022

The document was revised and re-organized.


The guidance document “Data requirements for switching medicinal ingredients from prescription to non-prescription status” effective May 7, 2014, was revised to

  • reflect changes to the process for switches from prescription drug to natural health product that will ensure regulatory support;
  • clarify evidence requirements relative to the Prescription Drug List principles and factors; and
  • provide guidance to industry on completing a new template that is being requested as part of submissions for switches.

This guidance document is being distributed for comment purposes only.

Date : 2022/04/21

1. Introduction

Companies can file submissions/applications with Health Canada to request a “switch” of a medicinal ingredient from prescription to non-prescription status for certain conditions of use. Following a successful switch process, the proposed product has non-prescription status. That is, Health Canada authorizes the proposed product as either a Natural Health Product (NHP) or a Non-Prescription Drug (NPD). These kind of switches are referred to as an “Rx to NHP switch” and “Rx to NPD switch”, respectively.

2. Purpose

This document includes guidance for companies (applicants) who wish to put forward submissions/applications to request a switch of an ingredient from prescription to non-prescription status. In this document, the term “applicant(s)” refers to an applicant or a sponsor; and this applicant is the company who is initiating the request for the switch. A glossary of all key terms is provided in Appendix A.

This document provides applicants with the following information:

3. Scope and application

This guidance document applies to submissions/applications filed with Health Canada requesting the switch of a medicinal ingredient for human use from prescription to non-prescription status (NHP or NPD).

This guidance document does not apply to the following:

For information and guidance regarding veterinary drug switch submissions, contact the Veterinary Drugs Directorate.

4. Background

In this section, Health Canada provides information on the way the federal prescription status is determined and on requests to change the prescription status of a medicinal ingredient. Additionally, the role of the provinces and territories in granting prescription status is discussed.

4.1 Regulatory framework

Prescription drugs, that is, drugs with federal prescription status, are regulated under the Food and Drug Regulations (FDR). They are not subject to the Natural Health Products Regulations (NHPR) as they are excluded by virtue of Section 2(2) of the NHPRFootnote 2.

Products with non-prescription status are regulated under the NHPR if the products meet the definition of an NHP in the NHPR and otherwise, are regulated under the FDR as NPDs.

4.2 Prescription status

Products with federal prescription status have their medicinal ingredient(s) listed in the PDL. The PDL is a web-based administrative list established by the Minister under the authority of the Food and Drugs Act. Products with a medicinal ingredient on the PDL are only obtained by the public through a prescription.

Note the above differs for ingredients that are controlled substances under the Controlled Drugs and Substances Act (i.e., when they are listed in the schedules to the Act and its regulations). When these drugs are restricted to prescription-only status under the Controlled Drugs and Substances Act, the ingredients are not listed on the PDL.

Health Canada determines if a medicinal ingredient under specified conditions of use requires the oversight of a practitioner for its safe and effective use. To make this determination, Health Canada relies on established overarching principles and associated factors.

The overarching principles governing prescription status are stated in section C.01.040.3 of the FDR and are further described, along with the factors, in the guidance document entitled "Determining Prescription Status for Human and Veterinary Drugs".

When one or more of the PDL principles or associated factors applies to a medicinal ingredient under the specified conditions of use, Health Canada generally considers the medicinal ingredient to require practitioner involvement. When practitioner involvement is necessary, Health Canada gives the medicinal ingredient prescription status and adds it to the federal Prescription Drug List (with the exception described above for controlled substances).

4.3 Removal of medicinal ingredients from the PDL

Companies may request the removal of a medicinal ingredient from the PDL in different contexts and the following are two examples:

The majority of switches removing a medicinal ingredient from the PDL occur as a result of applicant-initiated switch submissions to Health Canada. In exceptional circumstances, Health Canada may pursue a switch based on an assessment of available evidence to support the use of a medicinal ingredient in an NHP or an NPD. In such cases, an assessment of the application of the PDL principles and factors remains integral to the decision-making process.

Note that in Canada, a successful switch process, which includes the removal of a medicinal ingredient (or removal of a medicinal ingredient for specific conditions of use) from the PDL, may result in other companies’ similar products no longer having prescription status. (More information in section 19.7.)

4.4 Requests for switches

For Rx to NHP switches:

For Rx to NPD switches:

Section 9 of this guidance document outlines when an NDS vs. SNDS is required. Note that, an applicant who wishes to switch their existing, authorized, “Division 1” prescription drug to non-prescription status, must apply under Division 8 (NDS). (The change to ‘sale in the non-prescription setting’ is considered to be a change in the conditions of use as a drug, thereby meeting the definition of a “New Drug”.)

4.5 Provincial and territorial decisions

In addition to federal decisions about a medicinal ingredient's prescription status, provinces and territories can further regulate the conditions and place of sale of products. For example, products with medicinal ingredients that have non-prescription status federally may be required by provincial or territorial law to be sold behind-the-counter in pharmacies or by prescription. Although provinces and territories can further restrict the sale of products, they cannot lessen the imposed federal restrictions. Therefore, products that require a prescription at the federal level will also require a prescription at the provincial and territorial level.

In summary, medicinal ingredients are given prescription status when practitioner involvement is deemed the best method to protect the health and safety of Canadians. If it can be demonstrated that practitioner oversight is not necessary, then the medicinal ingredient, usually under specified conditions of use, can be removed from the PDL allowing for the possibility of its sale in an NHP or NPD.

5. Policy statements

The following policies and regulatory requirements relate to prescription and non-prescription status:

A note about guidance documents in general

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents.

Footnote 1

For more information on exceptions, refer to the guidance document “Determining Prescription Status for Human and Veterinary Drugs”. Note that the process for the assessment of switches is not the same as the process for assessing the need for exceptions to prescription status.

Return to footnote 1 referrer

Footnote 2

NHPR section 2(2): “ For the purposes of these Regulations, a substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the Food and Drug Regulations, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations.”

Return to footnote 2 referrer

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