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Committee on Technical Barriers to Trade - Agreement reached by a Member with another country or countries on issues related to technical regulations, standards or conformity assessment procedures - Notification - United States of America

United States of America
2023/07/31
已被閱讀 117次
G/TBT/10.7/N/170

GTBT10_7N170.pdf

AGREEMENT REACHED BY A MEMBER WITH ANOTHER COUNTRY OR COUNTRIES
ON ISSUES RELATED TO TECHNICAL REGULATIONS, STANDARDS
OR CONFORMITY ASSESSMENT PROCEDURES

NOTIFICATION

Under Article 10.7 of the Agreement "Whenever a Member has reached an agreement with any other country or countries on issues related to technical regulations, standards or conformity assessment procedures which may have a significant effect on trade, at least one Member party to the agreement shall notify other Members through the Secretariat of the products to be covered by the agreement and include a brief description of the agreement." The following notification under Article 10.7 has been received.

1.	Notifying Member: United States of America
2.	Title of the bilateral or plurilateral Agreement: Agreement on Mutual Recognition Between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice
3.	Parties to the Agreement: Switzerland, United States of America
4.	Date of entry into force of Agreement: 27 July 2023
5.	Products covered (HS or CCCN where applicable, otherwise national tariff heading): Finished pharmaceuticals for human or animal use, intermediates, in-process materials (as defined under U.S. regulations), certain biological products for human use, and active pharmaceutical ingredients
6.	Subject matter covered by the Agreement (technical regulations, standards or conformity assessment procedures): Conformity assessment procedures
7.	Brief description of the Agreement: This agreement facilitates the exchange of official good manufacturing practice documents between the United States and Switzerland and reliance on the factual findings of such documents. The text of the agreement is accessible from the website of the Office of the United States Trade Representative (USTR) at https://ustr.gov/node/12513; US_Switzerland_Pharma_GMP_MRA.pdf.
8.	Further information available from: USA TBT Enquiry Point: usatbtep@nist.gov

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Committee on Technical Barriers to Trade - Agreement reached by a Member with another country or countries on issues related to technical regulations, standards or conformity assessment procedures - Notification - United States of America

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