Last Updated June 11, 2019

Law and Practice

Contributed By Jones Day

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

Advertising Prescription-only Medicines

Advertising prescription-only medicines to the general public is prohibited in Japan. Article 5 (1) of the Standards expressly prohibits such advertising. In addition, Article 67 (1) of the PMD Act prohibits advertising drugs for specified diseases and regenerative medicines to the general public.

Advertising Over-the-counter Medicines

Advertising OTC medicines to the general public is not prohibited but is restricted by the PMD Act and the Standards, as well as by self-regulatory codes.

Advertising for OTC medicines is subject to the rules concerning advertising under the PMD Act and the Standards, which are described above in Section 1. In this regard, it should be noted that Article 6 of the Standards stipulates a particular restriction on advertisements to the general public concerning the efficacy of drugs for diseases, which cannot be expected to be cured without a doctor’s or dentist’s diagnosis or treatment. This Article provides that such advertisements must not suggest that the diseases can be cured without such a diagnosis or treatment when the advertisements are targeted at the general public.

In addition, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of the publicity and advertising activities for non-prescription drugs.

Jones Day

Kamiyacho Prime Place
1-17, Toranomon 4-chome
Minato-ku
Tokyo 105-0001
Japan

+81 334333939

+81 354012725

www.jonesday.com/tokyo/

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

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