CSPs

As part of a number of UK/EU/Brexit amendments published today, the Certificate of Supplementary Protection Regulations were amended to add the UK as a “prescribed country”in addition to the EU.

As noted in the Regulatory Impact Analysis Statement:

In order to qualify for a CSP, applicants must file their Health Canada regulatory submission no later than one year after they file an equivalent submission in a country listed in the Regulations, which include EU member countries, the United States, Australia, Japan, and Switzerland. This obligation ensures that in order to qualify for a CSP, a new drug submission is filed early in Canada, which is historically a country of second filing, and speeds up access for Canadians to new life-saving drugs. The U.K. is currently captured by the Regulations as a “country that is a member of the European Union.”

The objective of the amendment is to add the U.K. as a separate qualifying jurisdiction to maintain continuity of policy intent.

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