JAPAN Law and Practice Contributed by: Shingo Yamada, Yugo Komori, Yasuhiro Akita and Takuma Inoue, Oh-Ebashi LPC & Partners
the recall and the progress thereof. In addition, they are expected to promptly provide recall information to medical institutions and other relevant parties, and to disseminate all recall information using the internet. Road Transport Vehicles Act Automobile manufacturers and other related busi - ness operators must notify the MLIT when they imple - ment recalls in cases where vehicles do not comply with, or are likely to cease complying with, the safety standards for road vehicles and where the cause is deemed to lie in the design or manufacturing process. In addition, when automobile manufacturers or related business operators file a recall notification, they are required to promptly inform the users of the recalled vehicles about the details of the recall through mail, direct visits, or other means. They are also required to publish the notification in the official journal of the Japan Automobile Service Promotion Association and other relevant media, thereby ensuring automo - bile maintenance businesses are also informed of the recall information. Even if vehicles are not in a state of non-compliance with safety standards, automobile manufacturers or related operators may implement an improvement measure where they determine that the vehicle is, or is likely to become, in a condition that cannot be left unaddressed from the standpoint of safety or accident prevention. Finally, in cases that do not fall under a recall or an improvement measure, the automobile manufacturers and related business operators may also implement a measure known as a service campaign. 1.4 Obligations to Notify Regulatory Authorities CPSA Where manufacturers or importers become aware that a serious product incident has occurred in con - nection with the consumer products they manufac - ture or import, they are required to report to the CAA within ten days of becoming aware of the incident: the name and model of the relevant consumer product, the details of the incident, and the quantities manufac - tured or imported and sold. This report must be made in Japanese using the prescribed reporting form. “Serious product incidents” mean product incidents in which serious harm has occurred or may occur, such
as a fatality, serious injury or illness, permanent dis - ability, carbon monoxide poisoning, or fire. In addition, although it is not a legal obligation, the manufacturers or importers are also encouraged to report less serious incidents that do not fall within serious product incidents (“non-serious product inci - dents”) to the National Institute of Technology and Evaluation (NITE). Thus, reporting under the CPSA is accident-based rather than risk-based. Food Sanitation Act Under the FSA, certain food ingredients and substanc - es are designated as those that require special atten - tion from the perspective of preventing public health hazards. Business operators handling foods contain - ing such ingredients or substances must promptly submit a notification to the prefectural governor with - out delay, using the prescribed form, when they obtain information indicating that such foods have caused or may cause harm to human health. Business opera - tors engaged in the manufacture, processing, or sale of food or food additives are under a best-efforts obligation to provide to the prefectural governor or other authority information relating to health hazards attributable to their products (limited to cases where a physician has diagnosed the symptoms as caused by, or suspected to be caused by, the relevant food or additive) and information regarding violations of law. In addition, business operators approved for Food for Specified Health Uses and notifiers of Foods with Function Claims are obliged to collect information on health hazards (as defined above). Furthermore, when they obtain information indicating a risk of occurrence or spread of such health hazards, they must promptly provide that information to the prefectural governor and other relevant authorities. PMDA Marketing authorisation holders are required to report to the MHLW, through the Pharmaceuticals and Medi - cal Devices Agency (PMDA), any adverse reactions or similar events relating to the efficacy and safety of a product where a causal relationship cannot be clearly excluded. Reporting deadlines differ depending on the severity of the adverse reactions or infections and whether they were previously known. The report -
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