Performance Standards for the Fees in Respect of Drugs and Medical Devices Order

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This document provides the performance standards to be used to determine whether a remission should be granted, under the Fees in Respect of Drugs and Medical Devices Order (Order), to a person who must pay a fee under that Order.

The Guideline on Service Standards developed by the Treasury Board of Canada Secretariat defines a service standard as follows: a service standard is a public commitment to a measurable level of performance that clients can expect under normal circumstances.

Further to consultations from October 2017 to June 2018, Health Canada has established the following performance standards in relation to fees that are payable under the Order. The standards appropriately reflect the department's ability to deliver its service(s) within a set timeframe.

This document was originally published on November 22, 2018. The following updates have been made:

  • November 1, 2022, to reflect changes to the fee category definitions in the Order
  • September 11, 2023, to reflect changes to the fee category descriptions in the Order
  • February 16, 2024, to reflect the introduction of biocides fees to the Order

For the Fees in Respect of Drugs and Medical Devices Order, the following performance standards apply to fees for drugs, biocides and medical devices.

Fees for examination of a submission – Drugs for human use
  Submission class Description Performance Standard

1

New active substance

Submissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph

300 calendar days to complete Review 1Table 1 Footnote *

2

Clinical or non-clinical data and chemistry and manufacturing data

Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance

For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1Table 1 Footnote *

For drugs under Division 8 of the Food and Drug Regulations: 300 calendar days to complete Review 1Table 1 Footnote *

3

Clinical or non-clinical data only

Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance

For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1Table 1 Footnote *

For drugs under Division 8 of Food and Drug Regulations: 300 calendar days to complete Review 1Table 1 Footnote *

4

Comparative studies

Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance

For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1Table 1 Footnote *

For drugs under Division 8 of Food and Drug Regulations: 180 calendar days to complete Review 1Table 1 Footnote *

5

Chemistry and manufacturing data only

Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance

For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1Table 1 Footnote *

For drugs under Division 8 of Food and Drug Regulations: 180 calendar days to complete Review 1Table 1 Footnote *

6

Clinical or non-clinical data only, in support of safety updates to the labelling

Submissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance

120 calendar days to complete Review 1Table 1 Footnote *

7

Labelling only

Submissions, other than those described in item 8, 11 or 12, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data or chemistry and manufacturing data)

120 calendar days to complete Review 1Table 1 Footnote *

8

Labelling only (generic drugs)

Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment

120 calendar days to complete Review 1Table 1 Footnote *

9

Administrative submission

Submissions in support of a change in the manufacturer's name or brand name, including the following: changes in ownership of the drug; request for an additional brand name; changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor's drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act)

45 calendar days to review

10

Disinfectant — full review

Submissions, other than those described in item 11, that include data in support of a disinfectant

For drugs under Division 1 of the Food and Drug Regulations: 180Table 1 Footnote ** or 210 calendar days to complete Review 1Table 1 Footnote *

For drugs under Division 8 of Food and Drug Regulations: 300 calendar days to complete Review 1Table 1 Footnote *

11

Labelling only (disinfectants)

Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer's name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug

90 calendar days to complete Review 1Table 1 Footnote *

12

Drug identification number application — labelling standards

Applications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data

60 calendar days to complete Review 1Table 1 Footnote *

Table 1 Footnote *

Review 1 is the period from the date of acceptance to the date of the first decision (Notice of Deficiency, Notice of Non-compliance, Notice of Compliance with Conditions or Notice of Compliance).

Table 1 Return to footnote * referrer

Table 1 Footnote **

The 180 calendar days to complete Review 1 is a Label Only assessment that does not include the submission of data. It relies on bridged / cross-referenced data from other submissions.

Table 1 Return to footnote ** referrer

Fees for examination of a submission – Drugs for veterinary use onlyTable 2 Footnote **
  Type of submission Description Performance Standard

1

Application for drug identification number

Components included in an application as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

120 calendar days to complete Review 1Table 2 Footnote *

2

Notification — veterinary health product

Information contained in a notification filed under subsection C.01.615 (1) of the Food and Drug Regulations in respect of a veterinary health product

30 calendar days to process notification

3

New drug submission

Components included in a submission as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

300 calendar days to complete Review 1Table 2 Footnote *

4

Supplement to a new drug submission

Components included in a submission as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

240 calendar days to complete Review 1Table 2 Footnote *

5

Abbreviated new drug submission

Components included in a submission as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

300 calendar days to complete Review 1Table 2 Footnote *

6

Supplement to an abbreviated new drug submission

Components included in a submission as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

240 calendar days to complete Review 1Table 2 Footnote *

7

Preclinical submission

Components included in a submission as set out in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order

60 calendar days to review application

8

Sale of new drug for emergency treatment

Information and material to support the sale of a drug to be used in the emergency treatment of a food or non-food-producing-animal

2 business days to review application

9

Experimental studies certificate

Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food or non-food-producing-animal

60 calendar days to review application

10

Notifiable change

Information and material to support an application for a notifiable change

90 calendar days to review application

11

Protocol

A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate

90 calendar days to review package

Table 2 Footnote *

Review 1 is the period from the date of acceptance to the date of the first decision (Notice of Deficiency, Notice of Non-compliance, Notice of Compliance with Conditions or Notice of Compliance).

Table 2 Return to footnote * referrer

Table 2 Footnote **

While there are individual fees for each component and a submission / application can be made up of more than one component, the submission / application is reviewed as one package.

Table 2 Return to footnote ** referrer

Fees for examination of an application – Biocides
  Class Description Performance Standard
1 Biocide full review - novel biocide An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application based on a comparison referred to in item 7, if the biocide has a novel active ingredient, a novel combination of active ingredients, or a novel physical form, use, purpose or method of application. 300 calendar days to complete Review 1Table 3 Footnote *
2 Biocide full review – tier I An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 25 or fewer reports of tests and studies with respect to efficacy data. 180 calendar days to complete Review 1Table 3 Footnote *
3 Biocide full review – tier II An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 26 to 50 reports of tests and studies with respect to efficacy data. 195 calendar days to complete Review 1Table 3 Footnote *
4 Biocide full review – tier III An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains at least 51 reports of tests and studies with respect to efficacy data. 210 calendar days to complete Review 1Table 3 Footnote *
5 Biocide comparison — labelling only An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison and requires a review of labelling. 90 calendar days to complete Review 1Table 3 Footnote *
6 Biocide comparison — administrative application An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison between the biocide and another biocide that is the subject of a market authorization where only the brand name of the biocide, the name of the applicant or the name of the holder of the market authorization, or any combination thereof, differs from the corresponding information in respect of the other biocide. 45 calendar days to review
7 Biocide - Use of foreign decisions An application for a market authorization that is based on a comparison between the biocide and a biocide that is authorized for sale by a foreign regulatory authority or an application for a notice of acceptance in respect of a major change to the biocide that is the subject of such a market authorization. 90 calendar days to complete Review 1Table 3 Footnote *
8 Biocide monograph An application for a market authorization or for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and requires supporting information for aspects of the biocide that are outside the parameters of the monograph. 60 calendar days to review
9 Biocide major change —monograph An application for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and that does not require supporting information because the aspects of the biocide that are impacted by the change are within the parameters of the monograph. 30 calendar days to review
10 Biocide major change – quality and risks An application for a notice of acceptance in respect of a major change that does not include reports of tests and studies with respect to efficacy data. 60 calendar days to review
11 Biocide minor change The examination of a written description of a minor change. 30 calendar days to review
Table 3 Footnote *

Review 1 is the period from the date of acceptance to the date of the first decision (Notice of Deficiency, Notice of Non-compliance, Notice of Compliance with Conditions or Notice of Compliance).

Table 3 Return to footnote * referrer

Fees for Examination of an application for an establishment licence – Drugs for human use and / or veterinary use only
Fee name Description Performance Standard

Drug Establishment Licence

Activity

  • Fabrication – sterile dosage form
  • Importation
  • Fabrication – nonsterile dosage form
  • Distribution
  • Wholesaling
  • Packaging/labelling
  • Testing
Application for new licence, annual review of licence, or amendment to a licence to add a new building in Canada 250 calendar days to issue decision
Fees for right to sell drugs for human use
Fee name Description Performance Standard
Right to Sell Drugs for Human Use The annual fee for the right to sell a drug (Disinfectant, Non-prescription drug, or a Drug other than one referred to earlier) for which a drug identification number has been assigned under section C.01.014.2 (1) of the Food and Drug Regulations 20 calendar days to update Drug Product Database following receipt of a complete Annual Notification Package
Fees for right to sell drugs for veterinary use only
Fee name Description Performance Standard
Right to Sell Drugs for Veterinary Use Only The annual fee for the right to sell a drug for veterinary use only for which a drug identification number has been assigned under section C.01.014.2 (1) of the Food and Drug Regulations 20 calendar days to update Drug Product Database following receipt of a complete Annual Notification Package
Fees for right to sell biocides
Fee name Description Performance Standard
Right to Sell Biocides The annual fee for that is payable for the right to sell a biocide for which a market authorization has been issued under section 11 of the Biocides Regulations 20 calendar days to update biocides database following receipt of annual notification of sale
Fees for examination of an application for licence, amendment application for licence or application to amend authorization — Medical devices
  Category Description Performance Standard

1

Applications for Class II licence

Applications for Class II medical device licence other than those referred to in item 10

15 calendar days to review

2

Applications for Class II licence amendment or applications to amend Class II authorization Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 15 calendar days to review

3

Applications for Class III licence

Applications for Class III medical device licence other than those referred to in item 4 or 10

60 calendar days to complete Review 1Table 6 Footnote *

4

Applications for Class III licence (near patient)

Applications for Class III medical device licence for a near patient in vitro diagnostic device

60 calendar days to complete Review 1Table 6 Footnote *

5

Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — changes in manufacturing process, facility or equipment or manufacturing quality control procedures

60 calendar days to complete Review 1Table 6 Footnote *

6

Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — significant changes other than those referred to in item 5

60 calendar days to complete Review 1Table 6 Footnote *

7

Applications for Class IV licence Applications for Class IV medical device licence other than those referred to in item 10

75 calendar days to complete Review 1Table 6 Footnote *

8

Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturing Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device — changes referred to in paragraph 34(a) or 68.13 (a) of the Medical Devices Regulations that relate to manufacturing

75 calendar days to complete Review 1Table 6 Footnote *

9

Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes
not related to manufacturing
Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for Class IV medical device that is not a UPHN medical device — any other changes referred to in paragraph 34(a) or (b) or 68.13 (a) or (b) of the Medical Devices Regulations

75 calendar days to complete Review 1Table 6 Footnote *

10

Applications for Class II, III or IV licence, applications to amend such a licence or applications to amend Class II, III, IV authorization — private label medical device Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or IV medical device that is not a UPHN medical device — private label medical device

15 calendar days to review

Table 6 Footnote *

Review 1 is the period from the date of acceptance of an administratively complete application to the date of the first decision (for Class II and Private Label Applications: Licence, Screening Deficiency Letter, Rejection Letter, Withdrawal; for Class III and IV: Licence, Additional Information Request, Refusal Letter, or Withdrawal).

Table 6 Return to footnote * referrer

Fees for examination of an application for a Medical Device Establishment Licence
Fee Name Description Performance Standard
Medical Device Establishment Licence Applications for new licence and annual review of licence 120 calendar days to issue decision
Fees for Right to sell Licensed or authorized Class II, III or IV medical devices
Fee Name Description Performance Standard
Right to Sell Medical Device The annual fee for the right to sell a licensed Class II, III or IV medical device or an authorized Class II, III or IV medical device that is not a UPHN medical device 20 days to update Medical Device Licence Listing database following receipt of a complete Annual Notification Package

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