Switching a medicinal ingredient from prescription to non-prescription status draft guidance document: Overview

Organization: Health Canada

Date published: April 2022

On this page

• Document change log
• 1. Introduction
• 2. Purpose
• 3. Scope and application
• 4. Background
• 5. Policy statements
• A note about guidance documents in general

Document change log

This guidance document is being distributed for comment purposes only.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:

• advice on determining whether the proposed non-prescription status product would be an NHP or NPD
• an overview of processes for Rx to NHP and Rx to NPD switches
• details on each step of the process
• direction on evidence to be included in submissions/applications
• guidance on related topics such as
  • applicable requirements in terms of Good Manufacturing Practices (GMP) as well as Site Licences (SLs) and Drug Establishment Licences (DELs) for those carrying out the manufacturing and other activities related to the proposed product; and
  • patent and data protection

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:

• switch submissions for biologic or radiopharmaceutical products
• switch submissions for veterinary drugs
• requests for exceptions to the Prescription Drug List (PDL)^{Footnote 1}  (e.g. naloxone and the flu vaccine)

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 NHPR^{Footnote 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:

• Over time, with extended use of the company’s marketed prescription drug, additional information becomes known about the drug product. The company may then file a switch submission to Health Canada to make the case that this additional information supports the safe and effective use of the product without practitioner oversight. Most switches occur in this context.
• The company wishes to propose a new NHP or NPD product for the Canadian market, however, the medicinal ingredient in the proposed product is on the PDL. Additionally, the company does not have an authorized prescription drug related to the proposed product. The company has data supporting the use of the proposed product without practitioner oversight and files a switch submission to request the removal of a medicinal ingredient in order to market the proposed product as an NHP or an NPD.

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:

• The applicant files the request in the form of a New Drug Submission (NDS) or a Supplement to a New Drug Submission (SNDS) and, if that submission is successful, the applicant then files a Product Licence Application (PLA). The submissions begin under the FDR in light of section 2(2) of the NHPR.

For Rx to NPD switches:

• The applicant files the request in the form of an NDS or SNDS.

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:

• Health Canada typically considers a medicinal ingredient, under specified conditions of use, to warrant prescription status when practitioner involvement is appropriate. This is determined based on the applicability of one, or more, of the PDL principles or associated factors.
• Health Canada generally 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 Health Canada processes requests for Rx to NPD switches and initiates 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 submission to determine whether the PDL should be amended is a product-based decision as it is very difficult to assess all the PDL principles and factors without knowledge of 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 to a product and the proposed product has a positive benefit-risk profile as an NHP or NPD, Health Canada initiates the process to amend the PDL.

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.

• Next