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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

If you are not sure of which permit you will need for your business, you may even need both of the above. In order to sell goods imported to Japan, for example, both a Manufacturing and Sale Permit and a Manufacturing (Packaging and Related Activities) Permit are necessary. 

One feature of cosmetics and quasi-drugs permits in Japan is that products for which the manufacturer and distributor (the company with a Manufacturing and Sale Permit) has not made decisions regarding shipping can only be held by a company with a Manufacturing Permit. If said company does not take any actions which expose the contents of the goods to the open air, a Packaging and Related Activities Permit will be sufficient for their activities. For example, when importing products to Japan from overseas, these products can first be held by a company holding a Manufacturing Permit. Goods will then be shipped and sold only when a company holding a Manufacturing and Sale Permit gives its approval – i.e. any goods which are yet to gain this approval must stay with the company with just the Manufacturing Permit.

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Basic Requirements

The following describes the basic requirements that must be fulfilled to acquire permits for the manufacture and/or sale of cosmetics or quasi-drugs in Japan.

As the requirements regarding the manager of the manufacture and/or sale of your goods are slightly different for cosmetics and quasi-drugs, they are introduced separately below. However, for both cosmetics and quasi-drugs, we strongly recommend that the person in charge have a high level of Japanese language ability. This is because upon acquiring a permit, periodic inspections are carried out by local authorities to check compliance with regulations, and these inspections will be carried out in Japanese.

N.B. These are general requirements and do not necessarily reflect the reality of what may be needed for your specific application.

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

*N.B. Should you wish to carry out business in more than one location in Japan, you may need multiple managers. 

② Quasi-Drugs

You must employ a manager who holds at least one of the following qualifications.

  • 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

② Quasi-Drugs

You must employ a manager who holds at least one of the following qualifications.

  • 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.

  1. The applicant or the board of directors of the company has had a cosmetics or quasi-drugs license withdrawn within the past 3 years
  2. The applicant or the board of directors of the company has been sentenced to imprisonment within the past 3 years
  3. The applicant or the board of directors of the company has committed a drug offence or any similar offence within the past 2 years;
  4. The applicant or the board of directors of the company has been judged psychologically unfit to carry out business to the necessary standard

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!

 

*Please be aware that the contents of this site are naturally subject to change, meaning that we cannot guarantee their accuracy at the point of access.*
*For up-to-date information, please contact us directly.*  

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