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NEWFOUNDLAND

AND

LABRADOR

REGULATION 23/12

Interchangeable Drug Products Formulary

Regulations, 2012

under the

Pharmaceutical Services Act

Amended by:

41/13

65/13

10/14

NEWFOUNDLAND

AND

LABRADOR

REGULATION 23/12

Interchangeable Drug Products Formulary

Regulations, 2012

under the

Pharmaceutical Services Act

(Filed March 30, 2012)

Under the authority of sections 19 and 52 of the Pharmaceutical Services Act,

I make the following regulations.

Dated at St. Johns

, March 30, 2012.

Bruce Cooper

Deputy Minister of Health and Community Services

REGULATIONS

Analysis

Short title

Definitions

Drug formulary

Submission requirements

Maximum price for interchangeable products

Exemption

Pricing of drugs within categories

Rep. by 41/13 s5

Review process

Advisory committee recommendation

Notification of change to a drug

Repeal

Commencement

Short title

These regulations may be cited as the Interchangeable Drug Products Formulary Regulations, 2012.

23/12 s1

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Definitions

In these regulations

(a)

"Act" means the Pharmaceutical Services Act

(b)

"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;

(c)

"brand price" means the price for a brand name drug established by the manufacturer as of April 16, 2012;

(c.1)

"cross licensed drug" means a drug that is the subject of an agreement between 2 companies where one company supplies a drug product to another company for sale under the second company's name;

(d)

"formulary" means the drug formulary defined in paragraph 2(

h) of the Act which is established by and is on file with the minister;

(e)

"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

(f)

"ultra-generic product" means a drug manufactured and packaged for a generic manufacturer which is identical to a brand manufacturer'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.

23/12 s2 ; 41/13 s1 ; 10/14 s1

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Drug formulary

(1)The Interchangeable Drug Products Formulary is continued and is on file with the minister.

(2) A copy of the formulary is available on the departmental website and may also 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 except where the price is governed by an agreement made by the minister with respect to pricing of generic drugs.

23/12 s3 ; 41/13 s2

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Submission requirements

An applicant shall provide the following before the advisory committee will consider its submission for a drug to be included in the formulary:

(a)

[Rep. by 10/14 s2]

(

b) confirmation that the drug will be sold at the maximum price established under

section 5, or where the percentage of savings is greater than required under that section, details of those savings and a guarantee of that price for the time period required by the minister;

(

c) the quoted price for the drug, which shall be quoted in smallest unit pricing irrespective of package size;

(

d) where a Notice of Compliance from Health Canada

(

i) has been issued, a copy of that notice, or

(ii)

has not been issued, a copy of the Drug Notification form;

(

e) confirmation satisfactory to the minister or the advisory committee that the applicant is able to supply the drug to meet the needs of the market for that drug throughout the entire province;

(

f) consent permitting the province to contact Health Canada

and other federal, provincial or territorial departments or agencies for additional information where necessary;

(

g) a completed request for generic drug substitution in the form prescribed by the minister;

(

h) a product sample for any drug contained in a device or apparatus for the purpose of drug delivery;

(

i) where the submission relates to an ultra-generic or cross licensed drug, confirmation of the business arrangement from the company with whom the business arrangement is in place; and

(

j) where a drug has not been launched at the time of the application, the anticipated launch date.

23/12 s4 ; 10/14 s2

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Maximum price for interchangeable products

(1)The price for a product listed in the formulary shall not exceed the maximum price as set out in the following table as of the applicable dates:

Date

Maximum Price

From April 1, 2013 to June 30, 2013

35% of the brand price

From July 1, 2013 onward

25% of the brand price

(2) Where, at the coming into force of this section, a drug is listed on the formulary which

(

a) is a sole source product; or

(

b) is a generic drug for which the equivalent brand product has been discontinued,

the manufacturer of that drug may, notwithstanding subsection (1), maintain the price listed in the formulary at the coming into force of this

section until July 1, 2012, but after that date shall comply with the requirements of subsection (1) with respect to the maximum price of that drug unless an exemption is allowed under

section 6.

(3) Notwithstanding another provision of this section, where a drug listed in the formulary is a drug included in the Pan-Canadian Competitive Value Price Initiative for Generic Drugs, the maximum percentage of brand price for that drug shall not exceed the percentage established by the initiative.

23/12 s5 ; 41/13 s3 ; 65/13 s1

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Exemption

(1)Notwithstanding subsection 5(1), an applicant may apply to the minister to have a drug included in the formulary which does not meet the

pricing requirements of that subsection, and the minister may allow that exemption where

(

a) the brand name product has been discontinued; or

(

b) in the opinion of the minister, the applicant has incurred extraordinary production, manufacturing or development costs for the drug, as demonstrable to the satisfaction of the minister.

(2) The minister may request and the applicant shall provide the information the minister considers necessary for the purpose of evaluating an application for an exemption under subsection (2).

(3) The minister may impose conditions on an exemption granted under this section, and may limit the time period for which the exemption is granted.

(4) Where an application for an exemption has been approved under subsection (1), the advisory committee may consider that drug for inclusion in the formulary provided that all other requirements of

section 4 are met.

(5) This

section does not apply to drugs which are included on the Pan Canadian Competitive Value Price Initiative for Generic Drugs.

23/12 s6 ; 41/13 s4

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Pricing of drugs within categories

(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.

(3) The price set under subsection (1) may include an inventory adjustment fee set by the minister.

23/12 s7

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Rep. by 41/13 s5

[Rep. by 41/13 s5]

41/13 s5

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Review processes

(1)Where a drug meets the submission requirements of

section 4 it shall be reviewed for inclusion in the formulary in accordance with subsection (2), (3) or (4) by

(

a) the minister, in an administrative review; or

(

b) the advisory committee, in a standard review process or an expert review process.

(2) The following drugs shall be subject to an administrative review process:

(

a) an ultra-generic drug;

(

b) a cross licensed drug where the other drug is currently listed in the formulary;

(

c) a drug with a Canadian reference product to a generic drug currently listed in the formulary;

(

d) a drug with a Canadian reference product to a generic drug that had not previously been submitted or reviewed for inclusion in the formulary; and

(

e) a drug with a Canadian reference product to a brand name product.

(3) The following drugs shall be subject to a standard review process:

(

a) a drug with a Canadian reference product to a generic drug that has either been rejected from inclusion in the formulary or removed from the formulary for any reason;

(

b) a drug with a Canadian reference product to a non-Canadian reference product; and

(

c) notwithstanding subsection (2), a drug which the minister determines should be reviewed in accordance with a standard review process.

(4) The following drugs shall be subject to an expert review process:

(

a) a drug without a Canadian reference product which is not

(

i) an ultra-generic drug, or

(ii)

a cross licensed drug

with another drug currently listed on the formulary;

(

b) a drug referred for an expert review process as a result of concerns identified in the standard review process; and

(

c) notwithstanding subsection (2) or subsection (3), a drug which the minister determines should be reviewed in accordance with an 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, and any other information that the advisory committee may require to assess the drug.

(6) In addition to the submission requirements in

section 4, when assessing a drug for inclusion in the formulary the minister or the advisory committee, shall consider the following:

(

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 minister or advisory committee considers necessary in the review process.

10/14 s3

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Advisory committee recommendation

(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.

23/12 s10

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Notification of change to a drug

Where a manufacturer makes a change to a drug listed in the formulary that requires the approval of Health Canada

, the manufacturer, immediately after receipt of the approval of Health Canada

, shall notify the advisory committee of the change.

23/12 s11

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Repeal

The Interchangeable Drug Products Formulary Regulations, 2007,

Newfoundland and Labrador Regulation 125/07, are repealed.

23/12 s12

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Commencement

These regulations come into force on April 16, 2012.

23/12 s13

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