Brexit prompts amendment to CSP Regulations

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On December 21, 2020, the Certificate of Supplementary Protection Regulations were amended to add the United Kingdom as a “prescribed country” for the purpose of determining the timeliness of the Certificate of Supplementary Protection (CSP) applicant’s New Drug Submission. The amendment was a consequence of Brexit; the U.K. was previously a prescribed country as a member of the European Union.  The amendment came into force on January 6, 2021, and the CSP Guidance Document and Application Form were updated accordingly as of that date.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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