AUTHOR: Reynaldo Roman – Senior Director, Regulatory Compliance

U.S. Customs and Border Protection (CBP) has issued guidance implementing tariff-related elements of the U.S.–EU Framework Agreement on Reciprocal, Fair, and Balanced Trade, which was announced on August 21, 2025, and subsequently authorized by Executive Order 14346 on September 5, 2025. This action directly affects how pharmaceutical imports from EU member countries are treated.

Pharmaceutical Exemption
Unpatented pharmaceutical products of EU member countries that are classified in one of the HTSUS subheadings enumerated in subdivision (v)(xix) of U.S. Note 2 to Subchapter III of Chapter 99 of the Harmonized Tariff Schedule of the United States (HTSUS) are exempt from the 15% reciprocal tariff when entered on or after September 1, 2025. Importers must file these products under 9903.02.77 and maintain documentation confirming both their unpatented status and proper classification under the covered HTSUS provisions.

Effective Date – Retroactive Application
Although CBP issued this guidance in late September, the exemption applies retroactively to entries filed on or after September 1, 2025. Importers who have already entered qualifying EU pharmaceutical products on or after this date are entitled to relief, even if duties were initially assessed at the 15% reciprocal tariff rate.

Non-Exempt Pharmaceuticals
If an EU pharmaceutical product does not meet the criteria for this exemption or any other applicable exemption (such as the exemptions in Annex II), it remains subject to the 15% reciprocal tariff.

Key Takeaway for Importers
For pharmaceutical importers, this exemption offers significant relief by eliminating the 15% reciprocal tariff on covered medicines and inputs. Companies should ensure accurate HTSUS classification and maintain documentation to substantiate eligibility under subdivision (v)(xix) of U.S. Note 2 to Subchapter III of Chapter 99.

Ensuring service reliability remains our top priority. Marken remains committed to supporting clients in navigating the regulatory and trade landscape.

For more information or further clarification on how these requirements apply to your specific shipments, please contact our team at TradeCompliance@marken.com.