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

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 1^{Table 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 1^{Table 1 Footnote *}

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

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

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

For drugs under Division 8 of Food and Drug Regulations: 180 calendar days to complete Review 1^{Table 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 1^{Table 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 1^{Table 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 1^{Table 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: 180^{Table 1 Footnote **} or 210 calendar days to complete Review 1^{Table 1 Footnote *}

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

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 1^{Table 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 1^{Table 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 1^{Table 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 1^{Table 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 1^{Table 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

Drug Establishment Licence

Activity

• Fabrication – sterile dosage form
• Importation
• Fabrication – nonsterile dosage form
• Distribution
• Wholesaling
• Packaging/labelling
• Testing

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

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 1^{Table 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 1^{Table 6 Footnote *}

5

60 calendar days to complete Review 1^{Table 6 Footnote *}

6

60 calendar days to complete Review 1^{Table 6 Footnote *}

7

75 calendar days to complete Review 1^{Table 6 Footnote *}

8

75 calendar days to complete Review 1^{Table 6 Footnote *}

9

75 calendar days to complete Review 1^{Table 6 Footnote *}

10

15 calendar days to review