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

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The purpose of this document is to provide 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.

For the purposes of the Fees in Respect of Drugs and Medical Devices Order, to come into force on April 1, 2020, below are the performance standards applicable to fees for drugs 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 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 Examination of an Application for a Medical Device Licence

  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

Applications for amendment of Class II medical device licence other than those 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 — changes in manufacturing

Applications for amendment of Class III medical device licence — 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 — significant changes not related to manufacturing

Applications for amendment of Class III medical device licence — 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 — changes in manufacturing

Applications for amendment of Class IV medical device licence — changes referred to in paragraph 34(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 — significant changes
not related to manufacturing

Applications for amendment of Class IV medical device licence — any other changes referred to in paragraph 34(a) or (b) of the Medical Devices Regulations

75 calendar days to complete Review 1Table 6 Footnote *

10

Applications for Class II, III or Class IV licence or licence amendment — private label medical device

Applications for Class II, III or IV medical device licence or applications for amendment of such a licence — 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 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 20 days to update  Medical Device Licence  Listing database following receipt of a complete Annual Notification Package
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