WTO notification · TBT
ChileEmergency measure, may already applyEmergency
APPROVES REQUIREMENTS FOR THE MODIFICATION OF LABELS AND PATIENT AND PROFESSIONAL INFORMATION LEAFLETS FOR PHARMACEUTICAL PRODUCTS WITH EFFECTS ON THE ABILITY TO DRIVE VEHICLES AND OPERATE MACHINERY.
APRUEBA EXIGENCIAS DE MODIFICACIÓN DE RÓTULO Y FOLLETOS DE INFORMACIÓN AL PACIENTE Y AL PROFESIONAL PARA PRODUCTOS FARMACÉUTICOS CON EFECTOS SOBRE LA CAPACIDAD DE CONDUCIR VEHÍCULOS Y OPERAR MAQUINARIAS.
Chile notified this emergency TBT measure on 3 December 2025. Emergency measures can apply immediately.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Pharmaceutical Products
Productos Farmacéuticos
The notification sets no comment deadline. To comment, contact your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CHL/763; it forwards comments to Chile.
Find your country's enquiry point on WTO ePing (opens in a new tab)The notified resolution responds to a critical and immediate public health imperative. As is widely known, road accidents in Chile claim, on average, 2,000 lives a year. The technical work carried out together with the National Traffic Safety Commission (CONASET) highlighted the urgent need to draw attention to the effects of certain medicines on the ability to drive, given that the use of substances and fatigue are important factors in fatal road accidents.The regulations adhere to the classification and list of active ingredients of the Spanish Agency for Medicines and Medical Devices (AEMPS) and the findings of the European Driving Under the Influence of Drugs, Alcohol and Medicines (DRUID) project. By aligning the regulations with an already validated European standard, we seek to harmonize our requirements with high-standard regulations, thereby reducing technical uncertainty for those covered by those regulations.G/TBT/N/CHL/763- 2 - Applicants seeking to register pharmaceutical products in the health register shall be required, when entering their specifications, to comply with the following guidelines:(a) To revise, evaluate, report and declare whether the product subject to the health registration procedure, regardless of its classification, qualifies as a pharmaceutical product that may affect the ability to drive.To this end, the reference list issued by AEMPS shall serve as a comparator. This list is available free of charge from the AEMPS website: Once the…
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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Expodite matches each notification to the markets you export to and the HS codes of your products, and puts the ones that concern you in your Updates centre, with the date comments close.