In February, Japanese authority MHLW (Ministry of Health, Labour and Welfare) has announced two further changes in pharmaceutical quality regulations.
- Packaging inserts in the product package will not be mandatory (abolished), but you must make appropriate product information available through scannable GS-1 code. There has been a long discussion whether to mandate the code as GS-1 or QR, but the decision is now to require GS-1.
- The Marketing authorization holder must assign a pharmacist to act as a marketing supervisor-general (somewhat like the EU “Qualified Person”), responsible for quality and safety issues of company products, but in the event that such a pharmacist is not available in the company, the company may have another person serve as a marketing-supervisor-general for up to 5 years. The company, however, is requested to hire a pharmacist and to have a training schedule leading that individual to become the marketing supervisor-general.
These changes become effective from August 1, 2021.