MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023

MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023

Health Canada

 

PMRA Annual Fees reduced for Reporting and Applications:

Health Canada is implementing a new approach beginning April 1, 2023. The PMRA will no longer contact registrants who fail to submit their volumetric sales report by the June 1st deadline. Registrants who do not submit their volumetric sales report by the June 1st deadline will face the Pest Control Products Act (PCPA) enforcement actions, which may include warning letters, compliance orders, court orders, and a recommendation to the Public Prosecution Service of Canada for prosecution.

PMRA sent a one-time notice to Registrant Contacts in mid-February this year to finish the Sales report for the 2022 calendar year.

PMRA charges an annual fee of approximately $4,000 per registration. If the Registrants have made fewer sales, they may be eligible for lower annual fees. This year, PMRA will send Annual Charge Packages to registrants at the end of February. The application deadline for reduced fees is April 1st, 2023.

As of April 1st, 2023, Medical Device fees will be Increasing:

 

Fee Type

2022 fee’s

2023 fee’s

1

Applications for Class II licence

$522

$589

2

Applications for Class II licence amendment or applications to amend Class II authorization

$282

$302

3

Applications for Class III licence

$10,679

$12,987

4

Applications for Class III licence (near patient)

$20,723

$27,666

5

Applications for Class III licence amendment or applications to amend Class III authorization – changes in manufacturing

$3,070

$4,098

6

Applications for Class III licence amendment or applications to amend Class III authorization – significant changes not related to manufacturing

$8,780

$10,425

7

Applications for Class IV licence

$25,955

$28,165

8

Applications for Class IV licence amendment or applications to amend Class IV authorization– changes in manufacturing

$3,070

$4,098

9

Applications for Class IV licence amendment or applications to amend Class IV authorization – significant changes not related to manufacturing

$12,128

$14,902

10

Applications for Class II, III or Class IV licence, applications to amend such a license or applications to amend Class II, III or Class IV authorization – private label medical device

$152

$163

11

Medical Device Right to Sell Class II, III or IV

$394

$421

12

Application for a new licence and annual review of licence

$4737

$5060

Drug Establishment Licence Fees – Drugs for Human and Veterinary Use
FeeFee Amount in 2022-2023
(CAD $)
Fee Amount in 2023-2024
(CAD $)
Human use – Fabrication – Sterile dosage form43,17146,221
Human use – Importation31,68835,688
Human use – Fabrication – Non-sterile dosage form30,67734,266
Human use – Distribution15,69118,215
Human use – Wholesaling7,96210,630
Human use – Packaging/labelling6,2556,681
Human use – Testing4,1295,514
Human use – Building outside Canada (each)9491,014
Veterinary use – Fabrication – Sterile dosage form42,08045,262
Veterinary use – Importation17,27823,066
Veterinary use – Fabrication – Non-sterile dosage form14,16118,905
Veterinary use – Distribution7,79710,409
Veterinary use – Wholesaling3,1174,161
Veterinary use – Packaging/labelling6,2556,681
Veterinary use – Testing2,1212,833
Veterinary use – Building outside Canada (each)9491,014
Drug Establishment Licence Fees – Dealer’s Licence
FeeFee Amount in 2022-2023
(CAD $)
Fee Amount in 2023-2024
(CAD $)
Dealer’s Licence Fees – Human Drugs5,6135,726
Dealer’s Licence Fees – Veterinary Drugs1,882.522,010.53
Dealer’s Licence Fees – Veterinary Drugs (first year)941.261,005.27
Fees for the Examination of a Submission – Drugs for Human Use
FeeFee Amount in 2022-2023
(CAD $)
Fee Amount in 2023-2024
(CAD $)
New active substance490,666565,465
Clinical or non-clinical data and chemistry and manufacturing data253,015292,806
Clinical or non-clinical data only104,339117,080
Comparative studies59,70865,985
Chemistry and manufacturing data only34,83140,597
Clinical or non-clinical data only, in support of safety upgrades to the labelling20,06421,429
Labelling only4,9975,901
Labelling only (generic drugs)2,0752,217
Administrative submission698933
Disinfectant – Full review9,21112,297
Labelling only (disinfectants)2,5882,764
Drug identification number application – Labelling standards1,6681,782

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

We also have regulatory solutions for; OTC drugs, DIN Numbers, DEL, Veterinarian products, Food, and more.

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