WTO notification · TBT
ChileUpdated: check whether it is now adopted or in forceEmergency
APPROVES USER INSTRUCTIONS FOR THE SERIALIZATION CONTROL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE AND THEIR ASSOCIATED PROCEDURES, AND REPEALS THE INDICATED RESOLUTION.
APRUEBA INSTRUCTIVO PARA EL USUARIO SOBRE EL CONTROL DE SERIE DE PRODUCTOS FARMACÉUTICOS DE USO HUMANO Y SUS TRÁMITES ASOCIADOS, Y DEJA SIN EFECTO RESOLUCIÓN QUE INDICA.
Chile issued an addendum on 1 September 2026 to the earlier TBT notification G/TBT/N/CHL/800. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 8 July 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Updated here:
Pharmaceutical products for human use
Productos farmacéuticos de uso humano
Latest notice (G/TBT/N/CHL/800/Add.1, 1 September 2026)
Approval of the user guide on the series control of pharmaceutical products for human use and related procedures, and repeal of the Resolution indicated
-__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
In Chile, the series control of pharmaceutical products consists of reviewing manufacturing and control documentation, as well as carrying out analytical evaluations based on risk assessment, for each lot or sublot of a pharmaceutical product before its distribution and use. It is mandatory for biological products and for other pharmaceutical products that, for various reasons, the ISP has decided to subject to such control. It is carried out to ensure quality and safety through independent controls. This process includes the lot release subprocess, which applies to vaccines and blood products, and the biological products control subprocess, which applies to other biological products.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/CHL/800/Add.1
Approval of the user guide on the series control of pharmaceutical products for human use and related procedures, and repeal of the Resolution indicated
-__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
Emergency notificationG/TBT/N/CHL/800Emergency measure
APPROVES USER INSTRUCTIONS FOR THE SERIALIZATION CONTROL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE AND THEIR ASSOCIATED PROCEDURES, AND REPEALS THE INDICATED RESOLUTION.
APRUEBA INSTRUCTIVO PARA EL USUARIO SOBRE EL CONTROL DE SERIE DE PRODUCTOS FARMACÉUTICOS DE USO HUMANO Y SUS TRÁMITES ASOCIADOS, Y DEJA SIN EFECTO RESOLUCIÓN QUE INDICA.
In Chile, the series control of pharmaceutical products consists of reviewing manufacturing and control documentation, as well as carrying out analytical evaluations based on risk assessment, for each lot or sublot of a pharmaceutical product before its distribution and use. It is mandatory for biological products and for other pharmaceutical products that, for various reasons, the ISP has decided to subject to such control. It is carried out to ensure quality and safety through independent controls. This process includes the lot release subprocess, which applies to vaccines and blood products, and the biological products control subprocess, which applies to other biological products.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSProposed measure, open for commentsNew
Chile notified this proposed SPS measure to the WTO on 6 November 2026. Comments are open until 5 January 2027.
Symbol: G/SPS/N/CHL/899Comments until 5 January 2027
WTO notificationSPSIn force, according to its latest noticeNew
Chile issued an addendum on 30 October 2026 to the earlier SPS notification G/SPS/N/CHL/897. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 28 August…
Symbol: G/SPS/N/CHL/897/Add.1
WTO notificationTBTAdopted, according to its latest noticeNew
The notified text establishes the requirements for the National Single Register that manufacturers, formulators, producers, marketers or distributors, packers, importers and exporters of fertilizers and biostimulants must join. It also establishes a classification for fertilizers and biostimulants…
Symbol: G/TBT/N/CHL/586/Add.2Comment period closed
WTO notificationTBTProposed measure, open for commentsNew
Chile notified this proposed TBT measure to the WTO on 21 October 2026. Comments are open until 20 December 2026.
Symbol: G/TBT/N/CHL/807Comments until 20 December 2026
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