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Interchangeable Drug Products Formulary Amended by: 43/08
NEWFOUNDLAND
Interchangeable Drug Products Formulary (Filed
Under the authority of sections 19 and 52 of the Pharmaceutical Services Act, I make the following regulations. Dated at
Ross Wiseman REGULATIONS
Short title
1.
These regulations may be cited as the Interchangeable Drug Products Formulary Regulations, 2007. Definitions 2. In these regulations (a) "Act" means the Pharmaceutical Services Act ; (a.1) "advisory committee" means the advisory committee appointed under the authority of section 20 of the Act to advise on the contents of the formulary and other matters relating to drugs; (b) "formulary " means the drug formulary defined in paragraph 2(h) of the Act which is established by and is on file with the minister;
(b.1)
"innovator price" means the price for a drug established by the innovator as recorded by the department at the time the submission is received, minus 8.5%;
(c)
"inventory adjustment fee" means a percentage set by the minister under the authority of section 50 of the Act which may be included in the price which may be charged for a drug accepted to be listed in the formulary; (d) "minister " means the minister appointed under theExecutive Council Act to administer the Act; and (e) "ultra-generic product" means a drug manufactured and packaged for a generic manufacturer which is identical to an innovator's product in every way, including its production, except for (i) identifying markings, (ii) product labelling, (iii) the name of the manufacturer, and (iv) the product trade name. Drug formulary 3. (1) The Interchangeable Drug Products Formulary is continued and is on file with the minister. (2) A copy of the formulary may be obtained from the office of the minister. (3) The prices set out in the formulary for interchangeable drugs shall be effective for the period specified by the minister in the formulary.
(4)
A drug in injectible
formulation shall not be included in the formulary. Participating manufacturer 3.1 (1) A drug manufacturer, to be eligible to make submissions for its product to be included in the formulary, shall be approved by the minister as a participating manufacturer. (2) Where the advisory committee considers that (a) a drug manufacturer has not fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall not recommend that designation to the minister; or
(b)
a
drug manufacturer has fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall recommend that designation to the minister. (3) A drug manufacturer, to be recommended by the advisory committee as a participating manufacturer, shall (a) demonstrate that it is currently conducting business in the province; (b) have the ability to provide the drug to all retail pharmacies in the province; (c) provide a listing of drugs with pricing, sales policy, and the distribution network in the province; and (d) provide any other information required by the advisory committee. Submission requirements 3.2 (1) A participating manufacturer shall provide the following before the advisory committee will consider its submission for a drug to be included in the formulary:
(a)
a
list of the applicable Health
(b) details of the percent savings versus the innovator's product, which shall be a minimum of 25% less than the innovator price;
(c)
a
Notice
of Compliance from Health
(d) confirmation of the manufacturer's ability to supply the drug to the provincial market;
(e)
consent
from the manufacturer permitting the province to contact Health
(f) a completed request for generic drug substitution in the form prescribed by the minister; (g) a product sample for any drug contained in a device or apparatus for the purpose of drug delivery; (h) where the submission relates to an ultra-generic or cross licensed drug, confirmation of the arrangement from the company with whom the arrangement is in place; and (i) the quoted price for the drug, which shall be (i) equal or less than the best available price required by section 23 of the Act, and
(ii)
quoted
in smallest unit pricing irrespective of package size. (2) Notwithstanding paragraph (1)(b), where a submission relates to an addition to existing categories where an innovator lowers its price after the drug becomes interchangeable, a submission received after that time shall include a price for the product which is less than or equal to the current lowest price in that category. (3) Where a drug is approved for addition to an existing category under subsection (2), it shall not be included in a supplement to the formulary but shall be added to the formulary at its next publication. Review process 3.3 (1) Where a submission for inclusion of a drug in the formulary meets the requirements in section 3.2, it shall be considered by the advisory committee according to either
(a)
the
standard review process; or (b) the expert review process. (2) The standard review process shall be employed for (a) drugs with a Health Canada Declaration of Equivalence to a Canadian reference product; (b) all ultra-generic drugs; and (c) all cross-licensed drugs where the other drug is currently listed in the formulary. (3) Drugs (a) not falling within paragraphs (2)(a) to (c); or (b) which have been reviewed under the standard review process and about which the committee has a clinical concern shall
be referred by the advisory committee for expert analysis of bioequivalence, bioavailability and other applicable data before the drugs may be considered by the advisory committee under the expert review process. (4) The expert review process shall be employed for completed submissions for (a) drugs without a Health Canada Declaration of Equivalence to a Canadian reference product; or (b) any drug which has been reviewed under the standard review process about which the advisory committee has concerns and requires a further review under the expert review process.
(5)
A submission to the expert review process shall include bioequivalence and bioavailability studies relating to the drug that is the subject of the submission. (6) In addition to the submission requirements noted in section 3.2, the advisory committee shall, in assessing a drug for inclusion in the formulary, consider (a) the definition of interchangeable drug products as set out in the Act; (b) whether the drug is of consistent satisfactory quality and safety; (c) any clinical concerns raised to or by the advisory committee; and (d) those other matters which the advisory committee considers necessary in the review process. Advisory committee recommendation 3.4 (1) Where the advisory committee has approved a drug under the standard review process or the expert review process, as appropriate, the committee shall recommend to the minister that the drug be included in the formulary. (2) Where the advisory committee does not approve a drug under the standard review process or the expert review process, as appropriate, the committee shall recommend to the minister that it not be included in the formulary. Notification of change to a drug
3.5
Where a drug manufacturer makes a change to a drug listed in the formulary that requires the approval of Health
Pricing of drugs within categories
4.
(1) In accordance with section 21 of the Act, the minister may establish categories of drugs which are included in the formulary and may set the price which shall be charged for drugs within a category. (2) The price of drugs in drug categories shall be the price charged on the date specified by the minister in the formulary, or where no date is specified, as of the effective date of the formulary. Maximum price
5.
(1) In accordance with section 23 of the Act, the maximum price listed for a drug in the formulary shall not exceed the price listed for the same drug as published in the formulary to the Ontario public drug program, plus an inventory adjustment fee set by the minister. (2) A guaranteed price submitted by a manufacturer under subsection 23(1) of the Act which exceeds the price listed for that drug published in the formulary to the Ontario public drug program does not comply with subsection 23(2) of the Act and that price shall not, under the authority of subsection (1), be accepted by the minister as a price at which to list the drug in the formulary. (3) Where a guaranteed price submitted by a manufacturer is not accepted by the minister under subsection (2), for the purpose of setting the maximum price at which a drug may be listed in the formulary, the minister may substitute as the price for that drug the price listed for the drug as published in the formulary to the Ontario public drug program, plus an inventory adjustment fee. (4) Notwithstanding subsection (3), (a) a manufacturer may choose to withdraw a guaranteed price submitted to the minister where that manufacturer chooses not to proceed with an application for the inclusion of a drug in the formulary; or
(b)
the
minister may, where the guaranteed price submitted by a manufacturer exceeds the price listed for that drug as published in the formulary to the
(i) refuse to list a drug in the formulary, or (ii) in accordance with subsection 19(4) of the Act, remove a drug from the formulary. Repeal 6. The Interchangeable Drug Products Formulary Regulations, 1998, Newfoundland and Labrador Regulation 75/98, are repealed. Commencement
7.
These regulations shall come into force on
ŠEarl G. Tucker, Queen's Printer |