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Kobayashi & Yugeta Law Office > PRACTICE AREAS > Advertising Laws > Pharmaceutical Affairs Law

Pharmaceutical Affairs Law - proposing practical content that does not compromise advertising appeal

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Pharmaceutical Affairs Act") is a law that regulates the manufacture and sale of pharmaceuticals and medical devices, and if you are a company that markets drugs, medical devices, health foods, etc., it is vital for you to be aware of this regulation.

Among the multitude of regulations of the Pharmaceutical Affairs Law, the most important regulations include exaggerated advertisements (Article 66 of the Pharmaceutical Affairs Law) and advertisements for unapproved drugs (Article 68 of the Pharmaceutical Affairs Law). Companies pay considerable attention to the contents, effects and efficacy of the ingredients contained in products although they are limited by what can be included in their advertisements.

However, there are heavy sanctions against violators, such as penalties for violation of Article 66 of the Pharmaceutical Affairs Law (Article 85(iv)), and for violation of Article 68 of the Pharmaceutical and Equipment Law (Article 72-5) and penalties (Article 85(v)).

On the other hand, it is not necessarily clear what constitutes "false or exaggerated articles" nor what "pharmaceuticals" are in terms of regulation of advertising for unapproved drugs, etc., so you need to examine and confirm various administrative notifications, guidelines and self-regulations etc. In other words, the Pharmaceutical Affairs Law is a field of many laws and regulations that need to be researched and reviewed. It requires a great deal of time and effort to study all of these laws and regulations by yourself before starting to manufacture and sell products, since the laws and regulations themselves are complex and difficult to understand.

We have experience and knowledge on what kind of information is allowed in advertisements on websites and product packaging for various products such as health foods, cosmetics and electrical appliances at the request of companies. After clarifying what the problem is and what kind of advertising methods can be used to resolve the problem, we can propose practical content that will not compromise the appeal of your advertisements.