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.