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WTO notification · TBT

ChileAdopted, according to its latest notice

Pharmaceutical products – Chile

Water for pharmaceutical use: Guide for its sanitary registration and requirements for oral antibiotics.

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Agua para uso farmacéutico: Guía para su registro sanitario y exigencias para antibióticos de uso oral.

Chile issued an addendum on 17 September 2026 to the earlier TBT notification G/TBT/N/CHL/792. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 8 May 2026. The comment period closed on 7 July 2026.

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At a glance

Products

Pharmaceutical Products

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Productos Farmacéuticos

Notifying member
Chile
Status
Adopted, according to its latest notice
Objectives
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CHL/792Latest notice: G/TBT/N/CHL/792/Add.1
ICS classification
  • 11.120.10 Medicaments
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 7 July 2026
Proposed adoption
The measure is mandatory for all new applications for registration of oral antibiotics in powder or granulated form submitted to the ISP from the date of its publication in the Official Journal.G/TBT/
Proposed entry into force
La medida es obligatoria para toda nueva solicitud de registro de un antibiótico en forma de polvo o granulado de uso oral que se presente ante el ISP a partir de su publicación en el Diario Oficial.

What the notification says

Latest notice (⁨G/TBT/N/CHL/792/Add.1⁩, 17 September 2026)

The latest notice says the measure was adopted or published.

Water for pharmaceutical use: Guidance for sanitary registration and requirements for oral antibiotics

The Republic of Chile hereby advises that Exempt Resolution No. 4.235 of 21 August 2026, approving 'Water for pharmaceutical use: Guidance for sanitary registration and requirements for oral antibiotics', has been published.__________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.

The guidance issued by the Public Health Institute (ISP) establishes updated requirements for the sanitary registration of water for pharmaceutical use and sets out new requirements for orally administered antibiotics. The document aims to prevent risks of intoxication, contamination, and treatment inefficacy arising from improper reconstitution at home, requiring that all new registration requests for oral antibiotics in powder or granulated form include the necessary solvent as a combination product registration. It also classifies the various types of water and details their quality standards and intended uses in accordance with national and international regulations.

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/CHL/792/Add.1

    Water for pharmaceutical use: Guidance for sanitary registration and requirements for oral antibiotics

    The Republic of Chile hereby advises that Exempt Resolution No. 4.235 of 21 August 2026, approving 'Water for pharmaceutical use: Guidance for sanitary registration and requirements for oral antibiotics', has been published.__________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.

  2. Regular notificationG/TBT/N/CHL/792

    Comment deadline: Closed on 7 July 2026

    Water for pharmaceutical use: Guide for its sanitary registration and requirements for oral antibiotics.

    View original

    Agua para uso farmacéutico: Guía para su registro sanitario y exigencias para antibióticos de uso oral.

    The guidance issued by the Public Health Institute (ISP) establishes updated requirements for the sanitary registration of water for pharmaceutical use and sets out new requirements for orally administered antibiotics. The document aims to prevent risks of intoxication, contamination, and treatment inefficacy arising from improper reconstitution at home, requiring that all new registration requests for oral antibiotics in powder or granulated form include the necessary solvent as a combination product registration. It also classifies the various types of water and details their quality standards and intended uses in accordance with national and international regulations.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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