新加坡注册中成药申请产品批准的呈交详情

更新时间:2023-07-30 08:03:12 阅读：评论：0

Submission of Application 申请产品批准的呈交详情

CPM importers, manufacturers and asmblers are also required to obtain product approvals for the CPM products dealt by them.

The following items must be submitted during applications for CPM product approvals:

所有中成药进口商、制造商和分装商都必须为他们经销的中成药取得产品批准。

申请中成药产品批准必须提供下表中要求的资料:

三及黄片

Item 要求的资料	For imported product 进口产品	For locally manufactured product 本地制造的产品
Sample and labels of product to be sold/supplied in Singapore which meet labelling requirements, including: 将在本地销售的药品样本及标签(需符合标签要求),包括: a) Inner label 内标签 b) Outer label / carton (if any) 外标签(若有) c) Package inrt (if any) 说明书(若有)
Sample and labels of product sold/supplied in country of manufacture, including: 在原产国销售的药品样本及标签,包括: a) Inner label 内标签 b) Outer label / carton 外标签(若有) c) Package inrt (if any) 说明书(若有)
Manufacturer's Licence or certificate 制造商执照或证书
Good Manufacturing Practice (GMP) certificate (if any) GMP证书(若有)
Free sale certificate or equivalent from country of manufacture 原产国所签发的自由销售证书或同等文件
Product registration certificate for products from China (if applicable) 药品的批准证书(限于中国生产的产品)
Test results of toxic heavy metals and microbial contamination 有毒重金属及卫生学检验报告
Endorment of product formula (including all active and inactive ingredients) by overas manufacturer and undertaking by overas manufacturer that product does not contain any Western drugs or active synthetic substances 外地制造商确认的药品成份表(包括活性和非活性成份),和药品不含任何西药或活性合成物质的书面声明
Information on legal classifications of product in countries of sales 药品在其它销售国家的分类

* Except products imported for local asmbly 进口后将在本地进行分装或包装的产品除外

In addition to the above items, dealers may be required to furnish any other information as requested by the Licensing Authority.

除了以上要求，执照签发当局也可能要求申请人提供其它的资料或文件。

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*
(except for cret & protected formula) (除非是秘方或保护方)

*骚宾 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**

∙Asmbler's name and address (if any) ** 分装商的公司名称及地址(如有)**

∙"Allowed for sale as a Chine Proprietary Medicine bad on information submitted to the Authority. Consumer discretion is advid. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。"** (Plea e 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 Chine Proprietary Medicine bad on information submitted to the Authority. Consumer discretion is advid. 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 Chine 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 enclod in a boxed area which is clearly visible. Nothing el 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 inrt must state:

说明书必须注明：

∙Trade / Brand Name 药品商标

∙Product Name 药品名称影响的英语

∙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
(except for cret & protected formula) (除非是秘方或保护方)

∙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 Dias / Conditions 禁止涉及某些疾病／症状

The labels, packaging and package inrts of CPM shall not make references to any of the 19 dias/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	胎教故事100个必读13. Paralysis 瘫痪症
4. Drug addiction 毒瘾工资税率>坐定	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
古代香艳小说 10. Kidney dias 肾病

Secret & Protected Formula 秘方及保护方

The name of ingredients and their strengths need not be stated in the label and package inrt if the formula of the CPM has been certified by the relevant health authority of the exporting country as "cret" or "protected".

如果该中成药被出口国卫生或管理当局证明为“秘方”或“保护方”,则不必在标签或说明书上透露药品的成分及份量。

Toxic Heavy Metals and Microbial Limits 有毒重金属与卫生学的限制

Toxic heavy metals limits for CPM products are as follows (有毒重金属的检验):

	Permissible limits 限制
Arnic 砷	5 ppm
Copper 铜	150 ppm
Lead 铅	20 ppm
Mercury 汞	0.5 ppm

Microbial limits for CPM products are as follows (卫生学检验):

For oral CPM 中成药(口服)	Microbial limits 限制
Total aerobic microbial count * 需氧微生物的总数*	Not more than 105 per g or ml 每一克或一毫升不超过105
Yeast and mould count * 酵母及霉菌*	Not more than 5 X 102 per g or ml 每一克或一毫升不超过5 X 102
Abnt in 1g or ml: 每一克或一毫升的药品不能有任何:	Escherichia coli 大肠埃希氏杆菌 Salmonellae 沙门氏菌族 Staphyloccocus aureus 金黄色葡萄球菌
For topical CPM 中成药(外用)	Microbial limits 限制
Total aerobic microbial count * 需氧微生物的总数*	Not more than 104 per g or ml 每一克或一毫升不超过104
Yeast and mould count * 酵母及霉菌*	Not more than 5 X 102 per g or ml 每一克或一毫升不超过5 X 102
Abnt in 1g or ml: 每一克或一毫升的药品不能有任何:	杂志制作Pudomonas aeruginosa 绿脓假单胞菌 Staphyloccocus aureus 金黄色葡萄球菌

* The limits do not apply to CPM derived from fermentation process

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新加坡注册中成药 申请产品批准的呈交详情

新加坡注册中成药申请产品批准的呈交详情