إجراء طارئ من تشيلي: المركبات

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…