|
2010进口保健食品注册手续简章
北京天健华成国际投资顾问有限公司 保健食品部
【相关文章：1.保健食品注册全攻略2.进口保健食品申报攻略3.2009全新保健食品申报注册功略4.新旧《保健食品注册管理办法》对比看5.中国保健食品批件注册手续完全指导手册6.国产保健食品批件注册手续完全指导手册7.进口保健食品注册手续简章8.国产保健食品注册手续简章9.保健食品注册问答】
本文为有志于进行保健食品生产、销售、进口的国内外企业提供政策及程序上的友情指导。
1、外国保健食品进口到中国要办理什么手续？
天健华成：国外进口保健食品在进入中国大陆市场之前都必须接受国家食品药品监督管理局（SFDA）的审批。中国对进口保健食品实行注册审核制度：进口保健食品须领取《进口保健食品批件》，未领取该《批件》的进口保健食品不得在中国大陆市场上销售。只有获取了中国SFDA颁发的《批件》，才算拿到了进入中国大陆保健品市场的入关证，才能够进行销售。也只有获取了《批件》，才能使报关这一步骤得以顺利进行。报关时，海关部门要求您提供《批件》并进行核实，否则产品只能被扣留或退回。
2、什么样的产品需要注册保健食品？
天健华成：如果您的产品需要宣称具有某种保健功能，或者所采用的原料、剂型不属于普通食品的，就必须进行保健食品注册。保健食品不可以声称有治疗作用。
3、保健食品可以注册哪些功能？
天健华成：一共有28种功能可以申报：1.增强免疫力 2.抗氧化 3.辅助改善记忆 4.缓解体力疲劳 5.减肥 6.改善生长发育 7.提高缺氧耐受力 8.对辐射危害有辅助保护功能 9.辅助降血脂 10.辅助降血糖 11.改善睡眠 12.改善营养性贫血 13.对化学性肝损伤有辅助保护功能 14.促进泌乳 15.缓解视疲劳 16.促进排铅 17.清咽 18.辅助降血压 19.增加骨密度 20.调节肠道菌群 21.促进消化 22.通便 23.对胃粘膜有辅助保护功能 24.祛痤疮 25.祛黄褐斑 26.改善皮肤水份 27.改善皮肤油份 28.营养素补充剂
4、进口保健食品注册要多少费用，周期多久？
天健华成：根据注册保健功能的不同会有不同的费用，无法一概而论。一般来说，进口保健食品注册单独的保健功能，官方费用（目前主要是检验费）大约在15~33万（营养素补充剂可能会在3~5万），注册周期大约在一年~两年半。
5、进口保健食品注册的申请程序
天健华成：首先提供样品进行检验，检验完成后再进行注册申请。申请的部门为国家食品药品监督管理局（SFDA）。全部注册资料先要交给SFDA进行初审，如果没有问题就正式受理了，SFDA会在80个工作日内组织专家会议进行审评，提出补充意见，经过补充修订以后，对于合格的产品予以批准，颁发进口保健食品批准证书。
6、进口保健食品注册需要检验什么？
天健华成：进口保健食品注册必须在中国检验机构进行样品检验。检验项目包括：卫生学、稳定性、功效成分检验、功能试验、安全性试验。有的产品还需要进行兴奋剂检验。
7、进口保健食品注册需要提供哪些资料？
天健华成：首先，境外申请人应当是境外合法的保健食品生产厂商。境外申请人办理进口保健食品注册，应当由其驻中国境内的办事机构或者由其委托的中国境内的代理机构办理。注册申请时需要向国家提供样品、产品研发报告、配方依据、检验报告、质量标准、生产工艺、标签说明书样稿及实样、证明性文件等21项资料。证明性文件包括：1.生产国（地区）有关机构出具的该产品生产企业符合当地相应生产质量管理规范的证明文件；2.《外国企业常驻中国代表机构登记证》复印件或委托书及受委托机构的营业执照复印件；3.产品在生产国（地区）生产销售一年以上的证明文件；4.生产国（地区）或国际组织的与产品相关的有关标准。有关文件须要进行国内外的公证及使馆确认。
如果委托国内的专业代理注册公司进行注册申请，只需要提供样品、配方、生产工艺、产品说明书及标签实样、证明性文件等几项资料就可以了，其他的项目他们会帮助您准备好。
以上内容欢迎与本文作者交流Email：guoxx100@126.com，qq：915369983，微信1801335159或登录中国注册申报网http://www.zhuceabc.cn，咨询热线:86-010-84828041/42。
Imported health food registration procedures outlined
1, the foreign health food imported to China must go through the procedure?
Imported health food market in mainland China must be accepted before the State Food and Drug Administration (SFDA) approval. Introduced on imported health food registration verification system: imported health food products are required to apply “imported health food approval document” does not receive the “approval document” shall not be imported health food products on the market in mainland China. China SFDA issued only for the “approval document”, be considered to get the health care products into the Chinese mainland market of entry permits can be sold. Only get the “approval document” in order to make the declaration that the procedures will be carried out smoothly. Declaration, the customs authorities require you to provide “approval document” and verified, or products can only be detained or returned.
2, what kind of health food products need to register?
If your product needs with a health function claims, or the use of raw materials, dosage forms are not ordinary food, health food products must be registered. Health food can not claim to have therapeutic effects.
3, which features health food can be registered?
A total of 28 functions can be declared: 1. Strengthening the immune system 2. Antioxidant 3. Assisted to improve memory 4. Relieve physical fatigue 5. Slimming 6. To improve the growth and development 7. Improve the anoxia tolerance 8. On radiation hazards have assisted protection 9. antihyperlipidemic 10. auxiliary hypoglycemic 11. to improve the sleep of 12. to improve the nutritional anemia 13. on chemical liver injury secondary protection 14. promote lactation 15. easing eye fatigue 16. promote the excretion of 17. Qing pharynx 18. auxiliary blood pressure 19. to increase bone density 20. Regulation of intestinal flora 21. promote digestion 22. defecation 23. on the gastric mucosal protection with auxiliary 24. remove acne 25. Removing chloasma 26. to improve the skin water were 27. to improve the skin oils 28. nutrient supplements
4, how many imported health food registration fees, cycle time?
According to the registered features of different health-care costs will be different and can not be generalized. In general, imports registered a separate health food health functions, the official fee (currently primarily inspection fees) about RMB 15 to 30 ten thousand(Nutrient supplements may be RMB 3 to 5 ten thousand), registered a period of about two and a half in a year ~.
5, the import health food registration required test what?
Registration must be imported health food inspection institutions in China, the sample test. Inspection items include: hygiene, stability, efficacy component testing, functional testing, security testing. Some products also require doping test.
6, imported health food registration application procedures
First, sampling inspection, testing conducted after completion of registration. Application of the department for the state Food and Drug Administration (SFDA). All registration information to the SFDA first preliminary examination, if it is to formally accept the, SFDA will organize 80 working days of expert meetings to review, make additional comments, after a supplementary amendment after approval for qualified products, issuing import health food approval certificate.
7, the need for imported health food registration What information?
First, the foreign applicant shall be lawful outside the health food manufacturer. Overseas applicants for import health food registration, should its offices in the territory of China or its authorized agents for processing in China. Registration is required to provide samples to the State, R & D reports, formula based, inspection reports, quality standard, production process, label instructions comp and the real kind, that documents and other information 21. Documents that include: 1. Producing country (region) issued by the relevant institutions to local production companies manufacturing practices relevant supporting documents; 2. “Permanent representative offices of foreign enterprises registration certificate” or power of attorney and copy of by the commission’s business license; 3. products in the producing country (region) production and sales of more than one year certificate; 4. producing country (region) or international organization concerned with product-related standards. Relevant documents have to be notarized and the embassy confirmed that domestic and foreign.
If the commission agent registered domestic professional registration companies only need to provide samples, formula, production technology, product instructions and labels really like to prove a number of documents and other information is available, other projects they will help you prepare.
In case of doubt the above, please share this article on Email: guoxx100@126.com, qq: 915369983, Wechat：1801335159；or login network registration application in China (www.zhuceabc.com) registration of common sense and more dynamic. counseling hotline: 86-010-84828041 |
