Canada's Access to Medicines Regime
camr-rcam.gc.ca
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Forms
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.