Compliance is mandatory as of October 29, 2025, for pharmaceutical products that may affect the ability to operate vehicles and machinery.
On October 29, 2025, Exempt Resolution No. 6,267 of the Public Health Institute (ISP) was published. This resolution approves new requirements regarding the modification of labels and information leaflets for patients and professionals, applicable to pharmaceutical products that may affect the ability to drive vehicles and operate machinery.
The reasons that led the health authority to issue this resolution are mainly related to the influence that the consumption of certain medications could have on the number of deaths from traffic accidents.
In response to this, the ISP, through the National Medicines Agency (ANAMED) and in coordination with the National Traffic Safety Commission (CONASET), considered it necessary to address the situation of medications that affect the ability to drive and operate machinery, incorporating new requirements for labeling and information leaflets.
In this context, applicants for health registrations of pharmaceutical products are instructed that, when submitting their requirements, they must:
- Review, evaluate, report, and declare whether the product qualifies as a medicine that may affect driving ability, using the list issued by the Spanish Agency for Medicines and Health Products (AEMPS) as a reference.
- If the medicinal product is included in the AEMPS list, the pictogram established by the regulation must be included in the labeling design, together with the legend: “Warning: Driving: See leaflet.” The size of the pictogram may be adapted to the packaging, but the side of the triangle may not be less than 10 millimeters.
- Likewise, a warning about the possible impairment of the ability to drive vehicles or operate machinery must be included in the patient and professional information leaflets.
Holders of current health registrations must review and assess whether their products qualify as medicines that may affect the ability to drive or operate machinery. If so, they must incorporate the corresponding pictogram and update the information leaflets.
These modifications must be processed by submitting a request for modification of the health registration to the ISP.
Notwithstanding the foregoing, products in clinical packaging are exempt from this obligation.
Medicines not included in the AEMPS list because they are not registered in Spain, but whose active ingredients or adverse reactions may affect the ability to drive or operate machinery, must also comply with the requirements of the resolution.
Compliance with this regulation is mandatory from October 29, 2025, for new health registration applications. In the case of applications pending at the time of publication, the ISP will request the relevant information.
Holders of already approved registrations will have a period of 36 months to comply with the new requirements and exhaust the stock of previously approved products without the new labeling or leaflet.
Finally, the resolution establishes that, in the event of future modifications to the list of active ingredients—whether by addition or elimination—there will be a 12-month period to adjust compliance with the regulation.
For more information on this new resolution, please contact our Public Law and Regulated Markets group:
Antonio Rubilar | Partner | arubilar@az.cl
Francisco Alarcón | Senior Associate | falarcon@az.cl
Alejandra Bascur | Associate | abascur@az.cl
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