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September 25, 2006

第151話 化粧品の輸入許可

 国内で化粧石鹸を扱うには法令上許可が必要だ。昨年3月までは「化粧品輸入販売業許可証」という資格であったが、現在は「化粧品製造業」及び「化粧品製造販売業」という2種類の許可が必要であり、私の会社でもこの2種の資格を取得している。Photo_4Photo_5


 これらの資格は属人的な要素と言う意味でかなりハードルが高い。“属人的”というのはザックリ言って薬剤師ないしは同等の学歴と経歴を有する者が常勤で品質管理業務に従事していなければならない、と言う部分である。
 他にもGVP,GQPという2種類の品質管理規程を作成し、さらに検査体制を整えた上で立ち入れ検査を受ける。ここで、主として品質管理業務に関して質疑応答があり、チェックされた上で合格なら許可がおりる。私のところでも準備を始めてから許可を戴くまでに3ヶ月半くらいを要した。
 数多くのサイトで“直輸入”と称して石鹸が販売されていて、合法、非合法、玉石混交である。都庁の薬事監視課では非合法の業者や個人については、警告文書を送るだけで、摘発までには至っていないのが実情だそうだが、情報があれば厳正に対処するとも言っていた。

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