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This application is a service of the Singapore Government.

Health Sciences Authority

Labelling Requirements and Prohibited Claims 标签及宣称的要求

Full labelling in English is required for all CPM. Chinese or other languages, if any, may be used in addition to English. The information in languages other than Chinese and English, if applicable, should be the same as the English version of the approved labels. The details required are as follows:
 

所有中成药标签必须以英文书写。标签上也可刊印中文或其他语文但内容应和英文版本一致。标签的具体要求如下:

Inner label must state:

内标签必须注明:

  • Trade / brand name 药品商标
  • Product name 药品名称
  • Batch number 批号
  • Expiry date 有效期
  • Names and quantities of ingredients * 成份名称及份量* 

*  If inner label is too small, the information may be stated on the outer label.

* 如内标签的空间有限,这些资料必须注明于外标签。
 

Outer label must state:

外标签必须注明:

  • Trade / Brand name 药品商标
  • Product name 药品名称
  • Batch number 批号
  • Expiry date 有效期
  • Importer's or wholesaler's name and address **  进口商/批发商的公司名称及地址** 
  • Manufacturer's name and address ** 制造商的公司名称及地址**
  • Assembler's name and address (if any) ** 分装商的公司名称及地址(如有)**
  • "Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。"** (Please see below for more details) (请参阅下文了解更多详情)

** If there is no outer label, the information may be stated in the inner label.

** 若无外标签,这些资料必须注明于内标签。

Additional label  附加标签:

"Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority.  Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。" 

  • The words must be clearly legible and printed in an indelible manner. 文字必须清晰且不易擦除。
  • The English words should not be less than 1.5 mm in height and the Chinese characters not less than 2 mm in height. 其英文与中文字体的高度分别不得少于1.5毫米 及 2.0毫米 。
  • The words must be enclosed in a boxed area which is clearly visible. Nothing else should appear in the boxed area other than the words of the label.  文字必须以明显可见的框围住,框内只限附加标签的文字。
  • The label must appear conspicuously in a prominent position. 附加标签在产品包装上的位置必须显眼。

 

Package insert must state:

说明书必须注明:

  • Trade / Brand Name 药品商标
  • Product Name 药品名称
  • Manufacturer's name and address 制造商的公司名称及地址
  • Names & quantities of ingredients 成份名称及份量
  • Dosage ***  药品用量*** 
  • Indication *** 药品的适应症*** 
  • Contraindication ***  药品的禁忌症***
  • Side effects *** 药品的副作用***
  • The frequency and method of administration ***  药品服食法***

*** If there is no leaflet, the information may be stated on either the inner or outer label. 
*** 若无说明书,这些资料必须注明于内或外标签。

Prohibition of Stipulation of Certain Diseases / Conditions 禁止涉及某些疾病/症状

The labels, packaging and package inserts of CPM shall not make references to any of the 19 diseases/conditions specified in the First Schedule to the Medicines Act:

中成药的标签,包装及说明书都不能提到以下的19种疾病/症状:

1. Blindness  失明

11. Leprosy  麻风

2. Cancer  癌症

12. Menstrual disorders  有关月经(月事)疾病

3. Cataract  白内障 

13. Paralysis  瘫痪症

4. Drug addiction  毒瘾

14. Tuberculosis  结核病

5. Deafness  耳聋

15. Sexual function  性机能

6. Diabetes  糖尿病

16. Infertility  不育症

7. Epilepsy or fits  癫痫或抽搐

17. Impotency  阳萎

8. Hypertension  高血压

18. Frigidity  性冷感

9. Insanity  神经错乱

19. Conception and pregnancy  受孕或怀孕

10. Kidney diseases  肾病

 

Updated-Sep 17