Quasi-Drugs Other

The new regulations (after 25th Dec, 2014) can be summarized as follows.

Application Procedures (Agency service is available.)

  1. Application to positive list

  2. Application to change from cosmetics to quasi-drug

  3. Issuance of Yakkan certificate

  4. Application for approval and verification

Manual Documentation (Simplified procedure service is available.)

  1. Documentation of GVP manual for quasi-drug

  2. Documentation of GOP manual for quasi-drug

  3. Documentation of GMP manual for quasi-drug

Consultation Services

  1. Consultation on new quasi-drug

  2. Consultation on documentation of HP in compliance with pharmaceutical law

  3. Consultation on documentation of product standards or quality standards

Investigation

  1. Investigation of quasi-drug ingredients (determine whether appropriate ingredients are used)

  2. Investigation of GQP of foreign manufacturing (field investigation)

  3. Investigation of analysis on quasi-drug ingredients

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03-6264-3883
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03-4586-7032
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