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R.R.O. 1990, Reg. 935: GENERAL

under Drug Interchangeability and Dispensing Fee Act, R.S.O. 1990, c. P.23

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Drug Interchangeability and Dispensing Fee Act
Loi sur l’interchangeabilité des médicaments et les honoraires de préparation

R.R.O. 1990, REGULATION 935

GENERAl

Consolidation Period:  From October 1, 2015 to the e-Laws currency date.

Last amendment: O. Reg. 285/15.

This Regulation is made in English only.

1. (1) In this Regulation,

“original product” means the original source of a drug product in a particular strength and dosage form;

“production size lot” means the amount of finished product that is made from the minimum quantity of raw materials specified in a formula that can be processed using full sized production equipment into a dosage form that meets the specifications for the finished product.

R.R.O. 1990, Reg. 935, s. 1; O. Reg. 235/92, s. 1; O. Reg. 460/92, s. 1; O. Reg. 757/92, s. 1; O. Reg. 101/93, s. 1; O. Reg. 318/93, s. 1 (1); O. Reg. 453/93, s. 1; O. Reg. 524/93, s. 1; O. Reg. 526/93, s. 1; O. Reg. 735/93, s. 1; O. Reg. 49/94, s. 1 (1); O. Reg. 108/94, s. 1; O. Reg. 452/94, s. 1 (1); O. Reg. 615/94, s. 1; O. Reg. 755/94, s. 1 (1); O. Reg. 792/94, s. 1; O. Reg. 40/95, s. 1; O. Reg. 305/95, s. 1; O. Reg. 371/95, s. 1; O. Reg. 479/95, s. 1 (1); O. Reg. 177/96, s. 1; O. Reg. 337/96, s. 1; O. Reg. 376/96, s. 1; O. Reg. 509/96, s. 1 (1); O. Reg. 28/97 s. 1; O. Reg. 111/97, s. 1; O. Reg. 300/97, s. 1; O. Reg. 613/98, s. 1; O. Reg. 73/99, s. 1; O. Reg. 333/99, s. 1; O. Reg. 402/99, s. 1; O. Reg. 587/99, s. 1; O. Reg. 201/00, s. 1 (1); O. Reg. 367/00, s. 1; O. Reg. 583/00, s. 1; O. Reg. 15/01, s. 1; O. Reg. 173/01, s. 1 (1); O. Reg. 359/01, s. 1; O. Reg. 63/02, s. 1; O. Reg. 215/02, s. 1; O. Reg. 394/02, s. 1; O. Reg. 89/03, s. 1; O. Reg. 335/03, s. 1; O. Reg. 59/04, s. 1; O. Reg. 183/04, s. 1; O. Reg. 215/04, s. 1; O. Reg. 277/04, s. 1; O. Reg. 319/04, s. 1; O. Reg. 358/04, s. 1; O. Reg. 378/04, s. 1; O. Reg. 6/05, s. 1; O. Reg. 13/05, s. 1; O. Reg. 35/05, s. 1; O. Reg. 128/05, s. 1; O. Reg. 188/05, s. 1; O. Reg. 190/05, s. 1; O. Reg. 240/05, s. 1; O. Reg. 418/05, s. 1; O. Reg. 458/05, s. 1; O. Reg. 485/05, s. 1 (1); O. Reg. 488/05, s. 1; O. Reg. 500/05, s. 1 (1); O. Reg. 545/05, s. 1; O. Reg. 54/06, ss. 1 (1); O. Reg. 203/06, s. 1; O. Reg. 458/06, s. 1 (1-3).

(1.1) Revoked:  O. Reg. 54/06, s. 1 (2).

(1.2), (1.3) Revoked:  O. Reg. 458/06, s. 1 (4).

(2) For the purposes of subsection 1 (2) of the Act,

“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession.  O. Reg. 458/06, s. 1 (4).

(3) Revoked:  O. Reg. 221/10, s. 1.

(4) Revoked:  O. Reg. 458/06, s. 1 (4).

(5) Revoked:  O. Reg. 485/05, s. 1 (2).

(6) Revoked:  O. Reg. 458/06, s. 1 (4).

2. (1) Revoked: O. Reg. 221/10, s. 2 (6).

(1.1) Revoked: O. Reg. 221/10, s. 2 (6).

(2) Revoked: O. Reg. 221/10, s. 2 (6).

(3) For the purposes of section 12.1 of the Act, a “rebate” does not include the value of a benefit that is provided in accordance with ordinary commercial terms that meet all of the following conditions:

1. The benefit is provided in the ordinary course of business in the supply chain system of interchangeable products between any of a manufacturer, a wholesaler, an operator of a pharmacy or a company that owns, operates or franchises pharmacies.

2. The value of the benefit is set out in a written agreement between any of a manufacturer, a wholesaler, an operator of a pharmacy and a company that owns, operates or franchises pharmacies.

3. The benefit relates to an ordinary commercial relationship that is any of the following:

i. A prompt payment discount.

ii. A volume discount.

iii. A distribution service fee.

4. In the case of product that is not supplied to an eligible person under the Ontario Drug Benefit Act, the total value of any benefits does not exceed 10 per cent of the value of the interchangeable products based on the number of units dispensed by a pharmacy at each product’s price, which shall not exceed the price the product may be sold at under subsection 8 (1) where that subsection applies to the product.

5. A person who receives the benefit reports to the executive officer, if required by the executive officer to do so, the net selling price of the drug products representing the price of the product less the value of the benefits received.  O. Reg. 221/10, s. 2 (5).

3. Revoked:  O. Reg. 458/06, s. 2.

4. Revoked:  O. Reg. 204/96, s. 1.

5. A person may charge more than the person’s usual and customary dispensing fee for a product that is supplied pursuant to a prescription if the person explains why a fee in excess of the usual and customary fee is being charged prior to the dispensing of the prescription and the charging of the additional fee is not an act of professional misconduct under section 1 of Ontario Regulation 681/93 made under the Pharmacy Act, 1991.  R.R.O. 1990, Reg. 935, s. 5; O. Reg. 377/94, s. 1.

6. (1) It is a condition for each strength and dosage form of a drug product to be designated as interchangeable with other products that the manufacturer of the drug product submit to the executive officer,

(a) evidence that Health Canada has approved the product for sale in Canada, a copy of the product’s drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada;

(b) a letter authorizing the executive officer to gain access to all information with respect to the product in the possession of Health Canada, the Patented Medicine Prices Review Board established under section 91 of the Patent Act (Canada), the government of any province or territory in Canada or the Canadian Agency for Drugs and Technologies in Health and authorizing the executive officer to disclose any information with respect to the product in the possession of the Ministry to Health Canada, the Patented Medicine Prices Review Board, the government of a province or territory in Canada or the Canadian Agency for Drugs and Technologies in Health;

(c) documentation disclosing the product’s master formulation;

(d) the proposed drug benefit price of the product, where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act, and a proposed manufacturer’s list price where it is not proposed that the product be so designated;

(d.1) Revoked:  O. Reg. 496/00, s. 1 (4).

(e) evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act;

(f) certification in writing that no rebate as defined in subsection 12.1 (14) of the Act has been provided to a person listed in subsection 12.1 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada;

(g) Revoked:  O. Reg. 496/00, s. 1 (5).

(h) comparative bioavailability studies on humans, comparative clinical studies on humans, or both, or other in vivo studies that will show the interchangeability of the product with the original product.

(i) Revoked:  O. Reg. 496/00, s. 1 (6).

O. Reg. 18/96, s. 1; O. Reg. 204/96, s. 2; O. Reg. 28/97, s. 2 (1, 2); O. Reg. 496/00, s. 1 (1-6); O. Reg. 337/03, s. 1 (1); O. Reg. 644/05, s. 2; O. Reg. 458/06, s. 3 (1-3); O. Reg. 321/07, s. 1 (1).

(2) If Health Canada has not approved a product monograph for a drug product, the manufacturer of the product may, instead of submitting a copy of the product monograph as required under clause (1) (a), submit to the executive officer the following information:

1. Pharmaceutical information.

2. Information with respect to the product’s clinical pharmacology.

3. Information as to the product’s indications and clinical use.

4. A list of any contra-indications, warnings or precautions in the use of the product and of possible adverse reactions to its use.

5. A list of symptoms of an overdose of the product and information as to the treatment of an overdose.

6. Information with respect to the dosage and administration of the product.

7. Information regarding the availability of dosage forms for each strength of the product marketed in Canada.  O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (7); O. Reg. 458/06, s. 3 (4).

(3) Clauses (1) (c) and (h) do not apply to the manufacturer of a drug product if the dosage form, strength, formula and manufacturing process of the product and the testing standards for both the raw materials of the product and the finished product are identical to those of the product with which it seeks to be designated as interchangeable.  O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (8).

(4) A manufacturer may satisfy the condition set out in clause (1) (h) for a strength of a drug product by submitting the evidence referred to in clause (1) (h) for another strength of the same dosage form of the drug product if that information is sufficient for the purposes of evaluating the interchangeability of both the strengths of the dosage form of the product.  O. Reg. 18/96, s. 1.

(5) Clause (1) (h) does not apply with respect to a drug product that is pharmaceutically equivalent to the original product, demonstrates the same physicochemical properties of the original product, is the same dosage form, packaging format and strength as the original product and is one of the following:

1. A parenteral aqueous solution, or a powder for reconstitution into an aqueous solution, that may be administered in an intravenous, intramuscular, subcutaneous or intrathecal fashion and that is in the same solvent and in the same concentration as the original product.

2. An oral solution, elixir, syrup or other similar solubilized form in the same concentration as the original product and which contains no ingredient that will affect the bioavailability of the active ingredient.

3. An ophthalmic, otic, nasal, rectal, vaginal or inhaled solution that is topical and aqueous.  O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (9); O. Reg. 285/15, s. 1 (1).

(5.1) For the purposes of subsection (5), if a drug product has been designated by Health Canada on or after February 15, 2005 as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable, the drug product shall be deemed to be pharmaceutically equivalent to the original product and to demonstrate the same physicochemical properties of the original product.  O. Reg. 485/05, s. 2 (1); O. Reg. 321/07, s. 1 (2).

(6) Clause (1) (c) does not apply with respect to a product that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable unless the product is described in subsection (5).  O. Reg. 485/05, s. 2 (2).

(7) Clause (1) (h) does not apply to a product that is a solid oral dosage form for systemic effect and that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable.  O. Reg. 485/05, s. 2 (2).

(7.1) Clause (1) (h) does not apply to a dermatological product that contains one or more glucocorticoids as the only active ingredient or ingredients and that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable. O. Reg. 285/15, s. 1 (2).

(7.2) Clause (1) (h) does not apply to a product with a transdermal route of administration for systemic effect that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable. O. Reg. 285/15, s. 1 (2).

(8) A strength and dosage form of a drug product that contains oxycodone as the only active ingredient and that is a long-acting product that has been formulated in a solid dosage form for oral administration shall not be designated as interchangeable unless the following conditions are met:

1. There must be evidence satisfactory to the executive officer that the drug product exhibits one or more physiochemical properties that, when compared to drugs without the property or properties, make the drug product,

i. significantly more difficult to alter, break, crush, chew, dissolve or otherwise manipulate in such a way that it could be misused, abused or put to an intended use that is different than the use for which it is prescribed, or

ii. significantly less effective and less likely to be misused, abused or put to an intended use that is different than the use for which it is prescribed, if the product is altered, broken, crushed, chewed, dissolved or otherwise manipulated.

2. The evidence referred to in paragraph 1 must be demonstrated by,

i. in vitro testing,

ii. in vivo testing,

iii. another form of testing of equivalent reliability, or

iv. a combination of any of the forms of testing mentioned in subparagraphs i to iii. O. Reg. 21/13, s. 1.

7. Where it is proposed that the strength and dosage form of a product be designated as interchangeable and it is proposed that it also be designated as a listed drug product under the Ontario Drug Benefit Act, an additional condition to be met in order for it to be designated as interchangeable is that the proposed drug benefit price must be no greater than the price permitted under that Act for the strength and dosage form of the product.  O. Reg. 221/10, s. 3.

8. (1) The following conditions must be met in order for a drug product that has been designated as interchangeable to continue to be designated as interchangeable:

1. The manufacturer of the product shall give the executive officer notice of any change made to the product, including a formulation change, and of any change in the ownership of the manufacturer.

2. The product must be authorized for sale under the Food and Drugs Act (Canada).

3. The manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product where the product is designated as a listed drug product under the Ontario Drug Benefit Act.

4. If the product is a listed drug product under the Ontario Drug Benefit Act, the manufacturer shall not sell the product at a price higher than the drug benefit price permitted under that Act whether or not the product is supplied for the purposes of that Act.

5. Revoked:  O. Reg. 221/10, s. 4 (3).

5.1, 5.2 Revoked:  O. Reg. 221/10, s. 4 (1).

6. Revoked:  O. Reg. 221/10, s. 4 (3).

7. If the drug product has not been designated as a listed drug product under the Ontario Drug Benefit Act, the manufacturer of the product shall give the executive officer notice of every change in the manufacturer’s list price for the drug product.

8. The manufacturer must not have provided a rebate as defined in subsection 12.1 (14) of the Act to a person listed in subsection 12.1 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada.

9. If required by the executive officer, the manufacturer of a product that has been designated as interchangeable shall inform the executive officer of the price that the manufacturer receives for the product, net of the value of any ordinary commercial terms.  O. Reg. 28/97, s. 3; O. Reg. 458/06, s. 5 (1-4); O. Reg. 558/06, s. 3 (1, 2); O. Reg. 321/07, s. 2 (1-4); O. Reg. 354/08, s. 2 (1-3); O. Reg. 221/10, s. 4 (1-4); O. Reg. 221/10, s. 4 (5).

(2) For greater certainty, the conditions set out in subsection (1) apply whether the designation of the product as an interchangeable product took place before, on or after July 1, 2010.  O. Reg. 458/06, s. 5 (5); O. Reg. 221/10, s. 4 (6).

(3) Revoked:  O. Reg. 221/10, s. 4 (7).

(4) Revoked:  O. Reg. 221/10, s. 4 (9).

9. (1) A product that is a private label product shall not be designated as interchangeable.  O. Reg. 221/10, s. 5.

(2) In this section,

“private label product” includes a drug product in respect of which,

(a) the manufacturer applying for the designation of the product as a listed drug product does not directly fabricate the product itself, and

(i) is not controlled by a person that directly fabricates the product, or

(ii) does not control the person that directly fabricates the product, and

(b) either,

(i) the manufacturer does not have an arm’s-length relationship with a wholesaler, an operator of a pharmacy or a company that owns, operates or franchises pharmacies, or

(ii) the product is to be supplied under a marketing arrangement associating the product with a wholesaler or one or more operators of pharmacies or companies that own, operate or franchise pharmacies.  O. Reg. 221/10, s. 5.

Schedule 1 Revoked: O. Reg. 221/10, s. 6 (3).