CDIMAmendment of the Pharmaceutical Machinery Law (Part 6)
This is a column (No. 6) about the revised Pharmaceutical Machinery Law. This time, as a revised matter"Review of regulations on personal imports"I will explain about.
1. Background of amendments
When importing medical products such as pharmaceuticals and medical devices from overseas, in principle, they are imported by companies that have received approval or certification for the products under the Pharmaceutical Machinery Law. However, when used by doctors for the purpose of diagnosing, treating, or preventing diseases, when used for the purpose of clinical trials or experimental research, pharmaceutical products are exhibited for academic research or research and development (advertising is not possible). If you use it for the purpose of exhibiting at such places, or if the general public uses medicines personally (requires a doctor's prescription, etc.), you can import medical products individually. However, personal imports are only permitted when used for specific purposes, and in order to distribute and sell medical products in Japan, approval and permission from the Pharmaceutical Machinery Law must be obtained. ..
In addition, such personal imports may result in the illegal distribution and sale of pharmaceuticals and medical devices, and the risk of counterfeit drugs being distributed in Japan. Therefore, it is necessary to prevent unauthorized, unregistered products, defective products, etc. from illegally flowing into Japan to prevent health hazards. Against this background and purpose, regarding the personal import of medical products, the conventional system called "pharmaceutical supervision certification system" has been used as an administrative notification.＊Was carried out by. (See the figure below)
Drug supervision certification system
"Outline of the bill to revise some of the laws, etc. regarding the assurance of quality/effectiveness and safety of pharmaceuticals/medical devices, etc."
However, it is also true that malicious violations have occurred under this system. For example, an import report (medicine supervision certificate) obtained by an import agency through a false application to use a copy of a doctor's license obtained when importing a doctor in the past without the permission of the person himself / herself. An incident has actually occurred in which an unapproved medical device made by a manufacturer was imported and sold in Japan. Misconduct like this case was criminally charged with fraud (Article 246 of the Penal Code). The reason for this was that it was difficult to impose penalties under the Pharmaceutical Machinery Law for violations because the procedures for personal imports were operated by notification.
Currently, while the number of individual imports of medical products is on the rise, it was difficult for businesses to crack down on violations under the Pharmaceutical Machinery Law, so drugs that were being operated by notification in order to strengthen the crackdown. The supervision certification system has been enacted.
*: Yakusei 1130 No. 1 dated November 30, 2015 "Pharmaceuticals and Poisonous and Deleterious Substances Import Monitoring Guidelines"
2. 2. New system such as regulation on personal import
Due to the background mentioned above, the drug supervision certification system, which was operated by the notification of the Ministry of Health, Labor and Welfare, has been enacted and has become the following new system.
(1) A person who intends to import pharmaceuticals, medical devices, etc. without receiving approval or certification for manufacturing and marketing, or without making a notification, must obtain confirmation from the Minister of Health, Labor and Welfare regarding the import.
However, if you want to import medicines approved in Japan that are less than the quantity specified by the Ordinance of the Ministry of Health, Labor and Welfare (quantity used for medicines, 24 pieces for external preparations, etc.) for your own use, you must be confirmed. I don't need it. In addition, those who have violated the Narcotics and Psychotropics Control Law and the Poisonous and Deleterious Substances Control Law for less than two years cannot receive import confirmation.
As for the procedure, the conventional procedure for notification operation is basically followed.
(2) Regarding the import confirmation procedure, guidance and control will be provided based on the Pharmaceutical Machinery Law, and penalties (imprisonment of up to 3 years, a fine of up to 3 million yen, or both) will be applied to violators. ..
(3) In addition, in order to promptly deal with fraudulent cases such as distribution of unapproved drugs and counterfeit drugs by personal import, regarding counterfeit drugs, there are also drug control officers and drug control officers who are investigators of drug and stimulant crimes. We will crack down on it (with the limitation that it is not for criminal investigation).
As mentioned above, this time, I explained "Review of regulations on personal imports". We will continue to explain each amendment from the next time onwards.
Author: Tokuya Okanouchi
All rights reserved for this column.
Tokuya Okanouchi (CDI Medical Co., Ltd.)
Completed Graduate School of Pharmaceutical Sciences, Shizuoka Prefectural University, Completed Law School at Toin University of Yokohama, and completed Business School at the University of Massachusetts Lowell. Doctor (Pharmacy), Doctor of Law, MBA (Master of Business Administration)
After working at the Ministry of Health, Labor and Welfare, the National Hospital Organization, the Pharmaceuticals and Medical Devices Agency, the National Institute of Health Sciences, the Ministry of the Environment, the Ministry of Justice, and Kanagawa Prefecture.