<p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">為進(jìn)一步規(guī)范保健食品市場經(jīng)營秩序，杜絕保健食品經(jīng)營企業(yè)混亂經(jīng)營保健食品現(xiàn)象，確保保健食品經(jīng)營企業(yè)朝著健康軌道發(fā)展，根據(jù)《中華人民共和國食品安全法》及《中華人民共和國食品安全法實(shí)施條例》、《保健食品管理辦法》等國家相關(guān)法律法規(guī)，保健食品經(jīng)營企業(yè)應(yīng)規(guī)范保健食品經(jīng)營管理，具體要求如下：<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">一、藥品經(jīng)營企業(yè)經(jīng)營保健食品的要求：<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">1</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、三年內(nèi)不存在藥品<span lang="EN-US">GSP</span>管理缺陷問題的藥品經(jīng)營企業(yè)，允許申請辦理《河北省保健食品經(jīng)營企業(yè)審核意見表》后繼續(xù)經(jīng)營保健食品。<span lang="EN-US">(</span>此款由我局藥管科出具證明<span lang="EN-US">)<o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">2</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、一年內(nèi)無群眾舉報投訴事件，無保健食品冒充藥品銷售等違法行為的藥品經(jīng)營企業(yè)，允許在《衛(wèi)生許可證》到期后申請辦理《保健食品經(jīng)營企業(yè)審核意見表》，繼續(xù)經(jīng)營保健食品。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">3</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、<span lang="EN-US">2012</span>年以前開辦的藥品經(jīng)營企業(yè)，有有效《衛(wèi)生許可證》或《保健食品經(jīng)營企業(yè)審核意見表》的，允許經(jīng)營保健食品；沒有《衛(wèi)生許可證》或《保健食品經(jīng)營企業(yè)審核意見表》，符合上述兩個條款要求的，必須在<!--?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /--><st1:chsdate w:st="on" year="2012" month="5" day="31" islunardate="False" isrocdate="False"><span lang="EN-US">2012</span>年<span lang="EN-US">5</span>月<span lang="EN-US">31</span>日</st1:chsdate>之前辦理《保健食品經(jīng)營企業(yè)審核意見表》；未辦理或不合格的企業(yè)，不允許經(jīng)營保健食品。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">二、保健食品</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">經(jīng)營企業(yè)<span style="mso-bidi-font-weight: bold">管理要求：</span><span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體" lang="EN-US">1</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">、保健食品經(jīng)營企業(yè)必須取得《保健食品經(jīng)營審核意見表》后方可經(jīng)營保健食品。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">2</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、遠(yuǎn)離污染源，距離暴露垃圾堆（場）、坑式廁所、糞池<st1:chmetcnv w:st="on" tcsc="0" numbertype="1" negative="False" hasspace="False" sourcevalue="25" unitname="米"><st1:chsdate w:st="on" tcsc="0" numbertype="1" negative="False" hasspace="False" sourcevalue="25" unitname="米"><span lang="EN-US">25</span>米</st1:chsdate></st1:chmetcnv>以上，環(huán)境整潔，地面以耐磨防滑、不滲水、易清潔材料鋪設(shè)，墻壁采用淺色、無毒、不滲水、不易脫落材料覆涂，天花板用不易脫落、易清潔材料。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">3</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、有符合經(jīng)營規(guī)模的庫房，保健食品存放設(shè)專門區(qū)域，不得與有毒有害物品同庫存放；經(jīng)營場所和庫房應(yīng)配備紗門、紗窗或者門簾，木門下端裝有金屬防鼠板，下水道出口處有金屬隔柵；庫房設(shè)隔離地面的平臺和層架并有機(jī)械通風(fēng)設(shè)施。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體" lang="EN-US">4</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">、</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">設(shè)立從業(yè)人員更衣設(shè)施，有洗手消毒設(shè)施，廁所為水沖式，有洗手設(shè)施，場所設(shè)置密閉的廢棄物盛放容器。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">5</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、<span style="mso-bidi-font-weight: bold">藥品經(jīng)營企業(yè)經(jīng)營保健食品，</span>不可占用原審批的藥品、醫(yī)療器械經(jīng)營及倉儲面積；，經(jīng)營場所<span style="mso-bidi-font-weight: bold">須設(shè)立保健食品專區(qū)或?qū)９瘢?lt;/span>明顯懸掛保健食品標(biāo)識；并有獨(dú)立的倉儲區(qū)域，不得與其他物品混放。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體" lang="EN-US">6</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">、</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">經(jīng)營企業(yè)負(fù)責(zé)人為保健食品安全第一責(zé)任人，有保健食品安全管理機(jī)構(gòu)，有專兼職保健食品安全管理人員，職責(zé)明確，從業(yè)人員須<span lang="EN-US">2</span>人以上，持健康證和保健食品知識培訓(xùn)合格證上崗。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">7</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、建立健全的安全管理制度：崗位責(zé)任制度、監(jiān)督檔案管理制度、索證制度、退換貨制度、保健食品安全知識培訓(xùn)考核制度、從業(yè)人員健康檢查制度、從業(yè)人員健康檔案管理制度、進(jìn)貨查驗(yàn)記錄制度、保健食品安全檔案管理制度、銷售記錄管理制度、假冒偽劣保健食品報告制度等。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">8</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、建立保健食品法律法規(guī)文件檔案、監(jiān)督檔案、從業(yè)人員健康檔案、保健食品索證檔案、進(jìn)貨查驗(yàn)記錄檔案、保健食品安全知識培訓(xùn)檔案等。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US">9</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">、<span style="mso-bidi-font-weight: bold">保健食品經(jīng)營企業(yè)必須索取加蓋供貨單位公章的保健食品批件復(fù)印件、保健食品生產(chǎn)企業(yè)生產(chǎn)許可證復(fù)印件、保健食品供貨單位營業(yè)執(zhí)照、經(jīng)營許可證復(fù)印件、</span>產(chǎn)品檢驗(yàn)合格證或產(chǎn)品質(zhì)量檢驗(yàn)報告<span style="mso-bidi-font-weight: bold">、供貨單位開具的合法隨貨票據(jù)；嚴(yán)格執(zhí)行進(jìn)貨查驗(yàn)制度，要有專兼職保健食品進(jìn)貨驗(yàn)收員并建立進(jìn)貨查驗(yàn)記錄，欄目包括產(chǎn)品名稱、規(guī)格、數(shù)量、進(jìn)貨時間、供貨商、聯(lián)系電話、生產(chǎn)日期或批號、保質(zhì)期限、保存條件、驗(yàn)收情況、驗(yàn)收人簽名；有出庫記錄。<span lang="EN-US"><o:p></o:p></span></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">三、保健食品銷售管理要求：<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">不允許保健食品經(jīng)營企業(yè)異地銷售保健食品，如<span lang="EN-US">XX</span>保健食品店的實(shí)際位置在遷安市新穎路，就不允許其在電影院或其它地方搞保健食品經(jīng)營銷售活動；不允許出租柜臺、出借保健食品經(jīng)營許可證；不允許</span><span style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt">保健食品在其廣告、宣傳材料中宣稱疾病預(yù)防治療功能、以專家或患者名義進(jìn)行功效證明等虛假宣傳；不允許普通食品通過包裝、標(biāo)簽、說明書等宣稱具有特定保健功能的行為。</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體" lang="EN-US"><o:p></o:p></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="left"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">四、遷安市食品藥品監(jiān)督管理局將加大對無證銷售保健食品、日常管理不規(guī)范、經(jīng)營假冒保健食品等違法違規(guī)行為的打擊力度，依法嚴(yán)肅查處違法行為。對未按規(guī)定建立索證索票、進(jìn)貨查驗(yàn)制度導(dǎo)致無法追溯產(chǎn)品源頭的，一律依法嚴(yán)格處罰；情節(jié)嚴(yán)重的，責(zé)令停業(yè)整頓，<span style="mso-bidi-font-weight: bold">直至吊銷許可證；構(gòu)成犯罪的，及時移送司法部門</span>。<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="left"><span style="FONT-FAMILY: 宋體; FONT-SIZE: 16pt" lang="EN-US"><o:p> </o:p></span></p> <p style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="left"><span style="FONT-FAMILY: 宋體; FONT-SIZE: 16pt" lang="EN-US"><o:p> </o:p></span></p> <p style="TEXT-ALIGN: right; LINE-HEIGHT: 30pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="right"><span style="FONT-FAMILY: 宋體; FONT-SIZE: 16pt" lang="EN-US"><span style="mso-spacerun: yes">                </span><span style="mso-spacerun: yes">       </span></span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體" lang="EN-US"><span style="mso-spacerun: yes"> </span></span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋體">遷安市食品藥品監(jiān)督管理局<span lang="EN-US"><o:p></o:p></span></span></p> <p style="TEXT-ALIGN: right; LINE-HEIGHT: 30pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0" class="MsoNormal" align="right"><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">二</span><span style="FONT-FAMILY: 宋體; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-ascii-font-family: 仿宋_GB2312">〇</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-hansi-font-family: 宋體">一二年二月十五日</span><span style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt" lang="EN-US"><o:p></o:p></span></p>