WTO notification · TBT
GuatemalaUpdated: check whether it is now adopted or in force
REGULATION FOR THE SANITARY REGULATION AND CONTROL OF PHARMACEUTICAL PRODUCTS AND RELATED PRODUCTS
REGLAMENTO PARA LA REGULACIÓN Y CONTROL SANITARIO DE LOS PRODUCTOS FARMACÉUTICOS Y AFINES
Guatemala issued an addendum on 30 March 2026 to the earlier TBT notification G/TBT/N/GTM/106. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 11 February 2026. The comment period closed on 12 May 2026.
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Published here:
Updated here:
SAC Code: 30.03 and 30.04 HS Heading SA3003.00 and SA3004.00
Código SAC: 30.03 y 30.04 Partida SA3003.00 y SA3004.00
The comment period closed on 12 May 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/GTM/106/Add.1; it can take them up with Guatemala.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/GTM/106/Add.1, 30 March 2026)
Regulation for the sanitary regulation and control of pharmaceutical and related products (Reglamento para la regulación y control sanitario de los productos farmacéuticos y afines)
Reglamento para la regulación y control sanitario de los productos farmacéuticos y afines (Regulations governing pharmaceutical and related products and health-related controls thereof)
On 11 February 2026, the Government of the Republic of Guatemala notified, in document G/TBT/N/GTM/106, draft regulations governing pharmaceutical and related products and health-related controls thereof.In this regard, WTO Members are advised that the deadline for submitting comments and observations has been extended to 12 May 2026.The text is available online at: 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.G/TBT/N/GTM/106/Add.1- 2 - Agency or authority designated to handle comments:Departamento de Regulación y Control de Productos Farmacéuticos y Afines (Department for the Regulation and Control of Pharmaceutical and Related Products)Tel.: (+502) 2231-2950Email: jefaturadrcpfa@mspas.gob.gt; normativadrcpfa@mspas.gob.gt__________
The purpose of the notified Regulations is to regulate and standardize the control of pharmaceutical and related products; narcotics, psychotropics and their precursors; pesticides for domestic and professional use, of chemical or biological origin, repellents, and the raw materials for these products; the machinery and accessories used to produce and manufacture them; and the establishments that produce and market them.G/TBT/N/GTM/106- 2 - In addition, the Regulations establish the principles, standards, criteria and basic provisions to guarantee the efficacy, safety, performance, proper functioning, and quality of the products mentioned in the previous paragraph throughout their entire life cycle, including from clinical trials through to surveillance, as applicable.The Regulations also set out the actions of natural or legal persons, public or private, national or foreign, related to their involvement in the industrial, commercial or research processes of the products referred to in these Regulations, or who, by virtue of their professional qualifications, may guarantee, control, prescribe or dispense them.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/GTM/106/Add.1
Comment deadline: Closed on 12 May 2026
Regulation for the sanitary regulation and control of pharmaceutical and related products (Reglamento para la regulación y control sanitario de los productos farmacéuticos y afines)
Reglamento para la regulación y control sanitario de los productos farmacéuticos y afines (Regulations governing pharmaceutical and related products and health-related controls thereof)
On 11 February 2026, the Government of the Republic of Guatemala notified, in document G/TBT/N/GTM/106, draft regulations governing pharmaceutical and related products and health-related controls thereof.In this regard, WTO Members are advised that the deadline for submitting comments and observations has been extended to 12 May 2026.The text is available online at: 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.G/TBT/N/GTM/106/Add.1- 2 - Agency or authority designated to handle comments:Departamento de Regulación y Control de Productos Farmacéuticos y Afines (Department for the Regulation and Control of Pharmaceutical and Related Products)Tel.: (+502) 2231-2950Email: jefaturadrcpfa@mspas.gob.gt; normativadrcpfa@mspas.gob.gt__________
Regular notificationG/TBT/N/GTM/106
Comment deadline: Closed on 12 April 2026
REGULATION FOR THE SANITARY REGULATION AND CONTROL OF PHARMACEUTICAL PRODUCTS AND RELATED PRODUCTS
REGLAMENTO PARA LA REGULACIÓN Y CONTROL SANITARIO DE LOS PRODUCTOS FARMACÉUTICOS Y AFINES
The purpose of the notified Regulations is to regulate and standardize the control of pharmaceutical and related products; narcotics, psychotropics and their precursors; pesticides for domestic and professional use, of chemical or biological origin, repellents, and the raw materials for these products; the machinery and accessories used to produce and manufacture them; and the establishments that produce and market them.G/TBT/N/GTM/106- 2 - In addition, the Regulations establish the principles, standards, criteria and basic provisions to guarantee the efficacy, safety, performance, proper functioning, and quality of the products mentioned in the previous paragraph throughout their entire life cycle, including from clinical trials through to surveillance, as applicable.The Regulations also set out the actions of natural or legal persons, public or private, national or foreign, related to their involvement in the industrial, commercial or research processes of the products referred to in these Regulations, or who, by virtue of their professional qualifications, may guarantee, control, prescribe or dispense them.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSEmergency measure, may already applyEmergencyNew
Guatemala notified this emergency SPS measure on 30 January 2026. Emergency measures can apply immediately.
Symbol: G/SPS/N/GTM/77
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