Drug Submission Requirements Checklist for Patented Drug Products (Category 1 and 2) and Biosimilars to the BC Ministry of Health

CATEGORY 1 DOCUMENTS AND INFORMATION REQUIRED FOR PATENTED DRUG PRODUCTS REVIEWED BY THE CANADIAN AGENCY FOR DRUG AND TECHNOLOGIES IN HEALTH (CADTH) COMMON DRUG REVIEW (CDR) AND BY THE BC MINISTRY OF HEALTH

Category 1 and biosimilar documents and information are required by the CDR review team, the Canadian Drug Expert Committee (CDEC), and the BC Ministry of Health for drug submission review and recommendation processes.

When submitting Category 1 documents and information for (1) New Drugs, (2) Drugs with New Indications, (3) New Combination Products to the CDR for Review, and (4) biosimilar products, drug submission sponsors must:

  • Include Ministry-specific Category 1 documents in the submission to the Ministry of Health
  • Follow and meet the required Category 1 documents in the CDR Drug Submission Guidelines (PDF 1,194MB)  
  • Follow and meet the required biosimilar document requirements, as listed in the CADTH Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics (PDF 690KB).
  • Send the complete drug submission package of CDR Category 1 documents to the Ministry of Health at the same time as they submit their drug submission package to the CDR
  • Submit one copy of the complete submission requirements on a USB flash drive to the Ministry of Health. The USB flash drive should be unlocked and fully executable. NEW: Hard/paper copies of drug submissions are no longer accepted
  • Read and follow the checklist of required documents below to ensure the submission package is complete
  • Send the complete drug submission package of CDR and Ministry-specific Category 1 documents to the courier address below:

Courier Packages to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street
Victoria BC  V8W 3C8

Regular Correspondence to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Below are detailed checklist of Category 1 documents required by the Ministry of Health and the CDR.

Note:

  • All letters submitted specifically to the Ministry of Health, unless otherwise stated in the checklist, must be prepared on company letterhead, signed by an appropriate senior official, and submitted as an electronic copy
  • For biosimilar products only, drug submission sponsors should be aware of the following:
    • The Ministry of Health has specific biosimilars document requirements which are the same as those listed in the document checklist of Ministry-specific Category 1 patented drug products
    • Not all documents and information listed in the various checklists will be available for biosimilar products
    • Prepare a letter printed on company letterhead, which is signed by an appropriate senior official and submitted to the Ministry of Health as an electronic copy, that refers to the specific biosimilar documents that are listed below and that will be included or will not be included in the complete drug submission package
    • Send the complete drug submission package of biosimilars documents to the Ministry of Health at the same time as the package is submitted to the CDR
  • Documents required by the CDR (e.g., letters) should be addressed to the CDR
  • Documents required by the Ministry of Health (e.g., letters) should be addressed to the Director of Formulary Management at the Ministry of Health
  • Only complete drug submission packages that follow the checklist criteria and that include all checklist documents will be reviewed
  • NEW: If BC-specific Category 1 documents are not ready at the time CDR Category 1 documents are submitted, then the BC specific Category 1 documents can be sent later when the BC-specific and CDR Category 2 documents are submitted
  • The checklist of required Category 1 documents specific to the CDR should not be used to replace the CDR Drug Submission Guidelines (PDF 1,194MB) which is more detailed.
  • Drug submission sponsors are not required to send any Category 1 documents that are specific to the Ministry of Health to the CDR.
  • If you have any questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca


Checklist of required Category 1 documents specific to the Ministry of Health

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Documents with *Signature Required* must be signed by an appropriate senior official.
  • Documents may be signed using an e-signature. When printing hard copies to sign and scan, use blue ink. 
  • Some documents must be submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Cover letter    *Signature Required*

The cover letter, printed on company letterhead and signed by an appropriate senior official, should identify:

  • the type of drug submission to be reviewed
  • each indication, strength and the Drug Identification Number (DIN) to be reviewed
  • the name of each vendor/associate company working on the submission
  • contact information for the primary and backup person who can be contacted regarding the submission under review.

❏ Letter confirming that written notification of any future changes will be provided    *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming the availability of the drug pre-NOC  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming ability to supply for anticipated demand  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

Letter confirming that Periodic Safety Update Reports submitted to Health  Canada will also be submitted to the Ministry of Health  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter declaring that all known unpublished studies have been disclosed  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Table of all known ongoing trials for indications different than the indication being submitted for review

Access applicable information and templates from:

Letter of consent authorizing unrestricted communication and sharing of information  *Signature Required*

The letter, printed on company letterhead and signed by an appropriate senior official, authorizes the Ministry of Health to share information with respect to the drug product under review, with:

  • Health Canada
  • Other provinces and territories
  • CADTH/CDR (Canadian Agency for Drugs and Technologies in Health/Common Drug Review)
  • PMPRB
  • Health authorities including regional health authorities
  • Contracted third party reviewers who are subject to a signed confidentiality agreement.

❏ All Pharmaceutical Advertising Advisory Board (PAAB)-approved promotional materials or draft copies of materials submitted to PAAB


Checklist of required Category 1 documents specific to the CDR

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Some documents must be signed by an appropriate senior official (e.g., *Signature Required*) or submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Completed CDR application overview template

❏ Cover letter  *Signature Required*

❏ Executive summary

❏ Product monograph

Health Canada Documentation

❏ NOC or Notice of Compliance with conditions (NOC/c)

❏ Health Canada clinical reviewers’ report

❏ Table of Clarifaxes

Efficacy, Effectiveness, and Safety Documentation (Including supplementary appendixes)

 Common Technical Document sections 2.5, 2.7.1, 2.7.3, 2.7.4, 5.2, or statement indicating any section(s) not required for the Health Canada submission

❏ Reference list of clinical studies and errata

❏ Clinical studies

❏ Table of studies

❏ Reference list of editorial articles (or statement that no editorials)

❏ Copies of editorial articles

❏ Literature search strategies

❏ Letter declaring that all known unpublished studies have been disclosed  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ CONSORT diagrams

❏ Reference list and copies of new data

❏ Reference list of articles for validity of outcome measures

❏ Copies of articles for validity of outcome measures

Economic and Epidemiologic Documentation

❏ Pharmacoeconomic evaluation for the full population identified in the approved Health Canada indication(s) to be reviewed by CDR

❏ Economic model used in the initial submission

❏ Number of patients accessing a new drug to within 20 business days of the submission being filed

❏ Disease prevalence and incidence data, with specified population breakdown (if available)

Pricing and Distribution Documentation

❏ Summary list and/or table on the unit price for all dosage forms, strengths and package sizes, to four decimal places

❏ Method of distribution

❏ Commitment to honour the submitted price  *Signature Required*

Sharing of Information

❏ Letter authorizing unrestricted sharing of information  *Signature Required*

Pre-NOC Letters

❏ Letter for sending the NOC or NOC/c to CADTH  *Signature Required*

❏ Letter for finalized Category 1 requirements if submission filed on a pre-NOC basis  *Signature Required*

Important: The Ministry of Health reserves the right to ask for additional information as required. The drug submission sponsor must submit any required electronic documentation in accordance with copyright permissions. 


CATEGORY 2 DOCUMENTS AND INFORMATION REQUIRED FOR PATENTED DRUG PRODUCTS REVIEWED BY THE CANADIAN AGENCY FOR DRUG AND TECHNOLOGIES IN HEALTH (CADTH) COMMON DRUG REVIEW (CDR) AND BY THE BC MINISTRY OF HEALTH

Category 2 documents and information are required by Canadian drug plans only, including the Ministry of Health, for drug submission review and recommendation processes. CADTH provides secretariat support to the drug plans by gathering Category 2 requirements and ensuring that the documents are complete. The CDR does not use Category 2 documents and information as part of their review and recommendation processes.

When submitting Category 2 documents and information for (1) New Drugs, (2) Drugs with New Indications, (3) New Combination Products to the CDR for Review, and (4) biosimilar products, drug submission sponsors must:

  • Include Ministry-specific Category 2 documents in the submission to the Ministry of Health
  • Follow and meet the required Category 2 documents in the CDR Drug Submission Guidelines (PDF 1.194MB)  
  • Follow and meet the required biosimilar document requirements, as listed in the CADTH Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics (PDF 690KB).
  • Send the complete drug submission package of CDR Category 2 documents to the Ministry of Health at the same time as they submit their drug submission package to the CDR. NEW: The Ministry does not accept hard/paper copies of drug submissions. The Ministry requires one electronic copy of their complete submission on a USB flash drive that is unlocked and fully executable to the Ministry.
  • Read and follow the checklist of required documents below to ensure the submission package is complete
  • Send the complete drug submission package of CDR and Ministry-specific Category 2 documents to the courier address below:

Courier Packages to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street
Victoria BC  V8W 3C8

Regular Correspondence to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Below are detailed checklist of Category 2 documents required by the Ministry of Health and the CDR.

Note:

  • All letters submitted specifically to the Ministry of Health, unless otherwise stated in the checklist, must be prepared on company letterhead, signed by an appropriate senior official, and submitted as an electronic copy
  • For biosimilar products only, drug submission sponsors should be aware of the following:
    • The Ministry of Health has specific biosimilars document requirements which are the same as those listed in the document checklist of Ministry-specific Category 2 patented drug products
    • Not all documents and information listed in the various checklists will be available for biosimilar products
    • Prepare a letter printed on company letterhead, which is signed by an appropriate senior official and submitted to the Ministry of Health as an electronic copy, that refers to the specific biosimilar documents that are listed below and that will be included or will not be included in the complete drug submission package
    • Send the complete drug submission package of biosimilars documents to the Ministry of Health at the same time as the package is submitted to the CDR
  • Documents required by the CDR (e.g., letters) should be addressed to the CDR
  • Documents required by the Ministry of Health (e.g., letters) should be addressed to the Director of Formulary Management at the Ministry of Health
  • Only complete drug submission packages that follow the checklist criteria and that include all checklist documents will be reviewed
  • The checklist of required Category 2 documents specific to the CDR should not be used to replace the CDR Drug Submission Guidelines (PDF 1,194MB) which is more detailed.
  • Drug submission sponsors are not required to send any Category 2 documents that are specific to the Ministry of Health to the CDR.
  • If you have any questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca


Checklist of required Category 2 documents specific to the Ministry of Health

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Documents with *Signature Required* must be signed by an appropriate senior official.
  • Documents may be signed using an e-signature. When printing hard copies to sign and scan, use blue ink.
  • Some documents must be submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Letter confirming ability to supply for anticipated demand  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Drug Product Request Form for Patented Drug Products and Biosimilars

*Applies to Common Drug Review (CDR) Submissions Only* 

Access and complete the Ministry of Health Drug Product Request Form for CDR Submissions as a Word document. In the template, include the following:

  • Each indication, strength and the Drug Identification Number (DIN) to be reviewed.
  • The name of the drug manufacturer and each vendor/associate company working on the submission.
  • Contact information for the primary and backup person who can be contacted regarding the submission.
  • A high-level executive summary describing the submission.

❏ Budget Impact Analysis (BIA) for BC  *Submit as PDF and Excel*

The BIA for BC must be:

❏ BIAs for Other Drug Plans  *Submit as PDF and Excel*

The BIA’s for other drug plans in Canada must be:

❏ Summary list of the drug submission product’s associated patents and the patent expiry dates as documented on the Health Canada Patent Register


Checklist for required Category 2 documents specific to the CDR

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Some documents must be signed by an appropriate senior official (e.g., *Signature Required*) or submitted in multiple electronic formats (e.g., *Submit as PDF and Excel*).
General Documentation

❏ Cover letter confirming that all Category 2 requirements have been provided  *Signature Required*

Budget Impact Analysis and Supporting Documentation

❏ Budget Impact Analysis (BIA)  *Submit as PDF and Excel*

  • Include BIAs for the following jurisdictions’ drug plans, in accordance with their individual requirements: British Columbia (BC), Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador, and the Non-Insured Health Benefits Program.
    • When data specific to Prince Edward Island are unavailable, the BIA for Prince Edward Island is to be based on Nova Scotia data.
  • The base unit price used in the BIAs must be the same as the price submitted in the Category 1 requirements and must be clearly identified in each BIA. Jurisdiction-specific markups or discounts can then be applied, if applicable.

❏ Copies of all supporting documentation used and/or cited in the BIAs

Certified Product Information Document (CPID)

❏ Copy of approved CPID

Additional Information (that may be requested)

❏ Harms and Safety information

❏ Periodic Safety Update Reports as submitted to Health Canada

❏ Clinical Study Reports

Important: The Ministry of Health reserves the right to ask for additional information as required. The drug submission sponsor must submit any required electronic documentation in accordance with copyright permissions.