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Guidance on switching from prescription to non-prescription status: Additional information

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Timelines for the switch process

Table 2 shows the timelines for the different stages of the switch process.

The timeframes shown for parts B and D are for straightforward cases. These timeframes may need to be longer for complex cases (for example, when major concerns are raised during the consultation).

Table 2: Timelines for the stages of a successful switch process
Stage in the process Timeline

A. From the submission filing date to Health Canada having reviewed the NDS or SNDS submission and written a summary document for the PDSC

Appendix 3 of Management of drug submissions and applications sets out the performance standards for assessing submissions.

B. From the end of submission review to Health Canada posting the notice of consultation

3 months

C. PDL consultation period

75 calendar days

D. From the end of the consultation period to Health Canada posting the notice of intent indicating the PDL will be amended

1 month

E. From Health Canada posting the notice of intent to Health Canada posting the notice of amendment (the transition period)

6 months

F. From Health Canada posting the notice of amendment to Health Canada issuing the market authorization

1 or 2 business days for the NOC in the case of Rx to NPD switches

1 or 2 business days for the NHP product licence in the case of Rx to NHP switches if the applicant applied early, etc. (Refer to the section Market authorization (Rx to NHP switch) for more details).

Reconsiderations

Applicants wishing to request a reconsideration of a negative decision (for example, a NON-W or NOD-W) issued by Health Canada with respect to the market authorization request for an Rx to NPD or Rx to NHP switch should consult:

Switches involving products with multiple medicinal ingredients on the PDL

If the applicant’s proposed NPD or NHP contains more than 1 medicinal ingredient listed on the PDL, the applicant needs to:

Switches involving medical devices

For a product classified as a drug-device combination product according to the policy on drug/medical device combination products, the applicant is encouraged to contact Health Canada to discuss switch requirements and applicable authorizations.

When a switch involves the use of a medical device that is not part of a combination product, such as an independent drug-delivery device or monitoring device, the applicant must ensure the medical device is authorized where required by the Medical Devices Regulations (MDR).

Additionally, if the use of the proposed product relies on the use of a particular medical device, the device should be consumer-friendly and usable without practitioner intervention. That is, the consumer should be able to:

Any human factors or usability assessments of the medical device components and formally conducted with health care professionals or specialized health technicians should be repeated with representative consumer test groups. This is done to confirm that the medical device design remains optimal for the new user population.

The proposed product would not be suitable for self-care and a switch if the following both apply:

For additional guidance on what to submit related to the medical device in a switch submission, contact the Medical Devices Directorate by email: meddevices-instrumentsmed@hc-sc.gc.ca.

GMP, DEL and SL requirements

In addition to obtaining a product market authorization for an NPD or NHP pursuant to a switch, there are GMP, DEL and SL requirements that must be met for products to be sold in Canada.

Rx to NPD switches

Prescription and non-prescription drugs are subject to:

If the applicant or other parties conducting licensable activities (such as fabrication or importation) on the applicant’s behalf already comply with the relevant DEL and GMP requirements, no change to the DEL is required. If they do not already comply, they need to ensure compliance with the DEL and GMP requirements before they sell the NPD in Canada.

In terms of filing the NDS or SNDS, the applicant is reminded to comply with the following notice:

Note: Wholesaling an NPD does not require a DEL, but must still meet GMP requirements as per Part C, Division 2 of the FDR.

For more information, consult:

Rx to NHP switches

Normally at the beginning of an NDS or SNDS review, Health Canada screens the submission for the DEL, GMP compliance rating or DEL applications as outlined in Submission filing requirements - Good manufacturing practices (GMP)/drug establishment licences (DEL). However, because an Rx to NHP switch moves the product from FDR to the NHPR, we defer this screening until later in the assessment process.

To market the NHP in Canada, the switch applicant or other parties who are carrying out activities such as manufacturing are required to follow GMP, as per Part 3 of the NHPR. Also, the switch applicant or other parties must obtain a site licence (SL), as per section 2 of the NHPR, for the activities of manufacturing, packaging, labelling and /or importing.

There are 3 possible scenarios in relation to the SL for the applicant or other parties carrying out the activities:

The applicant or other parties must obtain an SL before marketing the NHP. Performance standards for SL issuance are listed in Table 1 of section 3.1.1 Application completion timelines of the Site licensing guidance document.

For additional guidance on the SL and NHP GMP requirements, consult:

If the Rx to NHP switch involves an authorized prescription drug product that will become an NHP with the prescription drug product no longer being marketed, the FDR DEL requirements continue to apply to the prescription drug product:

Once 1 of these 2 criteria is met, the DEL holder may submit a request for DEL cancellation. 

Note: The timeline for the applicable GMP requirements (for example, records and samples retention) continues beyond the holding of the DEL. All relevant evidence is required to be kept for 1 year beyond the expiration date of the product.

Intellectual property

For information on the data protection provisions of the FDR or on the Patented Medicines (Notice of Compliance) Regulations:

The impact of a switch on other prescription drug products

In Canada, a successful switch results in an amendment to the PDL. This can have an impact on other prescription drug products (for example, on generic versions of the reference drug product). Companies that are not the initiator of the switch need to assess if a proposed amendment to the PDL would mean their products will also no longer be prescription, and prepare themselves accordingly.

Where the switch results in the medicinal ingredient being entirely removed from the PDL, the affected companies would no longer be able to sell their products as prescription drug products. However, they could file a submission/application to obtain their market authorization as a non-prescription status product (NPD or NHP).

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

Health Canada will provide companies with details on all their options before launching the consultation.

Note that the submissions or applications from affected companies are not considered “switch submissions”.

Other companies interested in marketing products given the PDL amendment

Other companies may become aware, based on the PDL notices, that the PDL is being amended to remove a medicinal ingredient or a medicinal ingredient for specific conditions of use. Companies that do not have a related prescription drug product affected by the switch may wish to market a new NPD or NHP with this medicinal ingredient and under the specified conditions of use.

Conditional on a PDL amendment, these companies would file either an NDS or an abbreviated new drug submission (ANDS) for an NPD or a Class III application for an NHP to obtain a market authorization. As long as the proposed new product aligns with the PDL amendment, these submissions/applications can follow the normal submission process with the regular requirements. They are not “switch submissions”.

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2024-08-14