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.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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