Submission Requirements

As the Minister of Health or the Minister's delegate will be relying on the information submitted in making a decision, any deviation by the Company from the required plans and declarations or the provision of inaccurate information will be cause for removal of a Product from the Manitoba Drug Benefits and Interchangeability Formulary and/or removal of a Product's Exception Drug Status (EDS) benefit status under the Prescription Drugs Cost Assistance Act (PDCAA) (as applicable) at the Minister's or the Minister's delegate's discretion.

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 one (1) electronic copy of a submission for a drug product is required.

All submissions should be emailed to the attention of:

MDSTC Coordinator
Manitoba Health
Non-Insured Benefits Branch
NIBOperations@gov.mb.ca

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 new indication for a single source drug product listed as an unrestricted benefit is also considered to be a significant change. 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:

MDSTC Coordinator
Manitoba Health
Non-Insured Benefits Branch
1014 - 300 Carlton Street
Winnipeg, Manitoba R3B 3M9
Phone: 204-786-7233
Fax: 204-946-5070

Below are submission cut-off dates for Manitoba’s Bulletin Editions. These dates are tentative and may change at the sole discretion of the Ministry.

Submission Cut Off*
June 1, 2024
August 1, 2024
October 1, 2024
December 1, 2024

*If internal timelines allow, complete drug submissions received after deadline may be considered for listing in a Bulletin

The following specific submission requirements apply:

A. All Generic Drug Products, including pseudo-generics 

  1. Copy of NOC. (For 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, no NOC required).
  2. Copy of completed Drug Identification Number (DIN) notification form.
  3. Copy of approved Product Monograph.
  4. Indication of the actual cost by single unit (e.g. per millilitre, per tablet, etc.) that reflects either: 1) the direct source cost for the Product from the Company or 2) if the Product is not available directly from the Company, the distribution channel and the source cost that includes all distribution costs.
  5. Current Patent Status (letter from the Company stating that there are no patent infringements associated with the submission of the Product).
  6. Declaration (in form and content acceptable to Manitoba Health (MHSC) and signed by a senior official of the Company) attesting that the product shall be available in sufficient amounts for delivery to pharmacies in Manitoba commencing on the date of listing.
  7. 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). View the letter here.MS-Word document
  8. Copy of completed and approved Certified Product Information Document (CPID).
  9. For pseudo-generics, letters from both the Company of the submitted Product and the Company 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).

B. Old Drug Products

The above submission requirements also apply 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).

C. Self-Monitoring of Blood Glucose (SMBG) strips, lancets, and needles

  1. 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 or the Minister’s delegate to specify as a “drug benefit” under The Prescription Drugs Cost Assistance Act (Manitoba) and listed in the Manitoba Drug Benefits and Interchangeability Formulary;
  2. 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);
  3. The actual cost by single unit (e.g. per strip, etc.) that reflects either 1) the direct source cost for the Product from the Company or 2), if the Product is not available directly from the Company, the distribution channel and the source cost that includes all distribution costs;
  4. 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). View the letter here.MS-Word document
  5. A declaration (in form and content acceptable to Manitoba Health (MHSC) and signed by a senior official of the Company) attesting to the truth of the following facts:
    1. at the time of the submission, the price of the Medical Device in Manitoba is not higher than, and is at least equal to, the price of the same Medical Device in any other Provincial/Territorial jurisdiction; and
    2. that the Medical Device will be available to all pharmacy vendors in the Province of Manitoba for a minimum of one (1) year.

D. Single Source Products

All product submissions may be subject to review by the pan-Canadian Pharmaceutical Alliance.

Manitoba participates in the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes. As a consequence, submissions for new chemical entities and new combination products should be made directly to the CDR/pCODR Directorate in accordance with the CDR/pCODR Submission Guidelines as posted on the Canadian Agency for Drugs and Technologies in Health (CADTH) website. 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/pCODR process; however, the same submission requirements as per CDR/pCODR guidelines will apply to this category of products.

The Budget Impact Analysis for Manitoba Health should be prepared in accordance with the template supplied here: Budget Impact Analysis.MS-Word document

E. Line Extension Products

All product submissions may be subject to review by the pan-Canadian Pharmaceutical Alliance.

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.

  1. Executive Summary
  2. Copy of NOC
  3. Copy of completed Drug Identification Number (DIN) notification form
  4. Copy of approved Product Monograph
  5. Pricing Information
  6. Ability to Supply Letter
  7. Patent(s) expiry date(s)
  8. 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.) View the letter here.MS-Word document
  9. Justification of the need for the Line Extension
  10. 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
  11. Copy of completed and approved Certified Product Information Document (CPID)
  12. Bibliography (medical literature database search of the last two years prior to submission)
  13. Economic Information (i.e. a Budget Impact Analysis).

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

All Product submissions may be subject to review by the pan-Canadian Pharmaceutical Alliance.

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 Company wishes to request expansion of the coverage criteria or change in benefit status due to the new indication.

  1. Executive Summary
  2. Copy of NOC
  3. Copy of completed Drug Identification Number (DIN) notification form
  4. Copy of approved Product Monograph
  5. Pricing Information
  6. Ability to Supply Letter
  7. Patent(s) expiry date(s)
  8. 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). View the letter here.MS-Word document
  9. Justification for the Expanded Coverage Criteria or Change in Benefit Status
  10. 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
  11. Copy of completed and approved Certified Product Information Document (CPID)
  12. Bibliography (medical literature database search of the last two years prior to submission)
  13. Economic Information (i.e. a Budget Impact Analysis)

Ongoing Listing Requirements

As the Minister of Health, Seniors and Long-Term Care or the Minister's delegate will be relying on the information submitted in making a decision, any deviation by the Company from the required plans and declarations or the provision of inaccurate information will be cause for removal of a Product from the Manitoba Drug Benefits and Interchangeability Formulary and/or removal of a Product's Exception Drug Status (EDS) benefit status under the Prescription Drugs Cost Assistance Act (PDCAA) (as applicable) at the Minister's or the Minister's delegate's discretion.

The following specific requirements apply to all products and are a requirement of continued listing of any drug product or medical supplies (the "Product") on the Manitoba Drug Benefits and Interchangeability Formulary and/or with an EDS benefit status under the PDCAA:

  1. If the Company is aware of a Shortage or possible Shortage of any Product, the company must:
    1. immediately notify Manitoba Health, Seniors and Long-Term Care (MHSLC) in writing if the Company is unable, for any reason, to supply the Product for more than 20 consecutive days in a quantity that is sufficient to meet the expected patient volumes throughout the Province of Manitoba; and
    2. as required, comply with sections C.01.014.8 to C.01.014.12 of the Food and Drug Regulations related to mandatory reporting of drug shortages.
  2. For Products subject to the Patent Act (Canada) and any regulations under that Act, including those pertaining to patented medicines, increases to the ex-factory list price must comply with all of the following requirements:
    1. price increases may occur no more often than annually provided that:
      1. where applicable, the increase in the price of the Product is allowed by the Patented Medicine Prices Review Board; and
      2. where applicable, the price increase is consistent with the terms specified in the executed pan-Canadian Pharmaceutical Alliance Letter of Intent (LOI) respecting the Product; and
      3. the same price increase is or has been submitted to every other provincial or territorial jurisdiction or formulary in Canada and assessed in accordance with the price increase guidelines in those jurisdictions. If a price increase has not been submitted to every jurisdiction, the Company will provide to MHSLC, for MHSLC's consideration, a written statement that outlines those jurisdictions where the same price increase will not or has not been submitted.
    2. price increases may only occur annually effective April 1st or such alternate date specified by the Minister of Health, Seniors and Long-Term Care or the Minister's delegate;
    3. the Company must submit, as applicable, either a completed pan-Canadian Pharmaceutical Alliance (pCPA) Generics Price Change Request Form to pCPA or a Manitoba Price Increase Request Form to MHSLC by December 31st of the year prior to which the price increase is requested to come into effect;
    4. the Company may not request a price increase unless the Product has been (or will be) listed as a benefit for a minimum of 365 consecutive days as of the effective date of the requested price increase;
    5. the price increase must be approved in advance by the Minister of Health, Seniors and Long-Term Care or the Minister's delegate; and
    6. a Product is not eligible for a price increase:
      1. if the Patented Medicine Prices Review Board has commenced an investigation or review into the price of a patented drug Product or such an investigation or review is pending; or
      2. if an order issued under the Patented Medicines Regulations has been issued by the Patented Medicine Price Review Board with respect to the Product and until the time period for an appeal of such order has expired, or where such order has been appealed, until after the final disposition of the appeal and any subsequent appeals.
  3. For products that are not subject to the Patent Act (Canada) or regulations under that Act, including those pertaining to patented medicines, increases to the ex-factory list price must comply with all of the following requirements:
    1. price increases may occur no more often than annually provided that:
      1. where applicable, the price increase is consistent with the terms of any executed agreement with the pan-Canadian Pharmaceutical Alliance or any other pricing commitments respecting the Product; and
      2. the same increase is or has been submitted to every other provincial or territorial jurisdiction or formulary in Canada and assessed in accordance with the price increase guidelines in those jurisdictions. If a price increase has not been submitted to every jurisdiction, the Company will provide to MHSLC, for MHSLC's consideration, a written statement that outlines those jurisdictions where the same price increase will not or has not been submitted.
    2. price increases may only occur annually effective April 1st or such alternate date specified by the Minister of Health, Seniors and Long-Term Care or the Minister's delegate;
    3. the Company must submit, as applicable, either a completed pan-Canadian Pharmaceutical Alliance (pCPA) Generics Price Change Request Form to pCPA or a Manitoba Price Increase Request Form to MHSLC by December 31st of the year prior to which the price increase is requested to come into effect;
    4. the Company may not request a price increase unless the Product has been (or will be) listed as a benefit for a minimum of 365 consecutive days as of the effective date of the requested price increase; and
    5. the price increase must be approved in advance by the Minister of Health, Seniors and Long-Term Care or the Minister's delegate;
  4. A Patient Access Program includes a compassionate drug program and means a program under which the Company provides any Manitoban with financial assistance, whether directly or indirectly, so as to enable him or her to purchase the Product at no cost or reduced cost, regardless that such person may be eligible for coverage under Manitoba Pharmacare or under any other provincial drug programs established from time to time, including without limitation the Palliative Care Drug Access Program, the Deductible Instalment Payment Program for Pharmacare and various ancillary programs (collectively referred to as the "Other Drug Programs").

    The Company:
    1. must not initiate any new Patient Access Program in the Province of Manitoba except with the prior written approval of the Minister of Health, Seniors and Long-Term Care or the Minister's delegate:
      1. where the Product is:
        1. classified under the Anatomical Therapeutic Chemical (ATC) classifications: L - Antineoplastic and Immunomodulating Agents; or
        2. for the treatment of a disease affecting fewer than 1 in 2000 Canadians; or
        3. designated on the "List of Designated High Cost Drugs"; and
      2. the Patient Access Program provides or intends to provide assistance to clients with clinical criteria that are considered eligible benefits under Manitoba Pharmacare or the Other Drug Programs;
    2. must adhere to all applicable laws including, without limitation, The Personal Health Information Act (PHIA) when administering any Patient Access Program for Manitobans;
    3. upon request of MHSLC, must provide MHSLC with:
      1. information relating to any Patient Access Program pertaining to the Product that the Company offers or makes available to Manitobans, including but not limited to aggregate patient data (non-identifiable) enrolled in the Patient Access Program, information and correspondence (such as forms, brochures, letters, consent forms, etc.) that are provided to patients and clinicians, and
      2. personal information if such disclosure is specifically requested by MHSLC and is for the purposes of delivering, monitoring, auditing and maintaining the Patient Access Program in the Province of Manitoba;
    4. must immediately notify MHSLC and all enrolled patients in a Patient Access Program if the Company makes or plans to make any changes to a program that impacts the level of assistance provided to any Manitoban; and
    5. unless otherwise agreed by MHSLC in advance in writing, must not, and shall ensure any subsidiary of the Company or any other person or organization on behalf of the Company or any subsidiary of the Company does not, offer or make a statement claiming that Company-driven changes to the program are due to actions arising from the pCPA or the Government of Manitoba.
  1. Where a Product is considered an eligible benefit under Manitoba Pharmacare or the Other Drug Programs, the Company:
    1. is responsible for establishing, maintaining and funding drug administration (infusion) services for the Product at mutually agreed upon locations;
    2. must work with MHSLC to adequately address unmet infusion service requirements or new service demands and other related service issues in a timely manner;
    3. is responsible for all costs related to the administration of infusions of the Product including, but not limited to, nursing and physician support and medical supplies, and must reimburse the Government of Manitoba if any publicly funded health facility within the Province of Manitoba is used to provide these services; and
    4. is responsible to manage and support patient monitoring post infusion as appropriate for the Product.
Manitoba Health
Non-Insured Benefits Branch
300 Carlton Street
Winnipeg MB R3B 3M9
Phone: 204-786-7233
Toll free: 1-800-297-8099 extension 7233