Authority to Sell Drugs Fees Regulations
SOR/95-31
Registration 1994-12-28
Regulations Prescribing the Fees to be Paid by Certain Persons or Classes of Persons on Whom the Right or Privilege to Sell a Drug is Conferred by the Minister of National Health and Welfare by the Assignment of an Identification Number in Respect of the Drug
P.C. 1994-2170 1994-12-28
His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare and the Treasury Board, pursuant to paragraph 19.1(1)(a)Footnote * of the Financial Administration Act, is pleased hereby to make the annexed Regulations prescribing the fees to be paid by certain persons or classes of persons on whom the right or privilege to sell a drug is conferred by the Minister of National Health and Welfare by the assignment of an identification number in respect of the drug.
Return to footnote *S.C. 1991, c. 24, s. 6
Short Title
1 These Regulations may be cited as the Authority to Sell Drugs Fees Regulations.
Interpretation
2 (1) In these Regulations,
- annual wholesale sales
annual wholesale sales means the wholesale sales of a drug in the most recently completed fiscal year preceding the day on which a fee is required to be paid under these Regulations in respect of the drug; (ventes en gros annuelles)
- identification number
identification number means a number, preceded by the letters “DIN” or “GP”, that is assigned for a drug in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations. (identification numérique)
(2) All other words and expressions used in these Regulations have the meaning assigned to them by the Food and Drugs Act or the Food and Drug Regulations.
Fee
3 (1) This section applies to a person who has applied for an identification number for a drug of a type set out in column I of the schedule if
(a) an identification number has been assigned for the drug; and
(b) the person has submitted a notification under section C.01.014.3 of the Food and Drug Regulations that the drug is being sold in Canada.
(2) A person to whom this section applies shall pay, in respect of each drug referred to in subsection (1),
(a) the applicable fee set out in column II of the schedule, where the person’s annual wholesale sales of the drug in Canada are $20,000 or more; or
(b) a fee of $50, where the person’s annual wholesale sales of the drug in Canada are less than $20,000.
(3) A fee referred to in subsection (2) shall be paid annually at the time the notification under section C.01.014.5 of the Food and Drug Regulations is furnished to the Director, and is in respect of the 12-month period commencing on October 1 in the year in which it is required to be paid.
(4) This section does not apply in respect of a drug if the identification number for the drug has been cancelled pursuant to the Food and Drug Regulations.
Fee for the Transitional Period
4 (1) This section applies to a person who has applied for an identification number for a drug of a type set out in column I of the schedule if, on or before December 31, 1994,
(a) an identification number has been assigned for the drug; and
(b) the person has submitted a notification under section C.01.014.3 of the Food and Drug Regulations that the drug is being sold in Canada.
(2) A person to whom this section applies shall pay, in respect of each drug referred to in subsection (1),
(a) 75 per cent of the applicable fee set out in column II of the schedule, where the person’s annual wholesale sales of the drug in Canada are $20,000 or more; or
(b) a fee of $50, where the person’s annual wholesale sales of the drug in Canada are less than $20,000.
(3) A fee referred to in subsection (2) shall be paid within 30 days after receipt of a demand for payment from the Director, and is in respect of the transitional period commencing on January 1, 1995 and ending on September 30, 1995.
(4) This section does not apply in respect of a drug if, on or before December 31, 1994, the identification number for the drug has been cancelled pursuant to the Food and Drug Regulations.
Proprietary Medicine
5 Notwithstanding subsections 3(2) and 4(2), only one fee is payable in respect of two or more drugs that are proprietary medicines of a type set out under item 9 of the schedule if
(a) a number, preceded by the letters “ GP ”, has been assigned for each drug; and
(b) the drugs differ from each other only in flavour, fragrance or colour.
Coming into Force
6 These Regulations come into force on January 1, 1995.
SCHEDULE(Subsections 3(1) and (2) and 4(1) and (2))
FEE
| Column I | Column II | |
|---|---|---|
| Item | Types of Drugs | Fee |
| 1 | Drugs listed in Schedule F to the Food and Drug Regulations | $1,000 |
| 2 | Drugs listed in Schedule D to the Act | 1,000 |
| 3 | Drugs listed in Schedule G to the Act | 1,000 |
| 4 | Drugs listed in the schedule to the Narcotic Control Act | 1,000 |
| 5 | Homeopathic drugs | 250 |
| 6 | Drugs labelled as being for veterinary use only | 250 |
| 7 | Drugs that are labelled as being for use as a disinfectant of medical devices | 500 |
| 8 | Drugs, other than those set out in item 7, that are labelled as being for use as a disinfectant | 250 |
| 9 | Drugs of a type that is not set out in items 1 to 8 | 500 |
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