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《藥事管理與法規》 藥品廣告如何管理

陕西省快乐十分派彩电子走势图 www.gkvzj.com 2015-10-5 09:04| 發布者: 中藥材| 查看: 7046| 評論: 42|來自: 21世紀藥店

摘要: 2015年上半年,國家食藥監部門累計監測發現嚴重違法廣告37萬條,各地食藥監部門向社會發布違法廣告58期,曝光嚴重違法廣告藥品493個、保健食品179個;撤銷或收回廣告批準文號52個,采取產品暫停銷售41次。藥品的廣告 ...

2015年上半年,國家食藥監部門累計監測發現嚴重違法廣告37萬條,各地食藥監部門向社會發布違法廣告58期,曝光嚴重違法廣告藥品493個、保健食品179個;撤銷或收回廣告批準文號52個,采取產品暫停銷售41次。

 

藥品的廣告管理是執業藥師必備的知識,也是執業藥師考試的考點之一,在考試中大概占34分。現將其考點整理如右:

 

藥品廣告的審批

 

藥品廣告須經企業所在地省、自治區、直轄市人民政府食品藥品監督管理部門批準,并發給藥品廣告批準文號;未取得藥品廣告批準文號的,不得發布。

 

藥品廣告的審查

 

凡利用各種媒介或者形式發布的含有藥品名稱、藥品適應癥(功能主治)或者與藥品有關的其他內容的,為藥品廣告,應當依法進行審査。

 

藥品廣告的發布

 

******品、精神藥品、醫療用毒性藥品、放射性藥品,醫療機構配制的制劑,軍隊特需藥品,國家食品藥品監督管理總局依法明令停止或者禁止生產、銷售和使用的藥品,批準試生產的藥品不得發布廣告。

 

處方藥可以在國務院衛生行政部門和國務院藥品監督管理部門共同指定的醫學、藥學專業刊物上介紹,但不得在大眾傳播媒介發布廣告或者以其他方式進行以公眾為對象的廣告宣傳,不得以贈送醫學、藥學專業刊物等形式向公眾發布處方藥廣告,不得在未成年人出版物和廣播電視頻道、節目、欄目上發布。非處方藥廣告發布的媒體沒有限制。

 

藥品廣告的內容

 

1.藥品廣告的內容必須真實、合法,以國務院食品藥品監督管理部門批準的說明書為準,不得含有虛假的內容,不得進行擴大或者惡意隱瞞的宣傳,不得含有說明書以外的理論、觀點等內容。

 

2.藥品廣告中必須標明藥品的通用名稱、忠告語、藥品廣告批準文號、藥品生產批準文號、藥品生產企業或者藥品經營企業名稱;非處方藥廣告必須同時標明非處方藥專用標識(OTC)。

 

3.以非處方藥商品名稱為各種活動冠名的,可以只發布藥品商品名稱。

 

4.藥品廣告不得單獨出現“咨詢熱線”、“咨詢電話”等內容。

 

5.處方藥廣告的忠告語是:“本廣告僅供醫學藥學專業人士閱讀”。非處方藥廣告的忠告語是:“請按藥品說明書或在藥師指導下購買和使用”。

 

6.藥品廣告中有關藥品功能療效的宣傳應當科學準確,不得出現下列情形:不科學地表示功效的斷言或者保證的;利用國家機關、醫藥科研單位、學術機構或者專家、學者、醫師、患者的名義和形象作證明;說明治愈率或者有效率的;與其他藥品的功效和安全性進行比較的;違反科學規律,明示或者暗示包治百病、適應所有癥狀的;含有“安全無毒副作用”、“毒副作用小”等內容的;含有明示或者暗示中成藥為“天然”藥品,因而安全性有保證等內容的。

 

7.藥品廣告不得含有軍隊單位或者軍隊人員的名義、形象。不得利用軍隊裝備、設施從事藥品廣告宣傳。

 

8.藥品廣告不得含有醫療機構的名稱、地址、聯系辦法、診療項目、診療方法以及有關義診、醫療(熱線)咨詢、開設特約門診等醫療服務的內容。


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