Notice - Drug Master File Fees

March 4, 2013

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Contact: Cost Recovery

Our file number: 13-103468-483

Fees for the Administration of Drug Master Files (DMFs)

Since the 1990's, Health Canada has been charging user fees to industry to cover a portion of the cost of its regulatory programs for drugs. In 2004, the Health Products and Food Branch undertook a significant project to update its cost recovery framework, which includes fees for administrative activities associated with Drug Master Files (DMFs). No requirement exists within the Food and Drug Regulations to submit or use DMFs. Therefore, the administration of DMFs constitutes a voluntary service provided by Health Canada for which fees may be established under Ministerial contracting authority.

The purpose of this Notice is to advise that updated fees have been introduced as per the Notice published in the  Canada Gazette Part I on March 2, 2013. The fees take effect for new DMF Registrations, Letters of Access and the DMF Biannual Updates received on or after April 1, 2013.

Prior notification of the intention to update fees for administrative activities associated with DMFs was given in the User Fee Proposal that was tabled by the Minister of Health on April 12, 2010 in the House of Commons, and tabled in the Senate on April 13, 2010. On May 26, 2010, the Senate adopted the report of its committee, thereby concluding the Parliamentary review of Health Canada's proposal.

DMFs

A DMF is a reference that provides drug evaluators confidential information not available to drug product manufacturers (sponsors) about specific processes and components used in the manufacturing, processing and packaging of a drug. DMFs are divided into four types:

• Type I: Active Pharmaceutical Ingredients/Drug Substance;
• Type II: Packaging Materials;
• Type III: Colourants, Flavours, and Other Additives; and
• Type IV: Drug Product.

A complete description of administrative procedures, data requirements and definitions related to DMFs is provided in the Drugs Directorate Guideline entitled Product Master Files (1994), which is the current adopted guidance. A revised version of the 1994 guidance in draft form is on the website to help further clarify information in the 1994 version.

Updated Cost Recovery Program

Updated fees will be charged for new DMF Registrations and the processing of authorizations (Letters of Access) and the processing of biannual updates received by Health Canada on or after April 1, 2013. These fees will be applied to the DMF owner or authorized agent to specific drug product manufacturers, as applicable.

Note: Costs associated with the evaluation of DMF information are recovered through the appropriate drug submission evaluation fee.

Fee Schedule

Drug Master File Activities Cost Recovered	Fees 2012	Fees 2013
Registration of a Drug Master File (original filing only)	$400 Cdn	$408 Cdn
Processing a Letter of Access (see Appendix 2 for a sample letter)	$180 Cdn	$184 Cdn
Processing of Biannual Updates	$180 Cdn	$184 Cdn

There will be an annual 2% increase to these fees.

Payment

A cheque, money order, credit card or bank wire for the total amount due, payable to the Receiver General for Canada in Canadian funds, must accompany new DMF Registrations, Letters of Access and Biannual Updates. Please refer to the Drug Master File Fee Form. Partial payment, or payment in non-Canadian funds, will result in the immediate return of documents, at the company's expense.

DMF correspondence, including new/updated DMFs and Letters of Access, should clearly indicate "Subject Matter: Drug Master File" and be addressed to:

Drug Master File Administrative Unit
Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
Address Locator 0201D
Ottawa, Ontario
K1A 0K9

DMF acknowledgement letters created by Health Canada will include confirmation of all information received, including payment.

Appendix 1: Example for Fees Charged

The following example illustrates how the fee form would be completed when a DMF owner/agent submits a single package containing:

• one new DMF for Registration;
• one Biannual Update for a DMF already registered by the owner; and
• one Letter of Access.

In this case, a cheque, money order, wire or credit card payment for $776.00 Canadian must be enclosed in order for this package to be processed by the DMF Administrative Unit. If any information is missing, such as fees, the entire package will be returned at the company's expense.

Notes

1. A separate Letter of Access is required for each Registered Drug Master File which the owner/agent is allowing Health Canada to access in support of a drug submission from a sponsor for a product line. For each Letter of Access, there is a $184 fee per product line.
2. A product line is a group of drug products containing the same active pharmaceutical ingredient(s) (API), irrespective of the dosage form, and manufactured/marketed by the company to which authorization to access the DMF is granted.
3. No tax will be applied to these fees.

Appendix 2: Sample Letter of Access

(Date)

(File Number)

Health Canada
Therapeutic Products Directorate
Submission and Information Policy Division
Drug Master File Administrative Unit,
101 Tunney's Pasture Driveway
Address Locator 0201D
Ottawa, Ontario
K1A OK9

Dear Sir or Madame:

RE: (Product Name) - DMF-0000

Please accept this letter as authorization for (sponsor name) to make reference to our Drug Master File, (state specific Drug Master File Name) in support of drug submission(s) for (state specific product line name^{Footnote 1}) to be filed with Health Canada.

This authorization is, however, subject to all applicable regulations regarding confidentiality of such information.

Yours sincerely,

(signature)