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Submission Requirements

Canadian Manufacturers of Self-Monitoring of Blood Glucose (SMBG) strips, lancets, and needles
New Chemical Entities and New Combination Products
Single Source Products that do not contain new chemical entities
Line Extension Products
Changes to Benefit Status of Listed Single Source Drug Products due to a new indication
Interchangeable Drug Products
Old Drug Products

Consent letter template (MS Word document)

Budget Impact Assessment (MS Word document)

Manufacturers should note that only complete submissions will be put forward for consideration by the Manitoba Drug Standards and Therapeutic Committee (MDSTC). There is no guarantee that every completed submission will be reviewed, and/or a recommendation made at the next scheduled meeting of the MDSTC.

Please note that Pre-NOC submissions cannot be accepted at this time.

Manitoba Health is reserving the right to request the French version of the official Product Monograph for selected products.

Only two (2) copies of a submission for a drug product are required.

All submissions should be sent to the attention of:

Drug Submissions Coordinator
Manitoba Health, Provincial Drug Programs
1014 - 300 Carlton Street
Winnipeg, Manitoba R3B 3M9

To ensure continued listing of drug products, manufacturers are required to notify the Secretary of the MDSTC of any significant change made to listed drug products such as changes in NOC, DIN, product name, manufacturer or distributor, product monograph, price, manufacturing specifications and changes in excipients that can cause sensitivity reactions (e.g. tartrazine, lactose, gluten) or any change that could potentially affect the bioavailability or bioequivalence of a drug product.

A significant change is also considered to be a new indication for a single source drug product listed as an unrestricted benefit: in this case, in addition to the new NOC and revised product monograph, information regarding clinical evidence and financial impact for the new indication will be required.

All inquiries regarding submission requirements should be directed to:

Administrative Assistant, MDSTC
Manitoba Health, Provincial Drug Programs
300 Carlton Street
Winnipeg, Manitoba R3B 3M9
Phone: (204) 786 7233
Fax: (204) 942 2030

Canadian Manufacturers of Self-Monitoring of Blood Glucose (SMBG) strips, lancets, and needles

New Submission Requirements for Canadian Manufacturers of Self-Monitoring of Blood Glucose (SMBG) strips, lancets, and needles

All Canadian manufacturers (hereinafter individually referred to as “the company”) of SMBG strips, lancets, and needles must provide the following in writing to:

Provincial Drug Programs
Manitoba Health and Healthy Living (MHHL)
1014 - 300 Carlton Street Winnipeg MB R3B 3M9
Attention: Drug Submissions Coordinator

Licensing, pricing, etc.

Device specifications for the SMBG strip, lancet or needle (hereinafter referred to as the “Medical Device”) that the Company is requesting the Minister of Health to specify as a “drug benefit” under The Prescription Drugs Cost Assistance Act (Manitoba) and listed in the Manitoba Drug Benefits and Interchangeability Formulary ;
A copy of the license or authorization issued to the Company by the Therapeutics Products Directorate, Medical Devices Bureau, Health Canada for the Medical Device under the Medical Devices Regulations (SOR/98-282) of the Food and Drugs Act (Canada);
A copy of the Medical Device label, as approved by the Health Products and Food Branch (HPFB);
A copy of all promotional materials and package insert(s);
If the Medical Device is an SMBG strip: clinical evaluations that the Company has obtained to show the exactness and precision of the results from using the Medical Device;
If the Medical Device is an SMBG strip: describe how the Company will educate health care professionals, including physicians and pharmacists in the Province of Manitoba on use of the Medical Device and indicate whether the Company has any plan to ensure that patients are appropriately trained on how to use the Medical Device and to interpret their results;
The actual cost by single unit (e.g. per strip, etc) that reflects either 1) the direct source cost for the product from the manufacturer or 2), if the product is not available directly from the manufacturer, the distribution channel and the source cost that includes all distribution costs at which the Company will sell Medical Device in the Province of Manitoba over the next three (3) years
A comparison of the submitted price versus the current prices in any other Provincial/Territorial jurisdiction in which the Medical Device is currently sold by the Company;
A yearly forecast of Government of Manitoba total expenditures under Manitoba Pharmacare and all other provincially funded drug programs over three (3) years for the Medical Device. Each yearly forecast would include
1. the total projected cost to the Government of Manitoba;
2. the net expenditure impact (whether cost additive or cost saving) to the Government of Manitoba;
3. an estimate of the Company’s market share for the Medical Device in the Province of Manitoba; and
4. any key forecasting assumptions.
Analysis of the price-benefit that the Medical Device will offer to the Province of Manitoba over other Medical Devices that are currently specified as a drug benefit under The Prescription Drugs Cost Assistance Act (Manitoba) and listed in the Manitoba Drug Benefits and Interchangeability Formulary.

A declaration (in form and content acceptable to MHHL and signed by a senior
official of the Company) attesting to the truth of the following facts:

the date that the Medical Device will be available for sale in the Province of Manitoba and the period of time that it will continue to be available;
that the Company will comply with the Medical Device TechnologyCompanies (MEDAC) Code of Conduct, if applicable to the Medical Device;
that the Medical Device will be available to all pharmacy vendors in the Province of Manitoba for a minimum of one (1) year ; and
that the Company is not aware of any patent or trademark infringement claims or actions, or any threatened claims, actions or proceedings, relating to the Medical Device that may prevent the Medical Device from being sold in the Province of Manitoba.

Consent

The Company must provide its written consent (i.e. on Company letterhead signed by an authorized senior official of the Company) consenting to MHHL having unrestricted communications regarding the Medical Device with Federal/Provincial/Territorial (F/P/T) drug plans, F/P/T governments, including their agencies and departments, F/P/T health authorities, including regional health authorities, Health Canada, the Canadian Agency for Drugs and Technologies in Health, and the Patented Medicine Prices Review Board, and for all of these organizations to communicate with MHHL.

New Chemical Entities and New Combination Products

Manitoba is participating in the Common Drug Review (CDR) process. As a consequence, submissions for new chemical entities and new combination products should be made directly to the CDR Directorate in accordance to the CDR Submission Guidelines as posted on the Canadian Agency for Drugs and Technologies in Health (CADTH) website.

The Budget Impact Analysis for Manitoba Health should be prepared in accordance to the template supplied here: 2003 Budget Impact Analysis.

Single Source Products that do not contain new chemical entities

Manitoba Health will accept submissions of single source products that do not contain new chemical entities and that will not fall under the jurisdiction of the CDR process; however, the same submission requirements as per CDR guidelines will apply to this category of products.

Line Extension Products

The following submission requirements pertain to new strengths and formulations or re-formulations of drug products that are currently listed in the Manitoba Drug Benefits and Interchangeability Formulary.

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Pricing Information
Ability to Supply Letter
Patent(s) expiry date(s)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB.
A copy of the letter can be found here.
Justification of the need for the Line Extension
Copy of Comprehensive Summary ('Clinical Studies' section only) or other document accepted by Health Canada and copies of critical studies that address key clinical issues relevant to the new strength, formulation or re-formulation) or Evidence of formulation proportionality or Bioequivalence data; and evidence of a similar dissolution profile
Copy of completed and approved Certified Product Information Document (CPID)
Bibliography (medical literature database search of the last two years prior to submission)
Economic Information (i.e. a Budget Impact Analysis for the Manitoba Drug Benefits and Interchangeability Formulary).

Changes to Benefit Status of listed Single Source Drug Products due to a new indication

The following submission requirements pertain to single source drug products currently listed in Part 2 or Part 3 of the Manitoba Drug Benefits and Interchangeability Formulary that have received a new indication from the Therapeutic Product Directorate (TPD) and where the manufacturer wishes to request expansion of the coverage criteria or change in benefit status due to the new indication.

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Pricing Information
Ability to Supply Letter
Patent(s) expiry date(s)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB).
A copy of the letter can be found here.
Justification for the Expanded Coverage Criteria or Change in Benefit Status
Copy of Comprehensive Summary ('Clinical Studies' section only) or other document accepted by Health Canada and copies of critical studies that address key clinical issues relevant to the new indication)
Copy of completed and approved Certified Product Information Document (CPID)
Bibliography (medical literature database search of the last two years prior to submission)
Economic Information (i.e. a pharmacoeconomic evaluation in accordance with the CADTH "Guidelines for Economic Evaluation of Pharmaceuticals: Canada" 2nd edition, November 1997; and a Budget Impact Analysis for the Manitoba Drug Benefits and Interchangeability Formulary).

Interchangeable Drug Products

The following submission requirements pertain to multisource products submitted for listing in an interchangeable grouping in the Manitoba Drug Benefits and Interchangeability Formulary

A. Drug products in solid oral dosage forms reviewed by the TPD according to the guidelines "Conduct and Analysis of Bioavailability and Bioequivalence studies - Part A and B"

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects either 1) the direct source cost for the product from the manufacturer or 2), if the product is not available directly from the manufacturer, the distribution channel and the source cost that includes all distribution costs
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Current Patent Status (letter from the manufacturer stating that there are no patent infringements associated with the submission of the product)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Copy of completed and approved Certified Product Information Document (CPID)

As the Minister will be relying on the information submitted in making a decision, any deviation by the manufacturer from the required plans and declarations or the provision of inaccurate information will be cause for removal of a product from the Manitoba Drug Interchangeability Formulary Regulation and the Specified Drugs Regulation (as applicable) at the Minister’s discretion.

B. Drug products in solid oral dosage forms reviewed by the TPD according to the guidelines "Conduct and Analysis of Bioavailability and Bioequivalence studies - Report C"

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects the source cost for the product if it not available directly from the manufacturer
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Current Patent Status (letter from the manufacturer stating that there are no patent infringements associated with the submission of the product)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Copy of completed and approved Certified Product Information Document (CPID)
Executive summary of comparative bioavailability studies with the reference drug product, including tables of calculated pharmacokinetic parameters, ratios of geometric means for relevant PK parameters and relative 90% CI (or 95% CI where appropriate) for the measured and for the potency corrected data, mean plasma concentrations vs. time curves (linear and log-transformed) or
Executive summary of comparative pharmacodynamic studies.

C. Drug products not in solid oral dosage forms

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects the source cost for the product if it not available directly from the manufacturer
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Current Patent Status (letter from the manufacturer stating that there are no patent infringements associated with the submission of the product)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Copy of completed and approved Certified Product Information Document (CPID)
Executive summary of comparative bioavailability studies with the reference drug product, including tables of calculated pharmacokinetic parameters, ratios of geometric means for relevant PK parameters and relative 90% CI (or 95% CI where appropriate) for the measured and for the potency corrected data, mean plasma concentrations vs. time curves (linear and log-transformed) or
Surrogate comparisons with the reference drug product (i.e. in vivo or in vitro test methods or a pharmacodynamic or therapeutic equivalence study)

D. Drug products that are pseudo-generics

Copy of NOC
Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects the source cost for the product if it not available directly from the manufacturer
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Current Patent Status (letter from the manufacturer stating that there are no patent infringements associated with the submission of the product)
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Copy of completed and approved Certified Product Information Document (CPID)
Letters from both the manufacturer of the submitted product and the manufacturer of the innovator brand (or a currently listed product in the same interchangeable category) confirming that the two products are identical (identical master formula and manufacturing and quality control specifications).

Old Drug Products

The following submission requirements pertain to products submitted for listing in an interchangeable grouping in the Manitoba Drug Benefits and Interchangeability Formulary where the active ingredient is designated as an “Old Drug” by the TPD and the drug product is approved on the basis of a DIN application (i.e. an NOC is not issued)

A. Drug Products in solid oral dosage forms

Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph or Prescribing Information
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects either 1) the direct source cost for the product from the manufacturer or 2), if the product is not available directly from the manufacturer, the distribution channel and the source cost that includes all distribution costs
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Executive summary of comparative bioavailability study or pharmacodynamic study or studies conducted in accordance with the TPD guidelines “Conduct and Analysis of Bioavailability and Bioequivalence studies – Part A and B and Report C”
Copy of completed and approved Certified Product Information Document (CPID)

B. Drug products not in solid oral dosage form

Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph or Prescribing Information
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects either 1) the direct source cost for the product from the manufacturer or 2), if the product is not available directly from the manufacturer, the distribution channel and the source cost that includes all distribution costs
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Executive summary of comparative bioavailability study or pharmacodynamic study or studies conducted in accordance with the TPD guidelines “Conduct and Analysis of Bioavailability and Bioequivalence studies – Part A and B and Report C” or
Surrogate comparisons with the reference drug product (i.e. in vivo or in vitro test methods or a pharmacodynamic or therapeutic equivalence study)
Copy of completed and approved Certified Product Information Document (CPID)

C. Products that are pseudo-generics

Copy of completed Drug Identification Number (DIN) notification form
Copy of approved Product Monograph or Prescribing Information
Indication of the actual cost by single unit (e.g. per milliliter, per tablet, etc) that reflects either 1) the direct source cost for the product from the manufacturer or 2), if the product is not available directly from the manufacturer, the distribution channel and the source cost that includes all distribution costs
Declaration of the period of time that the manufacturer will retain the price submitted as the maximum price; if the manufacturer does not plan to retain the price submitted over the next 365 days, an outline of any proposed price increases for the submitted product, by strength if applicable, over the next 365 days
Analysis of the price-benefit that the submitted product offers over other products within the same interchangeable grouping
Declaration that, at the time of the submission, the price included in the submission is not higher than, and is at least equal to, the price of the submitted product in any other Provincial/Territorial jurisdiction [or if the price is higher, a price comparison and explanation as to the reason that the offered price is higher]
Plan of how the manufacturer will minimize and mitigate the impact from and compensate pharmacy providers if the manufacturer is unable to supply the submitted product, e.g. advance notice by the manufacturer to Manitoba Health and pharmacy providers of the inability to supply and any compensation/reimbursement to be provided to pharmacy providers with respect to additional costs incurred as a result of the inability to supply
Consent letter (letter authorizing unrestricted communication regarding the drug product between and amongst Manitoba Health and F/P/T drug plans, F/P/T governments including their agencies and departments, F/P/T health authorities including regional health authorities, Health Canada, CADTH and the PMPRB). A copy of the letter can be found here.
Copy of completed and approved Certified Product Information Document (CPID)
Letters from both the manufacturer of the submitted product and the manufacturer of the innovator brand (or a currently listed product in the same interchangeable category) confirming that the two products are identical (identical master formula and manufacturing and quality control specifications).

For more information please contact:

Manitoba Health - Provincial Drug Programs
300 Carlton Street
Winnipeg MB R3B 3M9

In Winnipeg, call (204) 786-7141
Outside of Winnipeg 1-800-297-8099 (toll-free)