The Prescription Drug List: Processes to amend

On this page

• Purpose
• Types of PDL amendments
• Routine additions
• Special additions
• Switches (removals)
• International obligations

Purpose

This document aims to provide detailed information for industry and other interested parties on our administrative processes for amendments to the Prescription Drug List (PDL). For a less detailed version of these processes, consult the second last section of the Prescription Drug List: Overview.

Note: The term “drug” used in this text has the meaning given in the Food and Drugs Act.

Types of PDL amendments

The three main types of amendments are:

• routine additions
• special additions
• switches (removals)

The triggers and process for each of these types of PDL amendments is described in the following sections.

Routine additions

Note: This section focuses on routine additions initiated in response to a company’s submission for market authorization.

Routine additions are amendments to the PDL that result in the capture of a medicinal ingredient or a medicinal ingredient for specific conditions of use that was not already captured by a listing on the PDL.

Context: new prescription drug

The most common situation leading to a routine addition is a drug submission for a product containing a medicinal ingredient that is new to the Canadian market.

Another situation is where the health product contains a medicinal ingredient that is not new but is being proposed for 1 or more new conditions of use (e.g. new route of administration). Thus, the conditions of use of the new health product differ from those of other health products with that medicinal ingredient that are already authorized for the Canadian market.

Steps preceding the PDL amendment process for a routine addition

Our initial evaluation of whether a drug should have prescription status occurs during the assessment of a drug submission for market authorization.

Our assessment officers evaluate whether the health product should be available by prescription only. This evaluation involves consideration of three principles and their associated factors. These principles and factors are used to determine whether involvement of a practitioner (prescriber) is necessary for the safe and appropriate use of the product.

For more information on the PDL principles and factors, consult the guidance document:

• Determining Prescription Status for Human and Veterinary Drugs

The assessment officers present their evaluation of the applicability of the PDL principles and factors, and their recommendation regarding a PDL amendment to an internal committee. This committee of scientific and medical experts is called the Prescription Drug Status Committee (PDSC).

The PDSC has core members from Health Canada’s:

• Veterinary Drugs Directorate
• Pharmaceutical Drugs Directorate
• Marketed Health Products Directorate
• Biologic and Radiopharmaceutical Drugs Directorate
• Natural and Non-prescription Health Products Directorate

Members from other directorates participate as needed.

The PDSC’s role is to make recommendations regarding all proposed PDL amendments to the Director General (DG) of the Pharmaceutical Drugs Directorate in the Health Products and Food Branch.

On behalf of the Minister, the DG makes decisions regarding the PDL. This includes final decisions on whether to propose amendments to the PDL and whether to amend the PDL.

In summary, we propose an addition to the PDL when:

• we have assessed a company’s application or submission and determined that the company’s proposed product meets the requirements of the Food and Drug Regulations for market authorization
• we have determined that the involvement of a practitioner is required for the safe and appropriate use of the product (that is, the product should be a prescription drug) and
• the medicinal ingredient as presented in the proposed product is not currently captured by any of the PDL listings

Mechanism

For the routine additions, we amend the PDL by:

• adding a listing for the medicinal ingredient or the medicinal ingredient for specific conditions of use, if the medicinal ingredient is not already on the PDL or
• modifying an existing listing such that it captures the medicinal ingredient for specific conditions of use related to the new product

PDL amendment process for routine additions

1. We add a new medicinal ingredient listing or modify the existing listing on the PDL. This amendment comes into immediate effect.
2. We also web-post a “notice of amendment”.

The notice of amendment informs the public and other stakeholders of:

• the addition to the PDL
• the rationale for the addition
• the effective date for the amendment

For current and past notices, visit Notices of changes to the Prescription Drug List.

Impact of routine additions on other health products

This kind of amendment has no impact on the market authorization of other health products.

In most cases, there are no other market-authorized health products with the same medicinal ingredient as the new prescription drug and therefore, there is no impact.

In other cases, the medicinal ingredient is in other market-authorized health products, but the new prescription drug would be authorized for different conditions of use (for example, a different indication or route of administration). Thus, the new or revised PDL listing for the medicinal ingredient does not affect the status (prescription or non-prescription) of the products that were already authorized.

Special additions

Context: changing from non-prescription to prescription status

This type of addition is typically triggered by new information about a health product with non-prescription status (a natural health product or non-prescription drug) on the market. This new information could arise, for example, from the analysis of post-market safety signals.

The information can lead us to re-assess whether the involvement of a practitioner would be needed to help mitigate the newly identified risks. If we determine that changing the non-prescription status to prescription status is the best way to mitigate the risks, a PDL amendment will be pursued.

Thus, special additions are PDL amendments that result in products with non-prescription status becoming prescription drugs.

Steps preceding the PDL amendment process for a special addition

Similar to the situation for a routine addition, assessment officers make recommendations to the PDSC, which in turn makes recommendations to the DG of the Pharmaceutical Drugs Directorate. Again, these evaluations consider the applicability of the PDL principles and factors.

If the decision is that practitioner involvement is now recommended, we initiate the PDL amendment process to add the medicinal ingredient or the medicinal ingredient for certain conditions of use to the PDL.

Mechanism

Depending on what already appears on the PDL, the proposed amendment is achieved by:

• adding a new PDL listing for the medicinal ingredient or the medicinal ingredient for specific conditions of use to the PDL or
• modifying the qualifier of the existing PDL listing so that it captures the medicinal ingredient for specific conditions of use

PDL amendment process for special additions:

1. We notify companies whose non-prescription drugs or natural health products may be affected by the proposed change about the upcoming consultation on the proposed PDL amendment. We also inform them of our proposed transition plans for their affected health products.

2. We launch a public consultation on the proposed addition to the PDL by web-posting a “notice of consultation.”

   The notice of consultation outlines the following:
   • the proposed modification of the PDL for the addition
   • the rationale for the addition
   • the instructions for participating in the consultation
3. The consultation period is 75 calendar days. During this time, the public, the impacted companies and all other interested stakeholders can submit comments on the proposed addition.
4. We analyze the comments received during the consultation and decide whether to:
   • stop pursuing the proposal to amend the PDL
   • modify the proposal before proceeding or
   • proceed as proposed with the PDL amendment
5. We contact companies whose drugs or natural health products would be affected by the proposed change to inform them of the decision and if applicable, the next steps.
6. We also inform all stakeholders of the decision by web-posting a “notice of intent.” In the case where the amendment is going to proceed, the notice includes:
   • a summary of comments received and our response
   • our decision to add the medicinal ingredient or medicinal ingredient for specific conditions
   • a statement that the addition to the PDL would be made after a transition period and the length of that transition period

   • an explanation of the steps impacted companies need to take to comply with the regulatory requirements for prescription drugs

   The transition period delays implementation, typically a minimum of 6 months from the date of the web-posting of the notice of intent. This transition period provides impacted companies with time to comply with the regulatory requirements for prescription drugs. (For additional information on the transition period, consult the section International obligations).

7. After this transition period of at least 6 months, we make the addition to the PDL. At the same time, we web-post a “notice of amendment.”

   The notice of amendment includes:
   • a statement that the PDL has been amended so that it captures the medicinal ingredient or the medicinal ingredient for specific conditions of use
   • the rationale for the addition
   • the effective date for the amendment

PDL amendment process for urgent situations

Some health and safety issues that arise for human or veterinary drugs require immediate action for the protection of consumers, users or animals. In these rare situations, we shorten or forgo the consultation and/or transition period. We also web-post a “notice of amendment” informing the public and other stakeholders of the addition and the rationale for the expedited process.

Impact of special additions on other health products

In the case of special additions, there are typically authorized products, non-prescription drugs or natural health products, that are affected. After the PDL is amended, companies may no longer sell their affected non-prescription drugs or natural health products.

Companies with affected products that wish to continue to sell them after the PDL is amended, need to:

• ensure their products comply with the regulatory requirements for prescription drugs
• file an application or submission for their products as prescription drugs
• obtain the new or updated market authorization, as applicable

Switches (removals)

Context: changing from prescription to non-prescription status

“Switch” refers to the change in the status of a health product from prescription status to non-prescription status. Typically, a company files a submission for market authorization under the Food and Drug Regulations and includes a request to have the PDL amended. The PDL amendment would mean that at federal level, their product could be sold:

• as a non-prescription drug or as a natural health product if the drug product is for human use or
• as a non-prescription drug for companion or food-producing animals if the drug product is for veterinary use.

Note: switches initiated by a company may impact the status of other companies’ prescription drugs.

Steps preceding the PDL amendment process for a switch

For human use products, refer to the guidance document Switching from prescription to non-prescription status for more detailed information on switches, including on:

• how a company can request a switch
• how the switch submission process differs for prescription to non-prescription drug switches versus prescription to natural health product switches

For information on how to request a switch related to a product for veterinary use, contact the Veterinary Drugs Directorate:

• Email: vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca

For both human and veterinary switches, our assessment officers make recommendations to the PDSC, which in turn makes recommendations to the DG of the Pharmaceutical Drugs Directorate. These evaluations consider the applicability of the PDL principles and factors.

If the decision is that practitioner involvement is unnecessary, we initiate the PDL amendment process to remove the medicinal ingredient or the medicinal ingredient for certain conditions of use from the PDL.

Mechanism

Depending on what already appears on the PDL, the proposed amendment for the switch is achieved by:

• removing the medicinal ingredient listing from the PDL
• adding a qualifier to the existing PDL listing to exclude the medicinal ingredient for specific conditions of use or
• modifying the qualifier of the existing PDL listing to exclude the medicinal ingredient for specific conditions of use

PDL amendment process for a switch initiated by a company

1. After informing the initiating company of our intent to launch the PDL amendment process, we also inform other impacted companies of the upcoming consultation on the proposed PDL amendment and the proposed transition plans for their affected products.

2. We launch a public consultation on the proposed removal of a medicinal ingredient or medicinal ingredient for specific conditions of use from the PDL by web-posting a “notice of consultation”.

   The notice of consultation outlines the following:
   • the proposed modification to the PDL for the removal
   • the rationale for the removal
   • the instructions for participating in the consultation
3. The consultation period is 75 calendar days. During this time the public, impacted companies and all other stakeholders can submit comments on the proposed removal from the PDL.
4. We analyze the comments received during the consultation and decide whether to:
   • stop pursuing the proposal to amend the PDL
   • modify the proposal before proceeding or
   • proceed as proposed with the PDL amendment

5. We inform the company that initiated the switch of our decision.

   Note: If it is a human prescription drug to natural health product switch, a notice of potential reclassification is sent to the company at this time. For more details on this notice, consult the guidance document Switching from prescription to non-prescription status.

6. We also inform impacted companies and all stakeholders of the decision by web-posting a “notice of intent.” Where the amendment is proceeding, the notice of intent includes:
   • a summary of comments received and our response
   • our decision to remove the medicinal ingredient or the medicinal ingredient for specific conditions of use
   • a statement that the removal from the PDL will be made 6 months after the date of the web-posting of the notice of intent
   • the steps impacted companies need to take to comply with the regulatory requirements for non-prescription drugs or natural health products, as applicable
7. The 6-month transition period provides a delayed implementation. This allows time for the other impacted companies to file applications or submissions and make changes to their products.

8. After the transition period, we amend the PDL to remove the medicinal ingredient or the medicinal ingredient under specified conditions of use and then, we web-post a “notice of amendment.”

   The notice of amendment includes:
   • a statement that the medicinal ingredient or medicinal ingredient for certain conditions of use has been removed from the PDL
   • the rationale for the removal
   • the effective date for the amendment

   Note: If it is a human prescription drug to natural health product switch, we issue a notice of reclassification to the initiating company at this time.

Impact of a switch on other health products

As mentioned, a switch can have an impact on other similar prescription drugs. During the process to amend the PDL, companies should verify if the amendment affects their products. We will also contact impacted companies as described in the previous section.

Where the switch results in the medicinal ingredient being entirely removed from the PDL, the impacted companies will no longer be able to sell their products as prescription drugs. However, they can file an application or submission to obtain their market authorization as a non-prescription status product (non-prescription drug or natural health product, as applicable).

Where the switch results in the medicinal ingredient being removed from the PDL for certain conditions of use only, the impacted companies’ options depend on whether their prescription drug product:

• matches these conditions of use 
• has been authorized for other conditions of use as well

We will outline the options for impacted companies.

International obligations

The process to amend the PDL aligns with Canada’s international obligations, under the World Trade Organization’s Agreement on Technical Barriers to Trade and various free trade agreements. Specifically, the process to amend the PDL for special additions and switches includes:

• a notification of changes to other countries
• a consultation during which stakeholders, including other countries, can provide input
• a transition period that provides affected companies with a reasonable interval to come into compliance before the entry into force of the changes to the PDL

Under these agreements, a reasonable interval has been understood to be a minimum of 6 months. However, Canada maintains the ability to waive the consultation period and the reasonable interval (transition period) when urgent safety, health, environmental protection or national security risks or threats arise.