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St. John's, Newfoundland and Labrador, Canada

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Newfoundland and Labrador
Regulation 2007


NEWFOUNDLAND AND LABRADOR REGULATION 126/07

NEWFOUNDLAND AND LABRADOR
REGULATION 125/07

Interchangeable Drug Products Formulary
Regulations, 2007
under the
Pharmaceutical Services Act

(Filed December 20, 2007)

Under the authority of sections 19 and 52 of the Pharmaceutical Services Act, I make the following regulations.

Dated at St. John’s, December 20, 2007.

Ross Wiseman
Minister of Health and Community Services

REGULATIONS

Analysis


        1.   Short title

        2.   Definitions

        3.   Drug formulary

        4.   Pricing of drugs within categories

        5.   Maximum price

        6.   Repeal

        7.   Commencement


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;

             (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;

             (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; and

             (d)  "minister" means the minister appointed under the Executive Council Act to administer the Act.

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.

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 Ontario public drug program,

                      (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 January 1, 2008.