THE NEWFOUNDLAND AND LABRADOR GAZETTE EXTRAORDINARY

Part II PUBLISHED BY AUTHORITY ST. JOHN'S, MONDAY, FEBRUARY 10, 2014 NEWFOUNDLAND AND LABRADOR REGULATION NLR 10/14

Extraordinary Gazette February 10, 2014 3 NEWFOUNDLAND AND LABRADOR REGULATION 10/14 Interchangeable Drug Products Formulary Regulations, 2012 (Amendment) under the Pharmaceutical Services Act (Filed February 10, 2014) Under the authority of sections 19 and 52 of the Pharmaceutical Services Act, I make the following regulations. Dated at St. John’s, February 10, 2014. Susan Sullivan Minister of Health and Community Services REGULATIONS Analysis 1. S.2 Amdt.

Definitions 2. S.4 Amdt. Submission requirements 3. S.9 R&S Review processes

Section 2 of the Interchangeable Drug Products Formulary Regulations, 2012 is amended by adding immediately after paragraph (

c) the following: (c.1) "cross licensed drug" means a drug that is the subject of an agreement between 2 comp anies where one company supplies a drug product to another company for sale under the second company's name; NLR 23/12 as amended

Interchangeable Drug Products Formulary Regulations, 2012 (Amendment) 10/14 Extraordinary Gazette February 10, 2014 4 2.

(1) Paragraph 4(

a) of the regulations is repealed.

(2) Paragraph 4(

e) of the regulations is repealed and the following substituted: (

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;

Section 9 of the regulations is repealed and the following substituted: 9.

(1) Where a drug meets the subm ission 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: Review processes

Interchangeable Drug Products Formulary Regulations, 2012 (Amendment) 10/14 Extraordinary Gazette February 10, 2014 5 (

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 refe rence 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;

Interchangeable Drug Products Formulary Regulations, 2012 (Amendment) 10/14 Extraordinary Gazette February 10, 2014 6 (

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. ©Queen's Printer

7 ST. JOHN'S, MONDAY, FEBRUARY 10, 2014 Extraordinary Gazette Index Title of Act and Subordinate Legislation CNLR or XNL Gazette made thereunder NL Reg. Amendment Date & Page No. Pharmaceutical Services Act Interchangeable Drug NLR 10/14 Am ends Feb 10/14 p. 3 Products Formulary NLR 23/12 Regulations, 2012 S.2 Amdt. (Amdt.) S.4 Amdt. S.9 R&S