Forms: Canada's Access to Medicines Regime Documents

The most up-to-date forms to obtain authorization in Canada are available on the Canadian Intellectual Property Office (CIPO) Web site. The required CIPO forms include:

• Application for Authorization Under Section 21.04 of the Patent Act: Application for a compulsory licence to manufacture and export a generic version of a patented pharmaceutical product or medical device.
• Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act: Declaration that the applicant sought a voluntary licence from the patent holder or holders.
• Solemn or Statutory Declaration Under Clause 21.04(3)(d)(i)(A) of the Patent Act: Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule 2, WTO member, product not patented).
• Solemn or Statutory Declaration Under Paragraph 21.04(3)(d)(i)(B) of the Patent Act: Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule 2, WTO member, product is patented).
• Solemn or Statutory Declaration Under Paragraph 21.04(3)(d)(ii)(A) of the Patent Act: Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule 2, not WTO member, product not patented).
• Solemn or Statutory Declaration Under Paragraph 21.04(3)(d)(ii)(B) of the Patent Act: Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule 2, not WTO member, product is patented).
• Solemn or Statutory Declaration Under Paragraph 21.04(3)(d)(iii)(A), (iv)(A) or (v)(A) of the Patent Act: Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule  3 or 4, product not patented).
• Solemn or Statutory Declaration Under Paragraph 21.16(1)(b) of the Patent Act: Declaration regarding the monetary value of the pharmaceutical product or medical device and the number of units to be manufactured and sold.
• Application for Renewal of Authorization Under Section 21.12 of the Patent Act: Application for renewal of authorization for compulsory licence.