Chapter 1 Japan MHLW Regulatory information brief

1. Eaa and Introduction

Cosmetics in Japan are licensed under the Pharmaceutical Affairs Act (PAL) by the Ministry of Health, Labour and Welfare. MHLW) to regulate. A series of auxiliary rules, standards and guidance documents issued by the Ministry of Health, Labour and Welfare support the cosmetics industry.

The Medicines and Medical Devices Agency (PMDA) conducts on-site and documentation reviews to evaluate reports of adverse reactions and to review applications from foreign manufacturers and importers.

Each prefectural government is responsible for licensing, inspection and guidance.

2. Supervision and regulation

Pharmaceutical and Medical Device Law (the “PMDL”), formerly known as the Pharmaceutical Affairs Law (the PAL) .

3. Japanese cosmetics definition 

Pharmaceutical Affairs Law, PAL A cosmetic is defined as follows: "Cosmetic" means a substance used by the body to cleanse, beautify, increase attractiveness and improve appearance, intended for use by rubbing, spraying or other similar methods. Substances for the purposes specified in Paragraph 1, No. 2 or No. 3 (Pharmaceuticals), and non-pharmaceutical products are excluded.

Products with special efficacy such as deodorant, hair removal agent, hair growth treatment agent, as well as sterilization, disinfection, whitening and other products belong to the pharmaceutical department and belong to the PMDA supervision.

4. Entry requirement

• Japan Importer Details (with a valid cosmetic manufacturing and sales license)

• Power of attorney

• Cosmetics quality management system related documents、Cosmetics production and sales after the safety management system related documents

• Manufacturer details

• Basic product information and efficacy claims、Complete composition list、tag
  

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5. Registration language 

Japanese

Chapter 2 Registration process, cycle & Government fee

1. Registration process

Foreign manufacturer certification process：

Product classification-->Importer information confirmation and qualification review-->Ingredient & Label audit-->Foreign cosmetics manufacturer certification-->Product information notice

2. Registrar's fee

Chapter 3 FAQ 

Q：How long is the validity of the certificate of foreign manufacturer of cosmetics?

A: The Cabinet order provides for a period of five years, Article 17 mutatis mutandis of the law applicable to Article 13, paragraph 3, paragraph 3 of the law (including where Article 13, paragraph 3, paragraph 9 of the law applies mutatis mutandis).

Q：Can foreign manufacturer certificates be renewed when they expire? How to operate?

A: An "accredited foreign manufacturer" will not be valid unless its accreditation is renewed within its 5-year validity period using an "Application for Renewal of Accreditation" (Form 20 in the PAL Enforcement Regulations). When renewing an approved organization, they are also required to submit an "Application for Accreditation Examination" form (REG. 16-(2)) in accordance with the new application referred to in paragraph 2-(1) above.

When "recognized foreign manufacturers" apply for the first renewal of their recognized recognition after the PAL amendments, they will need to attach a copy of the import license certificate granted under the old PAL to their Japanese importer, the marketing approval holder under the new PAL, in addition to following the same procedure to obtain the new certification. On the other hand, "recognized foreign manufacturers" who wish to renew their recognition under the new HKAS are required to attach their certificate of recognition to the renewal application form.