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Guidance on switching from prescription to non-prescription status: Switch process

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Determining which switch process applies

The applicant needs to assess whether their proposed product ought to be classified as a non-prescription drug (NPD) or natural health product (NHP), if the switch was successful. This determination will help the applicant identify which process in this guidance document applies to their situation:

The applicant should verify whether, following a successful switch, the proposed product would meet the definition of an NHP as set out in section 1(1) of the Natural Health Products Regulations (NHPR). If so, a successful switch results in the product being classified as an NHP. Otherwise, it is classified as an NPD under the Food and Drug Regulations (FDR).

When considering whether the proposed product’s ingredients are acceptable in an NHP, tools such as the Natural Health Products Ingredients Database (NHPID) can also be consulted for information on current ingredient classifications and restrictions.

Applicants can discuss their proposed product’s classification with Health Canada prior to filing (for example, in a pre-submission meeting) to hear our preliminary thoughts on a likely classification (NPD or NHP).

Regardless of whether this issue is dealt with in a pre-submission meeting, Health Canada will make the final decision on the classification once the submission is in review and we have access to the full information. If, at this time, we disagree with the classification proposed by the applicant, we will discuss this with the applicant as well as how the switch process will then change.

The remaining sections of this document are based on the assumption that there are no issues regarding classification of the product after the PDL amendment.

Understanding the switch processes

This section provides an overview of the federal switch processes for Rx to NPD and Rx to NHP switches. Refer to the next 2 subsections for a stepwise description of the overall processes for successful switches. Flowcharts 1 and 2 visually depict this information. We discuss unsuccessful switches in the third subsection.

Following the overview of these processes, we provide detailed guidance on the steps of the processes.

Process 1: A successful Rx to NPD switch

The following is the main process for an Rx to NPD switch that leads to Health Canada issuing or updating a market authorization:

  1. Optional (but recommended): The applicant assembles the pre-submission meeting data package for Health Canada and requests a pre-submission meeting.
  2. Optional (but recommended): The applicant meets with Health Canada for a pre-submission meeting to present and discuss the data package for the proposed switch. This meeting may lead the applicant to conduct further studies and may identify whether there are any classification issues that could arise during review.
  3. The applicant assembles the final version of the new drug submission (NDS) or supplement to a new drug submission (SNDS). This submission includes the necessary data on safety, efficacy/effectiveness and quality, product labelling, and the “PDL principles and factors assessment”.
  4. The applicant files the NDS or SNDS with Health Canada in the appropriate format and pays the applicable fees.
  5. Health Canada screens the submission for completeness. If no screening deficiencies are identified, the submission proceeds into review.
  6. Health Canada assesses the submission including the information submitted in the PDL principles and factors assessment. If our assessment is positive, the process continues.
  7. Health Canada posts a public notice of consultation outlining our proposal to remove the medicinal ingredient or the medicinal ingredient for certain conditions of use from the PDL. We also put the NDS or SNDS on “switch hold”.
  8. After a 75-day PDL consultation period, Health Canada reviews the comments received from the public and other stakeholders.
  9. After analyzing the comments, if Health Canada decides to proceed, we post a notice of intent announcing that the amendment to the PDL will occur in 6 months’ time.
  10. After the 6-month transition period, Health Canada amends the PDL and posts a notice of amendment.
  11. Health Canada issues a drug identification number (DIN), if applicable, and a notice of compliance (NOC) for the NPD.
  12. If in addition to the NOC, the appropriate DEL(s) have been issued to those conducting licensable activities related to the product (for example, fabricate), the product can be sold in Canada in accordance with the FDR.

Flowchart 1: A successful Rx to NPD switch

Flowchart 1

Text description

A shorter version of  steps for the process 1 are illustrated in a flowchart:

  1. The applicant participates in a pre-submission meeting with Health Canada.
  2. The applicant submits an NDS or SNDS for assessment.
  3. Following a successful NDS or SNDS, Health Canada proposes an amendment to the PDL.
  4. Health Canda posts a Notice of Consultation related to the proposed amendment to the PDL.
  5. After analyzing the comments, if Health Canada decides to proceed, Health Canada posts a Notice of Intent announcing that the PDL will be amended in 6 months’ time.
  6. After the 6 months, Health Canada amends the PDL and posts a Notice of Amendment.
  7. Health Canada issues a new DIN (if applicable) and the NOC.
  8. With the DEL(s) in place and the NOC obtained, the applicant can market the NPD.

Additionally, the image shows that all steps of this process fall under the FDR and steps 3, 4, 5 and 6 are part of the PDL amendment process.

Process 2: A successful Rx to NHP switch

A successful Rx to NHP switch moves the proposed product from the FDR to the NHPR. An Rx to NHP switch must begin under the FDR in light of subsection 2(2) of the NHPR. The proposed product can only move to the NHPR if the NDS or SNDS results in removal from the PDL of the medicinal ingredient or medicinal ingredient for the relevant conditions of use.

However, to facilitate market access, Health Canada is willing to contemplate whether the PLA would meet the NHPR requirements prior to the PDL amendment, provided the applicant follows the process set out in this guidance document. Note: Decisions under the NHPR can only be made after the PDL is amended and the proposed product becomes subject to these regulations.

The following is the main process for an Rx to NHP switch that leads to a market authorization being issued. The first 8 steps of this process are the same as those for an Rx to NPD switch.

  1. Optional (but recommended): The applicant assembles the pre-submission meeting data package for Health Canada and requests a pre-submission meeting.
  2. Optional (but recommended): The applicant meets with Health Canada for a pre-submission meeting to present and discuss the data package for the proposed switch. This meeting may lead the applicant to conduct further studies and may identify whether there are any classification issues that could arise during review.
  3. The applicant assembles the final version of the NDS or SNDS. This submission includes the necessary data on safety, efficacy/effectiveness and quality, product labelling, and the “PDL principles and factors assessment”.
  4. The applicant files the NDS or SNDS with Health Canada in the appropriate format and pays the applicable fees.
  5. Health Canada screens the submission for completeness. If no screening deficiencies are identified, the submission proceeds into review.
  6. Health Canada assesses the submission, including the information submitted in the PDL principles and factors assessment. If our assessment is positive, the process continues.
  7. Health Canada posts a public notice of consultation outlining our proposal to remove the medicinal ingredient or the medicinal ingredient for certain conditions of use from the PDL. We also put the NDS or SNDS on “switch hold”.
  8. After a 75-day PDL consultation period, Health Canada reviews the comments received from the public and other stakeholders.
  9. After analyzing the comments, if Health Canada decides to proceed, we post a notice of intent announcing that the amendment to the PDL will occur in 6 months’ time. Then we issue the applicant a notification of potential reclassification.
  10. The applicant submits a PLA in accordance with the NHPR reflecting the NDS or SNDS information in anticipation of the PDL amendment.
  11. Health Canada verifies the PLA.
  12. After the 6-month transition period, Health Canada amends the PDL and posts a notice of amendment.
  13. Health Canada issues the applicant a notification of reclassification, which outlines that there is no authority to continue with the assessment of the NDS or SNDS because the product is no longer a drug under the FDR.
  14. If the applicant has satisfied the requirements of the NHPR, Health Canada also issues the product licence and natural product number (NPN) for the product.
  15. If in addition to the product licence and NPN, the appropriate SL has been issued to those conducting activities related to the product (that is, manufacturing, importing, packaging and/or labelling), the product can be sold in Canada in accordance with the NHPR.

Flowchart 2: A successful Rx to NHP switch

Flowchart 2

Text description

A shorter version of  steps for the process 2 are illustrated in a flowchart:

  1. The applicant participates in a pre-submission meeting with Health Canada.
  2. The applicant submits an NDS or SNDS for assessment.
  3. Following a successful NDS or SNDS, Health Canada proposes an amendment to the PDL.
  4. Health Canda posts a Notice of Consultation related to the proposed amendment to the PDL.
  5. After analyzing the comments, if Health Canada decides to proceed, Health Canada posts a Notice of Intent announcing that the PDL will be amended in 6 months’ time.
  6. In anticipation of the PDL amendment, the applicant files a PLA respecting the requirements of the NHPR and ensures the relevant SLs are in place.
  7. After the 6 months, Health Canada amends the PDL and posts a Notice of Amendment.
  8. If the NHPR requirements are met, Health Canada issues a Product Licence and an NPN for the NHP.
  9. Once the relevant SL (s) are in place, the applicant can market the NHP.

Additionally, the image shows that steps 1 to 7 of this process occur while the product falls under the FDR; steps 8 and 9 are under the NHPR; and steps 3, 4, 5 and 7 are part of the PDL amendment process.

Process 3: The assessment of submission leads to a negative decision

Not all switch submissions will be successful. Process 3 outlines what would occur during the NDS or SNDS assessment if the applicant is unsuccessful. This is also illustrated in Flowchart 3.

Process 3:

  1. Health Canada issues a notice of deficiency (NOD) or a notice of non-compliance (NON) if the applicant has not demonstrated in the NDS or SNDS that the proposed product meets the requirements of the FDR. This includes those related to the product’s:
    • safety, efficacy and quality
    • labelling

The applicant must successfully demonstrate that the PDL principles and factors do not apply to the proposed product with its proposed labelling. If the applicant cannot successfully demonstrate this, the proposed product could only be authorized as a prescription drug. However, because the applicant included non-prescription labelling in the submission, it would not meet the labelling requirements for prescription drugs. Thus, the proposed product cannot be authorized as a prescription drug based on this submission.

  1. The applicant responds to the NOD/NON or cancels the submission.
  2. If the applicant responds, Health Canada assesses the response:
    • If the response does not satisfactorily address the issues, Health Canada issues a NOD-Withdrawal (NOD-W) or NON-Withdrawal (NON-W). There is no change to the PDL.
    • If the response satisfactorily addresses the issues, the switch process would continue (as described in Process 1 for successful Rx to NPD switches or in Process 2 for successful Rx to NHP switches).

For more information on NODs, NONs, NOD-Ws and NON-Ws, consult:

Flowchart 3: The assessment of the submission leads to a negative decision

Flowchart 3

Text description

The steps for process 3 just described are illustrated in a flowchart.

Some other examples of where a switch may fail include:

Requesting a pre-submission meeting (all switches)

Before filing an NDS or an SNDS, the applicant is strongly encouraged to request a pre-submission meeting with Health Canada.

This is an opportunity for the applicant to ask questions related to the adequacy of their evidence in support of the proposed switch and the request for market authorization. For example, before undertaking clinical trials or consumer use studies, the applicant is encouraged to meet with Health Canada. Pre-submission meetings are also an opportunity to discuss risk management plans (RMPs), if relevant to the switch.

Note: It is possible for a company to have more than 1 pre-submission meeting.

For information on requesting pre-submission meetings for an NDS or SNDS, consult:

For Rx to NPD switches, in the pre-submission meeting, the applicant will meet with staff from:

For Rx to NHP switches, in the pre-submission meeting, the applicant will meet with staff from:

For all switches, staff from the NPD assessment area will lead pre-submission meetings.

Assembling the NDS or SNDS (all switches)

Submission type

The applicant assembles an NDS or an SNDS requesting the switch and the market authorization for the proposed product. The type of submission required depends on the specific situation. Refer to Table 1 for help in determining which type of submission to provide.

Table 1: Determining submission type
Product to be switched Situation Type of submission to file

None, as no authorized prescription drug product exists

The applicant’s proposed switch is not related to a currently authorized prescription drug product.

However, the switch relates to a medicinal ingredient already on the PDL.

File an NDS as per section C.08.002 of FDR.

A “Division 1” prescription drug product

The proposed switch relates to the applicant’s currently authorized Division 1 prescription drug product.

File an NDS as per section C.08.002 of the FDR as, in most instances, this switch represents a change in the conditions of use in Canada (namely, the sale of the product in a non-prescription setting without practitioner oversight) for which safety and effectiveness have not been established.

A “Division 8” prescription drug product

If the switch of the applicant’s prescription drug product is successful, there will be 2 products on the market:

  • the authorized Division 8 prescription drug product for some of its original conditions of use
  • the proposed NPD or NHP for other conditions of use

File an NDS, as per section C.08.002 of FDR, for the proposed NPD or NHP, as it will be an additional product introduced to the market. (Future changes to the NPD or NHP can be tracked against the new authorization separate from the prescription drug market authorization.)

If the switch is successful, the applicant will also need to file an SNDS for their authorized prescription drug product to reflect that some of its conditions of use have been removed.

If the switch of the applicant’s prescription drug product is successful, the authorized Division 8 prescription drug product (with or without changes) will become an NPD or NHP.

In other words, there would be no prescription drug product on the market at the end of the process.

File an SNDS, as per section C.08.003 of the FDR.

Submission content

In the NDS or SNDS, the applicant includes the:

Evidence of safety, efficacy and quality

For both Rx to NPD and Rx to NHP switches, the applicant files an NDS or SNDS, in which they provide evidence to demonstrate the safety, efficacy and quality of the proposed product. The evidence requirements will depend on the type of switch the applicant is proposing, as outlined in the text that follows.

The applicant proposes a switch of an authorized prescription drug product without changes

Generally, in this type of switch, the product’s safety, efficacy and quality have already been demonstrated in the submission(s) for the authorized prescription drug product. (The only condition of use that changes is the context in which the product is going to be sold.)

At a minimum, the applicant provides:

The applicant proposes the switch of an authorized prescription drug product that includes additional changes to its conditions of use

The conditions of use of an authorized prescription drug product are specified in the product monograph or prescribing information. If the applicant proposes changes to the conditions of use and/or the chemistry and manufacturing as part of the switch, additional evidence will be required.

Examples of how the proposed NPD or NHP could differ from the authorized prescription drug product include changes to:

The nature of the changes to the product and the conditions of use will determine what supportive evidence is required. For example, a new indication would require evidence from phase 3 clinical trial(s). If applicable, the applicant can build on the data previously submitted to Health Canada for the authorized prescription drug product.

The applicant is encouraged to seek guidance from Health Canada on the need for and scope of the data that would be required.

The applicant proposes a switch and does not own a related authorized prescription drug product

In these instances, the applicant provides a full data package to demonstrate the safety, efficacy and quality of the proposed product.

Outdated data

Applicants should be aware that additional data may be required if they are relying on safety, efficacy or quality studies that were generated by investigations that do not meet current standards for safety, efficacy or quality assessments. Applicants are encouraged to discuss this type of issue with Health Canada in a pre-submission meeting.

Further information

For more information on the evidence of safety, efficacy and quality that is required, consult:

The PDL Principles and factors assessment for inclusion in the NDS or SNDS

When completing the PDL principles and factors assessment, the applicant should follow the guidance provided in the following sections:

This is key for a successful switch.

Applicants should use the template provided and include the completed assessment in the NDS or SNDS.

Labelling for inclusion in the NDS or SNDS

For both Rx to NPD switches and Rx to NHP switches, the applicant follows all the requirements regarding labelling of NPDs when preparing the labels for inclusion in the NDS or SNDS. This includes providing a Canadian product monograph.

Consult relevant documents on labelling and product monographs.

As discussed in the section on Consumer use studies, the applicant conducts their studies using a label that closely reflects the final label that consumers will see on the market. This will help ensure the data from the consumer use studies accurately reflect how well consumers will be able to understand and apply the “final” labelling information.

For Rx to NPD switches, the labelling must include a Canadian Drug Facts Table (CDFT). For information on CDFT formats and flexibilities, consult:

For Rx to NHP switches, the applicant should include a Product Facts Table in their consumer use studies and in the NDS or SNDS, if the Product Facts Table is required on the final NHP label. For information on Product Facts Table requirements, flexibilities and exemptions, consult:

Formatting and filing the NDS or SNDS (all switches)

When formatting the submission, the applicant should follow the instructions in:

Applicants should also include the PDL principles and factors assessment in Module 1.0.7, the consumer use studies in Module 5 and the summary of the consumer use studies in Module 2.

If there is a prescription drug product that is being switched and it was authorized as the result of a paper submission, Health Canada encourages the applicant to re-submit electronically any relevant evidence from the earlier submission(s) in their switch submission. This will facilitate the review.

For more information on filing, consult:

Paying fees (all switches)

All applicants pay cost-recovery fees for the assessment of the information submitted in their NDS or SNDS.

This includes applicants seeking an Rx to NHP switch, which must begin under the FDR in light of subsection 2(2) of the NHPR. Their proposed product can only move to the NHPR if the NDS or SNDS results in the medicinal ingredient being removed from the PDL.

Note: The content of the NDS and SNDS determines the size of the fee and associated performance standard, not whether it is an NDS or SNDS. For example, in 2021, the fee was $224,242 for a switch that required clinical or non-clinical as well as chemistry and manufacturing data but did not include a new active substance.

The relevant fees for product assessment are found in Schedule 1 of the Fees in Respect of Drugs and Medical Devices Order.

For more information on fees, fee categories and fee mitigation measures, consult:

Health Canada screens the submission for deficiencies

Health Canada screens submissions and if there are deficiencies, issues a screening deficiency notice (SDN). For more information, consult:

Health Canada assesses the NDS or SNDS

Assessment

Health Canada assesses the NDS or SNDS, including the applicant’s PDL principles and factors assessment, to determine if the applicant has successfully demonstrated that the:

Internal decision-making process for PDL amendments

If the applicant has successfully demonstrated the 2 items listed in the previous section, the department’s scientific staff will propose to the Prescription Drug Status Committee (PDSC) that the PDL be amended for the switch.

The PDSC is an internal committee of scientific and medical experts. Its role is to make recommendations on all proposed PDL amendments to the Director General (DG) of the PDD who has the delegated authority from the Minister of Health for decisions on amendments to the PDL.

The committee’s core members are from the NNHPD, Marketed Health Products Directorate, PDD, Veterinary Drugs Directorate and Biologic and Radiopharmaceutical Drugs Directorate. Members from other directorates participate as needed.

If the PDSC agrees with the proposal to amend the PDL, it recommends this course of action to the DG of PDD. The DG makes the final decision on initiating the process for the PDL amendment for the switch, taking into consideration the recommendations of the PDSC.

Health Canada consults the public

If the DG endorses the switch proposal, the amendment process begins. This includes a consultation as required by section C.01.040.4 of the FDR.

For more information on the PDL and the PDL amendment process, consult:

For switches, Health Canada consults the public and other stakeholders on the proposed amendment to the PDL. We do this by posting a notice of consultation on the Government of Canada website.

In this notice, Health Canada outlines the proposed amendment to remove the medicinal ingredient or the medicinal ingredient for certain conditions of use from the PDL. For example, a medicinal ingredient could be removed from the PDL for only some indications or at lower doses. The notice also includes the rationale for the switch, the conditions of use and a list of affected products.

At the same time, Health Canada places the NDS or SNDS on switch hold (a temporary pause on the progress of the submission) pending the outcome of the consultation and PDL amendment process. The reason for this is that until the PDL is modified, the:

Health Canada announces its intention to amend the PDL

After the 75-day public consultation, Health Canada analyzes the comments received. Depending on the nature of the comments and the issues raised, the analysis could result in Health Canada deciding to do one of the following:

Proceed

If the results of the analysis support a decision to proceed with the amendment process, Health Canada publishes a notice of intent. This notice specifies the date, 6 months later, when the amendment of the PDL will occur. The 6-month transition period is a delayed implementation period in accordance with the international Technical Barriers to Trade (TBT) Agreement.

The transition period also provides market authorization holders of other affected products with time to comply with the upcoming new regulatory requirements (such as revised labelling). For more details, refer to the section on Impact of a switch on other prescription drug products.

For Rx to NHP switches:

Modify

If the proposal needs to be modified, depending on the nature of the modification, Health Canada either:

In the past, modifications have ranged from minor changes in the wording of the qualifier to significant re-working of the proposal. Health Canada communicates these plans to the applicant before publishing a notice of intent or a new notice of consultation.

Stop

If the analysis results in Health Canada deciding not to pursue the amendment, we:

Note: The next sections of the document are for the scenario where Health Canada has decided to proceed with the PDL amendment.

Filing the product licence application (Rx to NHP switches only)

After Health Canada posts the notice of intent, the applicant provides a product licence application (PLA) to obtain an NHP product licence and an NPN. This can be either during or after the 6-month transition period, as we are willing to contemplate whether the PLA would meet the NHPR requirements prior to the PDL amendment. However, decisions under the NHPR can only be made after the PDL is amended and the NHPR apply to the product.

The applicant provides a PLA as outlined in the Natural health products management of applications policy. There are currently no fees for assessing the PLA. The cost-recovery program for NHPs is under development.

The applicant completes the web-based PLA form (including the label). This involves accurately reflecting the information in the latest version of the labelling (including the Canadian product monograph) agreed to by Health Canada during the NDS or SNDS assessment.

The applicant should neither resubmit the evidence that was submitted as part of the NDS or SNDS nor resubmit the PDL Principles and Factors Assessment. This information, already with Health Canada, will be considered as part of the PLA.

Instead, the applicant indicates in the cover letter of the PLA that evidence in support of the NHP product licence is contained in their NDS or SNDS. The applicant also includes the control number assigned to the NDS or SNDS in the cover letter.

Applicants wishing to obtain their product licence and NPN promptly after the PDL is amended should provide their PLA within 60 days of the notice of intent being published.

Health Canada verifies the PLA (Rx to NHP switches only)

Health Canada verifies the PLA to confirm it:

Health Canada amends the PDL

After the 6-month transition period, Health Canada amends the PDL. We then post the notice of amendment on the Government of Canada website to announce that the amendment to the PDL has occurred.

Health Canada issues the market authorization

Rx to NPD switches

Situations requiring a new DIN

A new DIN is required if any of the following apply:

In the last situation, if a new DIN is required, the applicant submits a notification of discontinuation of sale to Health Canada for the previously assigned DIN. The notification must be sent within 30 days of the cessation of sale. We then cancel the previously assigned DIN.

Market authorization (Rx to NPD switch)

Health Canada sends the applicant a drug notification form (DNF) in relation to the new NPD. We also issue the applicant an NOC for the NPD and an acknowledgement of the final approved version of Canadian product monograph. With the issuance of both a DIN and an NOC, the product is market-authorized.

Rx to NHP switches

Resolution of the NDS or SNDS

After the PDL is amended, Health Canada issues the applicant a notification of reclassification outlining that the:

In cases where no prescription drug product will remain on the market after the amendment, Health Canada also cancels the DIN(s) for the prescription drug product.

Market authorization (Rx to NHP switch)

After the PDL is amended, Health Canada issues a product licence and assigns the NPN if the applicant has done the following:

The timing for issuance of the market authorization for an applicant who has met the requirements depends on when they applied. Specifically:

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