Cosmetics and Quasi-Drugs: What’s the Difference?
Many products which are classified as cosmetics in other countries are treated as quasi-drugs in Japan. This tends to depend on their component parts, ingredients or effects, and is perhaps best understood through use of example.Examples of Cosmetics | Examples of Quasi-Drugs |
Face cream, toner, lipstick, foundation, manicure products, gel nails, shampoo, condition, soap, body moisturizer, bath salts, facemasks, perfume | Medicinal cosmetics, medicinal toothpaste, antibacterial/disinfectant products, antiperspirants, hair dye, perm agents, medicinal bath salts, adhesive plasters, sanitary products |
What Permit Do I Need?
For both cosmetics and quasi-drugs, the permit you need will be determined by the type of business activities you wish to carry out.Business Activities | Permit(s) | |
Selling products under your own brand name | Manufacturing and Sale Permit | |
Manufacturing products (incl. packaging, labeling and storage) | Manufacturing Permit | General Permit ・All activities involved with the manufacture of goods |
Packaging and Related Activities Permit ・Packaging, labeling and storage only |
Basic Requirements

Manufacturing and Sale
In order to engage in the manufacture and/or sale of either Cosmetics or Quasi-Drugs, you will need GQP (Good Quality Practice) and GVP (Good Vigilance Practice) instruction manuals which meet standards set by the Ministry of Health, Labor and Welfare. Preparation of these documents comes under our support service.Management Requirements
① Cosmetics You must employ a manager* who holds at least one of the following qualifications. Whether your qualifications are Japanese or non-Japanese, please in touch to find out whether they are valid for this business license.- Pharmacist
- Completion of a course in medicine or chemistry at college, university or other similar level of education
- Specialism in medicine or chemistry at high school or similar level of education followed by 3 years or more of supervising the safe handling and sale of cosmetics, quasi-drugs or other medical goods
- Possession of skills or qualification equal or superior to those mentioned above, with recognition from Japan’s Minister for Health, Labor and Welfare
- Pharmacist
- Completion of a course in medicine or chemistry at university or a similar level of education
- Specialism in medicine or chemistry at high school or similar level of education followed by 3 years or more of supervising the safe handling and sale of cosmetics, quasi-drugs or other medical goods
- Possession of skills or qualification equal or superior to those mentioned above, with recognition from Japan’s Minister for Health, Labor and Welfare
Manufacturing
General Requirements
- The manufactured products can only be distributed by the consignor or the consigned manufacturer (actual supplier)
- Equipment and facilities which meet standards defined by the Ministry of Health, Labor and Welfare
Management Requirements
① Cosmetics You must employ a manager who holds at least one of the following qualifications.- Pharmacist
- Completion of a course in medicine or chemistry at college, university or other similar level of education
- Specialism in medicine or chemistry at high school or similar level of education followed by 3 years or more of supervising the safe handling and sale of cosmetics, quasi-drugs or other medical goods
- Possession of skills or qualification equal or superior to those mentioned above, with recognition from Japan’s Minister for Health, Labor and Welfare
- Pharmacist
- Completion of a course in medicine or chemistry at university or a similar level of education
- Specialism in medicine or chemistry at high school or similar level of education followed by 3 years or more of supervising the safe handling and sale of cosmetics, quasi-drugs or other medical goods
- Possession of skills or qualification equal or superior to those mentioned above, with recognition from Japan’s Minister for Health, Labor and Welfare
*Exclusion Criteria*
The following apply to both of the above permits.- The applicant or the board of directors of the company has had a cosmetics or quasi-drugs license withdrawn within the past 3 years
- The applicant or the board of directors of the company has been sentenced to imprisonment within the past 3 years
- The applicant or the board of directors of the company has committed a drug offence or any similar offence within the past 2 years;
- The applicant or the board of directors of the company has been judged psychologically unfit to carry out business to the necessary standard
Contact Us
For any further questions about Japan’s cosmetics and quasi-drug industries or about how to establish your cosmetics or quasi-drugs business, please do not hesitate to contact us!
