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Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

  •   4 Dec 2018
  •    Winnie Xu
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    Japan
    • Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

    • Language:EN
    • Format:Electronic Edition (Adobe PDF)
    • Pages:157
    • Translated by: Japanese Law Translation
    • Publish date: 2018-11-21
    • Price: Free

    Details

    This document is the order for enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960). 


    Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2016 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.

    Contents
    Chapter I  General Provisions (Article 1 and Article 1-2)
    Chapter II  Pharmacies (Article 1-3 to Article 2-2)
    Chapter III  Marketing and Manufacturing of Pharmaceuticals, Quasi-Pharmaceutical Products and Cosmetics (Article 3 to Article 35)
    Chapter IV  Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics
    Chapter V  Marketing and Manufacturing of Regenerative Medicine Products (Article 43-2 to Article 43-36)
    Chapter VI  Selling of Pharmaceuticals, Medical Devices, Regenerative Medicine Products (Article 44 to Article 57)
    Chapter VII  Official Verification of Pharmaceuticals (Article 58 to Article 62)
    Chapter VIII  Handling of Pharmaceuticals (Article 63)
    Chapter IX  Advertisement of Pharmaceuticals (Article 64)
    Chapter X  Safety Measures for Pharmaceuticals (Article 64-2 and Article 64-3)
    Chapter XI  Special Provisions for Biological Products (Article 65)
    Chapter XII  Supervision (Article 66 to Article 69)
    Chapter XIII  Designation of Orphan Drugs, Orphan Medical Devices and Orphan Regenerative Medicine Products (Article 70)
    Chapter XIV  Miscellaneous Provisions (Article 70-2 to Article 83)
    Supplementary Provisions