Potential Sources for Foreign Prices: PMPRB11

Starting with July 1, 2022, the Patented Medicines Regulations require rights holders to report the publicly available ex-factory prices at which they sell their products in any of the eleven comparator countries specified in the amended Patented Medicine Regulations as opposed to the list of seven comparator countries that existed previously.

In the countries specified in the Regulations (i.e., Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom), the PMPRB has identified examples of potential sources for the benefit of rights holders. Rights holders must, nevertheless, consult the appropriate sections of the Regulations and file foreign ex-factory prices in accordance with the Regulations (see s. 4(1)(f)(iii) and s. 4(9)).