Information Sheet - Management of Drug Company Contact and Financial Account Information

1. Unique 4 or 5 digit Company Code

Every drug company that Health Canada interacts with in the areas of Drug Submissions, Drug Right to Sell, and Drug Establishment Licencing is assigned its own unique 4 or 5 digit company code [for example (e.g.), 9797: we will use this code as our example throughout]. We may interact with your particular company in one or more of these project areas.

This company code is assigned the first time your company formally submits information to Health Canada - usually at the time of your first drug submission or your first drug establishment licence application. Once this code is assigned, it becomes the means by which we identify your company in our drug regulatory databases. You will see your company code on the first page of the Annual Drug Notification Form. The code is located in the centre of the page directly above the company's name.

2. The 3 main drug regulatory databases

There are 3 prefixes that we use internally to link your company code within our three main regulatory databases.

DRSE9797- identifies your company in all matters relating to Drug Submission Evaluations (DRSE). The database that contains your company's submission information is called the Drug Submission Tracking System (DSTS).

DPD9797 - identifies your company in all matters relating to drug identification number (DIN) issuance and notification [Drug Product Database (DPD)]. The database that contains your company's DIN information is called the Drug Product Database (DPD).

DEL9797 - identifies your company in all matters relating to Drug Establishment Licencing (DEL). The database that contains your company's Establishment Licencing information is called the Drug Establishment Licencing (DEL).

3. Your Financial Accounts

The three areas of activity shown above are subject to cost recovery. The Health Canada areas under which the funds are recovered are distinct and are managed in the finance system in three separate financial project areas. Again, your company code plays an important role and the prefixes DRSE, DPD, and DEL, along with your company code, are your financial account numbers. For example, DRSE9797 is the account that handles all your submission-related financial transactions, DPD9797 is the account that handles all Drug Right to Sell transactions and DEL9797 is the account that handles all Drug Establishment Licencing financial transactions. You will see these account numbers on all financial correspondence we send to you, and by looking at the prefix, you will know which type of account is involved.

4. Ownership of Financial Accounts

Like any bank account at a financial institution there is an identified account owner for each account we set up. This owner is responsible for payment of invoices, is authorized to request refunds (on overpayments), and is authorized to transfer credit balances from one account to another (e.g., from DRSE9797 to DPD9797).

DRSE and DPD accounts are set up in the name of the registered Notice of Compliance (NOC) / DIN owner. We use the information you provide on your Health Canada 3011 Drug Submission Application Form, your Submission Fee Form, and the information you provide to us through Annual Notification to determine the correct name/address for each account owner. If you have various divisions within your company, and each is a registered DIN owner, then each division will have its own unique 4 or 5 digit company code and its own unique financial accounts. In the case of DEL accounts the ownership is in the name of the Licence Holder and is taken from your Drug Establishment Licence Application Form.

Account ownership is reflected in the "FOR" information that appears on all your invoices and statements. In addition to the "FOR" information block you will also notice a "TO" information block on all invoices and statements - this is where the account holder has instructed us to send their invoices and statements. The "To" company name and address may be different from the actual account owner - but it is important to remember that the account owner has the overall responsibility for the account.

Invoices and statements are never directed to the attention of an individual - they are directed to "Regulatory Affairs" at the "TO" company name and address for the account owner. Please ensure that the address shown in A3 of your Annual Drug Notification Form reflects the address to which you want the invoice to be sent.

5. Changing your Company Name, Moving, or Merging with another company

It is very important that you keep us informed of any changes to your company information so that we may keep our regulatory and financial information current. It is particularly important that you inform us of any proposed company name changes or intended mergers so that we may advise you of the regulatory requirements in advance of the change. In many cases, there is a requirement to register these changes, and the Food and Drug Regulations may require that you file a new application for each affected drug product (Section C. 01.014.4). You will find further guidance in the following documents which may be found on the Health Canada website:

• Changes in Manufacturer's Name and/or Product Name
• Management of Drug Submissions Policy

Please note that if you are a company/manufacturer outside Canada, you are required to provide information related to your Canadian importer.

Your company code is very important to us and to you. While it is not mandatory that you reference it in all your correspondence to us, it does help us identify you correctly.

We do not recycle company codes - we retire them!

If you would like more information about company codes or account set-up, please email hc.client.information.sc@canada.ca.