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

Document change log

Date	Change	Location	Nature of and/or reason for change
August 14, 2024	The document was revised and re-organized.	throughout	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 product to natural health product clarify evidence requirements related to the Prescription Drug List principles and factors provide guidance to companies on completing a new template that is being requested as part of submissions for switches The new title for the guidance document is Switching from Prescription to Non-Prescription Status.

On this page 

• Introduction
• Scope and application
• Background
• Policy statements
• Note about guidance documents in general

Introduction

The purpose of this document is to provide guidance for companies that wish to:

• request a “switch” of a medicinal ingredient for specific conditions of use from prescription (Rx) to non-prescription status and
• file submissions/applications for a market authorization for their proposed product

Following a successful switch process, the proposed product will have non-prescription status. That is, Health Canada authorizes the proposed product as either a non-prescription drug (NPD) or a natural health product (NHP). These kinds of switches are referred to as an “Rx to NPD switch” and “Rx to NHP switch”, respectively.

In this document, the term “applicant” is the company that is the applicant or sponsor that is initiating the request for the switch.

Definitions of other key terms are found in the Glossary.

This document provides applicants with the following information:

• advice on determining whether the proposed non-prescription status product would be an NPD or NHP
• an overview of the federal processes for Rx to NPD and Rx to NHP switches
• details on each step of the process
• direction on evidence to be included in submissions and applications
• guidance on related topics such as applicable requirements in terms of good manufacturing practices (GMP), site licences (SLs) and drug establishment licences (DELs) for those carrying out the manufacturing and other activities relative to the proposed product

Scope and application

This guidance document applies to applicants requesting:

• a market authorization for their proposed product and
• the switch of a medicinal ingredient for human use from prescription to non-prescription status such that the proposed product could be sold as an NPD or an NHP

This guidance document does not apply to:

• switch submissions for biologic or radiopharmaceutical products
• switch submissions for veterinary drugs
• requests for exceptions to the Prescription Drug List (PDL)
  • for example, naloxone when indicated for emergency use for opioid overdose and the flu vaccine

For information and guidance on veterinary drug switch submissions, contact the Veterinary Drugs Directorate:

Telephone: 613-321-4239
Email: athc.vdd.vetdrugs-medsvet.dmv.sc@canada.ca

For information on exceptions, consult:

• Determining prescription status for human and veterinary drugs

Note that the process for assessing switches is not the same as the process for assessing the need for exceptions to prescription status.

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. The role of the provinces and territories in granting prescription status is also discussed.

Regulatory framework

Prescription drug products, that is, products 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 subsection 2(2) of the NHPR.

Subsection 2(2) states: “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.”

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

Prescription status

Products with federal prescription status have at least 1 medicinal ingredient listed in the PDL and are only obtained by the public through a prescription. The PDL is a web-based administrative list established by the Minister under the authority of the Food and Drugs Act.

• Prescription Drug List (PDL)

The situation is somewhat different for ingredients that are controlled substances under the Controlled Drugs and Substances Act (CDSA) (that is, ingredients listed in the schedules to the Act and its regulations). When these ingredients are restricted to prescription-only status under the CDSA, they are not listed on the PDL. However, drugs containing controlled substances still must meet the requirements of the FDR to be sold lawfully for therapeutic purposes.

Health Canada determines if a product or a medicinal ingredient under specific conditions of use requires the oversight of a practitioner for its safe and appropriate use. To make this determination, we rely on established principles and associated factors. The principles governing prescription status are broad and include the concepts detailed in the factors.

The overarching principles are stated in section C.01.040.3 of the FDR. They are further described, along with the factors, in Determining prescription status for human and veterinary drugs.

When 1 or more of the PDL principles and associated factors applies to a product (that is, to a medicinal ingredient under specific conditions of use), Health Canada generally considers the medicinal ingredient to require practitioner involvement. When practitioner involvement is necessary, we give the medicinal ingredient prescription status and add it to PDL, with the exception noted for controlled substances.

Removal of medicinal ingredients from the PDL

Companies may request the removal of a medicinal ingredient from the PDL in different contexts. The following are 2 examples:

• Over time, with extended use of a company’s marketed prescription drug product, additional information (such as post-market safety data) becomes known, reducing uncertainties about the product. The company may then wish to make the case to Health Canada that this additional information supports the safe and effective use of its product without practitioner oversight. To do so, the company files a submission for a market authorization for its proposed NPD or NHP and requests the switch. Most switches occur in this context.
• A company wishes to propose a new NPD or NHP for the Canadian market, however, the medicinal ingredient in the proposed product is on the PDL. The company also does not have an authorized prescription drug product related to the proposed product. The company has data supporting the use of the proposed product without practitioner oversight. The company files a submission for a market authorization for its proposed NPD or NHP and requests the switch.

The majority of switches removing a medicinal ingredient (or a medicinal ingredient for specific conditions of use) 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 that supports the use of a medicinal ingredient in an NPD or an NHP. In both cases, an assessment of the applicability of the PDL principles and factors remains integral to the decision-making process.

Note: In Canada, a successful switch process, which includes the removal of a medicinal ingredient (or a medicinal ingredient for certain conditions of use) from the PDL, may result in other companies’ similar products no longer having prescription status. For more information, refer to the section The impact of a switch on other prescription drug products.

Requests for switches

For Rx to NPD switches:

• The applicant files the request as part of a new drug submission (NDS) or a supplement to a new drug submission (SNDS).

For Rx to NHP switches:

• The applicant files the request as part of an NDS or an SNDS and, if that submission is successful, the applicant then provides a product licence application (PLA). The submissions begin under the FDR in light of subsection 2(2) of the NHPR.

The section Assembling NDS or SNDS (all switches) outlines when an NDS versus SNDS is required. Note that an applicant who wishes to switch their existing prescription drug product that was authorized under Division 1 of Part C of the FDR to non-prescription status must apply in accordance with Division 8 of Part C of the FDR (NDS). (The change to “sale in the non-prescription setting” is considered to be a change in the conditions of use of a drug. In most instances, this condition of use will not have established safety and effectiveness. Therefore, the proposed product would meet the definition of a “new drug”.)

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. They do so through the regulation of health care professionals and health care establishments.

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 federally imposed 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 of protecting and promoting 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 NPD or NHP.

Policy statements

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

• Health Canada verifies the applicability of the PDL principles and factors to the product as part of the assessment of all applications and submissions under the FDR and NHPR, where the medicinal ingredient(s) under the specified conditions of use have not previously been authorized.
• Health Canada typically considers a medicinal ingredient, under specified conditions of use, to warrant prescription status when practitioner involvement is required to ensure safe and appropriate use of the product. This is determined based on the applicability of 1, or more, of the PDL principles and associated factors.
• If none of the PDL principles and factors apply to a product, it would typically have non-prescription status either as an NPD or an NHP.
• In general, Health Canada considers requests to change the prescription status of a medicinal ingredient on the PDL through the company-initiated switch process described in this document. As products containing medicinal ingredients listed on the PDL are regulated under the FDR, requests for switches pertaining to these ingredients also fall under the FDR. Therefore, it is under the FDR that we process requests for Rx to NPD switches and initiate the process for requests for Rx to NHP switches.
• The PDL is an ingredient-based list. In contrast, Health Canada’s assessment of a switch to determine whether the PDL should be amended is a product-based decision. This is explained by the fact that it is very difficult to assess all the PDL principles and factors without knowing a product’s conditions of use.
• When a Health Canada assessment concludes that an applicant has demonstrated that none of the PDL principles and factors apply and the proposed product has a positive benefit-risk profile as a non-prescription status product, we initiate the process to amend the PDL.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.