Form 2, Block 4 and Block 5 Online Filing Help

Block 4 - Sales of the Medicine by the Rights Holder in Final Dosage Form in Canada

The detailed information provided in the Block 4 relates to quantity and revenues of Canadian sales of the drug product, in final dosage form under the PMPRB’s jurisdiction for a specific Rights Holder.

Drug Identification Number (DIN) or Number Assigned by the PMPRB

• Strength/Unit as coded in the PMPRB electronic system on the basis of the information submitted by the Rights Holder in the Form 1 for the medicine. Please note that the unit refers to the unit of price review which should be the same as the unit reported in the NOC and on Form 1.
• Dosage Form as coded in the PMPRB electronic system on the basis of the information submitted by the Rights Holder for the medicine.
• Package Sizes  are based on Compendium of Pharmaceuticals and Specialties (CPS) information. Since package sizes vary over time, a Rights Holder can add new package sizes or delete obsolete package sizes that are on the templates. A package size should be a numeric value representing the number of ‘units’ in the package (please refer to the unit reported under strength/unit on the template).

The fields where the number of packages sold, net revenue or average price per package, and province/territory are reported must be completed by the Rights Holder. A Rights Holder may choose to report the sales, promotions, rebates, free goods etc. on separate rows. Please make sure that each line of information is fully completed and includes DIN or Assigned Number, Strength/Unit, Dosage Form, Package Size, Number of Packages Sold, and Net Revenues or Average Price/Package.

Number of Packages Sold

Indicate for each DIN or Assigned Number the total number of packages sold including quantities distributed for promotions, rebates, free goods, etc. (see Subsections 4(4) and 4(5) of the Regulations) during the reporting period. The date of sale is considered to be the date the product was shipped, not the date payment was received. Returns (i.e., product returned to the Rights Holder/former Rights Holder for which a refund was provided) are to be included with the data of the reporting period in which the Rights Holder or former Rights Holder received the return. Only Canadian sales of the medicine in final dosage form are to be reported.

Net Revenue or Average Price per Package

Record the Net Revenue whenever possible, otherwise provide the Average Price per Package that corresponds to the number of packages sold. Report in dollars and cents – do not round up to the nearest dollar.

Net revenue consists of actual sales revenue using the accrual accounting method (excluding federal/harmonized sales tax) for the drug product sold (i.e., shipped) during the reporting period less amounts disbursed for rebates, refunds, or other such type of reduction during the same period (see Subsections 4(4) and 4(5) of the Regulations).

The average price per package is defined as net revenue (excluding federal/harmonized sales tax) divided by the total number of packages sold (or distributed as part of a promotion, rebate, etc.).

Province/Territory

Use codes provided in   in the table below to complete these fields or use the dropdown menu available in the Form 2 Block 4 template (place your cursor in the cell where you want to enter the code in the Province/Territory column and single click to access the dropdown menu).

Table 1: Block 4 Province/Territory Country Codes

*use when the province is unknown or when the prices in ALL provinces are the same

Please note that a breakdown of sales by province must be provided in Block 4. Code 13 should be used only when it is not known in which province the sales have occurred.

Block 5 - Publicly available Ex-Factory Prices for Canada and Other Countries

Information in Block 5 covers publicly available ex-factory prices in Canada and in the eleven countries listed in the Regulations (Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and United Kingdom), for all final dosage forms of the medicine.

Use the Form 2 Block 5 template specific to your organization that is sent by PMPRB Staff following receipt of Form 1 or prior to the filing deadline for the semi-annual regulatory filing. The Form 2 Block 5 template already includes the following information for every patented drug product under the PMPRB’s jurisdiction for a specific Rights Holder:

• Medicinal name as recorded in the PMPRB electronic system based on the information submitted in Form 1 and the Product Monograph
• Drug Identification Number (DIN) or Assigned Number
• Strength/unit as in Block 4
• Dosage Form as in Block 4
• Package Size: Please note that a Rights Holder can add new package sizes or delete obsolete package sizes that are on the templates.

Each field of the row where a DIN or Assigned Number is reported should be fully completed to include the medicinal name of the medicine, DIN, strength/unit, dosage form, package size, ex-factory price, and country or province. Add as many rows as needed by using the ‘Insert Row’ function in the menu item in Excel or by placing the cursor on the row below which a new row must be added and using the right click/insert function of the mouse. Rows can be deleted either by using the menu item at the top of the screen or by using the right click/delete function of the mouse.

Ex-factory Price

Enter the publicly available ex-factory price per package at which the drug product was sold during the reporting period indicated in Block-1 or Block 2, if an amendment. The publicly available ex-factory price includes any price of a patented medicine that is agreed on by the Rights Holder or former Rights Holder and the appropriate regulatory authority of the country in which the medicine is sold by the Rights Holder (see subsection 4(9) of the Regulations).  State the public ex-factory price in the currency of the country in which it was sold.

If there is more than one ex-factory price for a particular country/province for a reporting period, all ex-factory prices for the drug product must be reported.

Important: The Rights Holder or former Rights Holder must supply public foreign ex-factory price data for all patented drug products that the Rights Holder/former Rights Holder sells or has sold in Canada. This is necessary even if the Rights Holder/former Rights Holder itself does not sell/has not sold the product in any of the eleven foreign countries. The information that is reported must pertain to the same patented drug product. It is not permitted to simply include prices relating to the same active ingredient. Rights Holders and former Rights Holders who are unsure of, or have difficulty acquiring, foreign ex-factory price data should contact PMPRB Staff for advice.

A Block 5 including the publicly available ex-factory price(s) for Canada must be submitted even if the product is sold in none of the eleven countries listed in the Regulations.

Use a separate line to report each combination of ‘strength/dosage form/package size’, and ‘country/ province’ that applies. PMPRB Staff may request a Rights Holder to provide supportive documentation of its ex-factory price, on a case-by-case basis.

Country or Province

Use codes provided in the table below to complete these fields or use the dropdown menu available in the Block 5 template (Place your cursor in the cell where you want to enter the code in the Country/Province column and single click to access the dropdown menu). If the publicly available ex-factory price is the same in every Canadian province where the product is sold, use the province code ‘13’ to signify all of Canada instead of listing each province separately.

Table 2: Block 5 Country Codes