医薬部外品製造販売業許可

医薬部外品製造販売業とは、市場にある製品に対して最終的な責任を負う業者であり、製品の副作用情報、クレーム情報、事故情報等を国内外から積極的に収集し、市販後の製品について安全管理を行うとともに、万が一製品に何らかの問題があると判断された場合は、必要に応じて製品の回収等も行います。また、製造所において、適正な品質管理の下で製品が製造されているか、管理監督する義務もあります。
医薬部外品製造販売業許可は、GMP（医薬品及び医薬部外品の製造管理の基準）が適用される医薬部外品かどうかにより、手数料や申請書類が異なります。
取り扱う品目に関しては、厚生労働大臣又は都道府県知事が承認を行う場合の2種類があります。
この医薬部外品製造販売業許可の専門家が行政書士であり、ご自身で医薬部外品製造販売業許可を行う方が大変とお考えの方は行政書士にご相談されることをお勧めします。

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医薬部外品製造販売業の関係法令
医薬部外品製造販売業の関係法令をご案内しています。

コモンズ行政書士事務所
医薬部外品製造販売業許可を専門としている行政書士事務所です。

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