Technical Terms

We explain key technical terms of the Pharmaceutical Affairs Law.

Marketing Authorization Holders of Cosmetics

For the purpose of the clarification of responsibility to the market of a company, after-marketing safe organization fullness and strengthening, reservation of international compatibility, etc., "Marketing Authorization Holders of Cosmetics license" was established on the "Pharmaceutical Affairs Law" revision in April 2005, separated from "Manufacture Authorization Holders of Cosmetics license".

Marketing Authorization Holders of Cosmetics is a license which can perform importing and distributing cosmetics in exchange for the market responsibility of the quality aspect of cosmetics or a safety aspect being imposed. This license is required when circulating cosmetics in Japan, regardless of whether cosmetics are domestic or overseas products, and self-manufacture or third-party products. (License expires in 5 years.)

By Marketing Authorization Holders of Cosmetics have been specified, the locus of the responsibility in the quality and the safety of cosmetics was clarified.

Application Requirements for Marketing Authorization Holders of Cosmetics

  • Arrangement of sufficient staff.
  • Arrangement of the person responsible for safety management.
  • Implementation of safety management duties.
  • Arrangement of a general manufacturing-and-selling person in charge.
  • Creating quality control operating procedures.
  • Documents and records management.
  • Arrangement of the person responsible for quality assurance.
  • Implementation of quality management duties.
  • Establish systems to provide information to consumers.
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GQP・GVP

GQP is the abbreviation for Good Quality Practice, and means a manufacturing-and-selling quality assurance standard. The official name is called "ministerial ordinance about the standard of quality control of medical supplies, quasi-drugs, cosmetics, and medical equipment." Maintaining the suitable business organization at the time of shipping a product to a market and having managed the manual appropriately are defined.

  • Appointment of the person responsible for quality assurance.
  • Treatment such as poor quality information and quality, etc.
  • Work of the person responsible for quality assurance and the person responsible for overall manufacturing and sales.
  • Recall procedure.
  • Creating quality control operating procedures.
  • Documents and records management.
  • Creating records of distribution marketing.
  • Quality management practices required for the other.
  • Ensuring appropriate production management and quality control.

GVP is the abbreviation for Good Vigilance Practice, and means the safety standards after manufacturing and selling. The official name is called "ministerial ordinance about the standard of the safety control after manufacturing and selling of medical supplies, quasi-drugs, cosmetics, and medical equipment." The safety control information about the product currently supplied to the market is collected, and taking a required measure is defined.

  • Appointment of the person responsible for quality assurance.
  • Work of the person responsible for quality assurance and the person responsible for overall manufacturing and sales.
  • Creation and recording of safety management procedures.
  • Collection of information safety management.
  • Planning of security measures based on the results of the review of information security management.
  • Implementation of a security measure.
  • The organization and the personnel concerning security works.
  • Creation of a safety control operating manual.(It is not essential on cosmetics, but it is necessary substantially.)
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Standards for Cosmetics
(Ministry of Health and Welfare Notification No.331 of 2000)

April 2001, it is specified that "Prohibition of inclusion of ingredients other than preservatives, UV absorbers and tar colors, which is called negative list", and "Limitation on inclusion of ingredients other than preservatives, UV absorbers and tar colors, which is called positive list" as the cosmetics standard. About the ingredient which does not violate the provisions of the standard cosmetic, it is permitted to incorporate in cosmetics after checking and choosing safety under corporate responsibility.

Ingredients Class Ingredients
Prohibition of inclusion Other than preservatives, UV absorbers and tar colors Refer to the appendix 1 of page3.
Limitation on inclusion Other than preservatives, UV absorbers and tar colors Refer to the appendix 2 of page4.
Preservatives Refer to the appendix 3 of page5.
UV absorbers Refer to the appendix 4 of page7.
Other than tar colors Shall apply the provisions of Article 3 of the ministerial ordinance to specify the tar colors that can be used for medical supplies, which is No. 30 of the Ordinance of the Ministry of Health and Welfare 1966.
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Cosmetics Legally Designated Item

Cosmetics legally designated item (Article 61 of Pharmaceutical Affairs Law)

No. Item Description
1 Name and address of primary distributor Corporation name
Address of the office where a general manufacture person in charge performs the business.
2 Brand name Name for which notification has been posted for primary distribution.
3 Manufacturing number or code
4 List of ingredients Principle, all ingredient names.
5 Expiration date 1. Cosmetics containing ascorbic acid, its ester, those salts, or oxygen.
2. In addition to 1. , Cosmetics which have a possibility that nature and quality may change within three years, under relevant preservation conditions after manufacture or import.
6 In cosmetic criteria have been established pursuant to the provisions of Paragraph 2 of Article 42 of the Pharmaceutical Affairs Law, the matters set forth as described in the reference directly to the container or encapsulation in that criteria.
7 Names, such as a foreign exceptional approved person etc. It restricts to the cosmetics which received recognition by the regulation of 2 of Article 19 of the Pharmaceutical Affairs Law.
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Ingredients Label Name of Cosmetics

Ingredients of cosmetics are listed in the Standard INCI name, which is the international cosmetic ingredient name The Personal Care Products Council has released.

Ingredient labeling in Japan have to follow the view of the Japanese name that corresponds to the INCI name of the Japan Cosmetic Industry Association creates.

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