On June 20, 2006, the Transparent Drug Systems for Patients Act, 2006 (the "TDSPA") received Royal Assent. Amongst other changes, the TDSPA transferred the powers of the Minister and the Lieutenant Governor in Council, in respect to matters related to administering the Ontario Drug Benefits Formulary, to the Executive Officer of the Ontario Public Drug Programs. The new Executive Officer (EO) has the authority to approve all changes to the Formulary.

As of February 2007, the Formulary is updated monthly to include both new multiple source (i.e., streamlined and non-streamlined) and single source drug products, and housekeeping changes.

• Monthly Formulary Updates
• Single Source Drug Products Submissions Review Process and Timelines
• Non-Streamlined Multiple Source Drug Products Submissions Review Process and Timelines
• Streamlined Multiple Source Drug Products Submissions Review Process and Timelines
• Policy on Receipt of Submissions
• Format and Organization of Submissions
• Letters Regarding Formulary Additions for Single Source and Non-Streamlined Multiple Source Drug Products

In order for a drug product submission to be considered for inclusion in the next monthly Formulary update by the Executive Officer, it must be received by the New Submission Deadline that is applicable to multiple source submissions and single source drug products submissions.

All streamlined multiple source drug products submissions must be received by the Ministry by 3:30 p.m. on this date in order to be considered for the next Formulary update. See Policy on Receipt of Submissions.

A new drug product submission proposed to be listed in the Formulary must meet the regulatory requirements as prescribed in R.R.O. 1990, Regulation 935 under the Drug Interchangeability and Dispensing Fee Act and O. Reg. 201/96 under the Ontario Drug Benefit Act. Additionally, a submission must also include all applicable supporting documentation as set out in the Ontario Guidelines for Drug Submission and Evaluation and any applicable supplementary documents issued by the Ministry in order to be deemed complete for recommendation to the Executive Officer for his/her review and decision. The Ministry may request additional information from manufacturers at any time during the screening and/or review process.

Please be advised that if any of the submission documents or materials is found to be deficient in any respect, irrespective of whether the deficiency goes to form or content, the submission request for the proposed listing of the drug product on the Formulary will automatically be deemed incomplete. If a submission is incomplete, the manufacturer must wait until the following monthly New Submission Deadline before its drug product submission will be screened. Please be aware that the onus is on the manufacturer to provide the Ministry with complete and accurate information regarding its submission. This policy was published on the Ministry website on October 1, 2007 as a Notice to Manufacturers – Submission Requirements for Generic Drug Products and applies until further notice.

Submissions for a Notification of Change will be screened and evaluated according to the current process, as outlined in the Ontario Guidelines for Drug Submission and Evaluation.

New Submission Deadline Dates for All Products 2008

Note : The Ministry reserves the right to change the new submission deadline date. Changes will be posted on this website approximately 30 days before any new submission deadline date becomes effective. The onus will be on the manufacturers to check the BBS notifications and this website on a regular basis.

1. The Ministry screens submissions for compliance with the regulatory requirements and issues a Notice of Drug Submission Status.
2. The Executive Officer (EO) may begin discussions with the manufacturer to negotiate price and listing agreements at any time after receipt of a proposal from the manufacturer.
3. The submission is sent to an expert reviewer who reviews the submission and prepares a written report. This only occurs once the submission has been found to meet all regulatory requirements.
4. The reviewer report is forwarded to the CED for presentation at the next scheduled CED meeting. The CED generally meets once monthly, on the 2nd Wednesday of the month. Minutes from the CED meeting are prepared and circulated to members to be ratified. It takes approximately 2-3 weeks for the CED minutes to be finalized. Although actual ratification of minutes only occurs at the next CED meeting.
5. Letters detailing the CED recommendations are prepared by Ministry staff and sent to the manufacturers. After required approvals are obtained, the letters are faxed to the manufacturer.
6. Posting of the CED recommendation and rationale may occur at any time after the CED minutes have been ratified (Please refer to the Transparency Guidelines).
7. Where the CED has made a positive listing recommendation, manufacturers are required to confirm the pricing of their product and Drug Identification Number (DIN) within one week.
8. Once price and DIN are confirmed, the submission package is prepared for the EO's review and approval. The EO may designate a drug product in the Formulary as a listed drug product only where the EO considers it to be in the public interest to do so.
9. Following approval by the EO, the Formulary update is published on the Ministry website and communicated to industry stakeholders via the electronic Bulletin Board System (BBS). The effective date of the Formulary is generally 7 business days following the issue of the BBS notice.
10. Single source drug products, from a positive funding recommendation by the CED to the effective date of the Formulary update, takes approximately 8-10 weeks. Products requiring ongoing price and /or listing agreement negotiations may take longer.

1. The Ministry screens submissions for compliance with the regulatory requirements and issues a Notice of Drug Submission Status.
2. The submission is sent to an expert reviewer who reviews the submission and prepares a written report. This only occurs once the submission has been found to meet all regulatory requirements.
3. The reviewer report is forwarded to the CED for presentation at the next scheduled CED meeting. The CED generally meets once monthly, on the 2nd Wednesday of the month. Minutes from the CED meeting are prepared and circulated to members to be ratified It takes approximately 2-3 weeks for the CED minutes to be finalized, although actual ratification of minutes only occurs at the next CED meeting.
4. Letters detailing the CED recommendations are prepared by Ministry staff and sent to the manufacturers. After required approvals are obtained, the letters are faxed to the manufacturer.
5. Where the CED has made a positive listing recommendation, manufacturers are required to confirm the pricing of their product and Drug Identification Number (DIN) within one week.
6. Once the price and DIN are confirmed, the submission package is prepared for the EO's review and approval. The EO may designate a drug product in the Formulary as a listed drug product only where the EO considers it to be in the public interest to do so.
7. Following approval by the EO, the Formulary update is published on the Ministry website and communicated to industry stakeholders via the electronic Bulletin Board System (BBS). The effective date of the Formulary is generally 7 business days following the issue of the BBS notice.
8. For approved non-streamlined multiple source drug products, the entire submission review process, from the new submission deadline to the effective date of the Formulary update, takes approximately 10 to 12 weeks.

1. Oral solid dosage form and some aqueous products with Health Canada declaration of equivalence are screened and recommended by the Ministry for listing. They are not reviewed by the CED.
2. The Ministry endeavours to process all new streamlined multiple source submissions within 5 (five) business days of the new submission deadline.
3. The Ministry screens submissions for regulatory requirements and issues a Notice of Drug Submission Status (NDSS). The NDSS letter will be faxed by 3:30 p.m. on the 6th business day after the new submission deadline.
4. Generic products are generally priced at 50% of the original product (typically the brand name product) unless it is the first listed generic product. In these situations, the EO may negotiate a price other than at 50% of the original product price. The EO may also negotiate prices of less than 50% of the original product price. Please note that even if the manufacturer meets the exemption requirement, the EO is not required to negotiate a drug benefit price (DBP) higher than at 50 % of the original product price. Where the Executive Officer and the manufacturer cannot agree as to the DBP, the EO will not list the proposed drug product.
5. If the submission is complete, price and DIN confirmations made by the manufacturer will occur by the 7th business day after the new submission deadline date, i.e. 1 day after the NDSS letter has been faxed.
6. Once price and DIN are confirmed, the submission package is prepared for EO review and approval, i.e., 3 weeks from the New Submission Deadline date. The EO may designate a drug product in the Formulary as a listed drug product only where the EO considers it to be in the public interest to do so.
7. Following approval by the EO, the Formulary update is published on the Ministry website and communicated to industry stakeholders via the electronic Bulletin Board System (BBS). The effective date of the Formulary is generally 7 business days following the issue of the BBS notice.
8. The entire process for an approved multiple source drug product takes, from the new submission deadline date to the effective date of the Formulary update, approximately 6 weeks (this excludes the time required for price negotiation).

Please note the following key changes to the process for reviewing submissions for multiple source products as a result of streamlining to a monthly submission cycle.

Given the short submission review cycle, the Ministry will NOT accept Priority Review requests for ANY multiple source products (streamlined and non-streamlined submissions).

There will only be one opportunity per cycle for a manufacturer to make a complete submission for a particular product as a multiple source submission. All Notice of Drug Submission Status (NDSS) letters (both complete and incomplete) will be sent out by 5 p.m., six (6) business days after the new submission deadline. If the submission is complete, manufacturers will be asked to respond to the Ministry within 24 hours only if the data (DIN, price) provided in the letter is incorrect. Otherwise, no further price or DIN confirmation is required.

If there is no response from the manufacturer, the product(s) will go forward for consideration by the Executive Officer with no changes. If the manufacturer responds with a correction within the 24-hour timeframe, the Ministry will make the appropriate changes so that the product(s) will go forward for consideration by the Executive Officer.

The Ministry acknowledges that multiple source submissions involving cross-licensed agreements will have difficulty meeting the timelines described above. Past experience has demonstrated that these submissions often lack the necessary documentation to demonstrate which company has legal liability for the price, supply or manufacturing of the drug product.

Effective February 1, 2007, the Ministry will not accept faxed submissions. ALL submissions (i.e. streamlined and non-streamlined) must be delivered by either courier services or in person by the manufacturer to Ontario Public Drug Programs at 5700 Yonge Street, 3^rd Floor, Toronto ON M2M 4K5.

For streamlined multiple source product submissions, the complete submission must be received by the Ministry staff of Ontario Public Drug Programs, at 5700 Yonge Street, 3^rd Floor, Toronto ON M2M 4K5 before 3:30 p.m. on the New Submission Deadline Date posted.

Three separate copies of the entire submission must be provided for the single source submissions, and two separate copies must be provided for the multiple source submissions, diabetic testing agent submissions and the nutritional products submissions.

This also applies for responses to any deficiency from the Ministry's NDSS or recommendation letters i.e., three copies for single source and two copies for multiple source, diabetic testing and nutritional products submissions.

All submissions must be organized and indexed. Binders should be sturdy and not overfilled. Manufacturers should restrict individual binders to a maximum of 3 inch width. Duplexed (double sided) pages are preferred.

To facilitate the review of the clinical/bioequivalence data, as required, manufacturers should not submit analytical raw data (laboratory analytical test preparation, LC/GLC chromatograms) for review. The Ministry may return the submission to the manufacturer at their expense, without prejudice to refilling.

All submissions for single source products must include unlocked (executable) copies of both the Pharmacoeconomic model and the Budget Impact Analysis which can be manipulated; details of methods used in the modeling exercises; basic user information to enable manipulation of the model including the ability to vary individual parameters, view the calculations and run the model to generate results.

The Ministry will continue to send the CED recommendation letters to manufacturers; however, the Ministry will no longer send individualized letters to manufacturers to inform them of Formulary Update changes. The notification sent by BBS will now be considered the official notification of government approval. The onus will be on the manufacturers to sign up to receive these BBS notifications.

To sign up for notification via the BBS, please send an email to DrugBenefits@moh.gov.on.ca with the following contact information :

• first and last names
• title
• company name
• address with postal code
• business telephone number
• business fax number
• alternate/cellular telephone number
• email address where you would like to receive BBS