「國珍牌松花粉」面向香港、美國、新加坡及東南亞客戶銷售。本頁匯總各地監管定位與合規要點,供消費者參考。以下為資訊性說明,不構成法律意見。
1. 香港(發貨地與註冊地)
本產品為香港衞生署註冊中成藥,註冊編號 HKC-16332,持牌人:中健國際香港國珍(ZHONGJIAN INTERNATIONAL H.K. GUOZHEN)。生產商:中國煙台新時代健康產業有限公司。產品標籤、廣告與銷售均按香港《中醫藥條例》及相關規管執行。
2. 美國
- 如以膳食補充劑形式銷售,須符合美國《聯邦食品、藥品和化妝品法》(FD&C Act)及膳食補充劑標籤規定(21 CFR 101.36);
- 產品聲明不得未經 FDA 評估即宣稱診斷、治療、治癒或預防疾病(參見免責聲明頁);
- 進口商/賣家須確保產品標籤、成分表、GMP 與入境申報合規;
- 各州對膳食補充劑另有登記與銷售要求,如加州 Proposition 65 等。
3. 新加坡
- 新加坡健康科學局(HSA)對健康補充品實行上市通報(notification),中成藥類產品須按《保健產品法》管理;
- 產品廣告須符合《保健產品(廣告)條例》,不得誇大療效;
- 進口須由持牌進口商申報,消費者個人進口受限額與條件約束。
4. 東南亞其他地區
馬來西亞(NPRA 產品註冊)、印尼(BPOM 註冊)、泰國(Thai FDA)、越南(DAV)、菲律賓(FDA Philippines)等地對保健品/中成藥均有不同的註冊、標籤與進口要求。部分成分(如特定花粉製品)在各國監管地位不同,請在當地購買或進口前確認合規要求。
5. 進口與稅務責任
國際訂單的進口合規、關稅、增值稅與清關責任由收件人/進口方承擔。如目的地監管機構要求產品註冊或標籤修改,相關責任由進口方負責。我們建議大宗或商業進口前諮詢當地專業顧問。
6. 一般說明
各國法規可能隨時變更,本頁內容僅反映當前了解的情況。如有疑問,歡迎聯絡我們:📞 852-24933102 / 852-35425518 | ✉️ hongkongtungkai@yahoo.com.hk
Guozhen Pine Pollen is sold to customers in Hong Kong, the United States, Singapore and Southeast Asia. This page summarises the regulatory positioning and key compliance points by market for consumer reference. The content is informational and does not constitute legal advice.
1. Hong Kong (Dispatch and Registration Base)
The product is a Chinese patent medicine registered with the Hong Kong Department of Health under Reg. No. HKC-16332, certificate holder: ZHONGJIAN INTERNATIONAL H.K. GUOZHEN. Manufacturer: Yantai New Era Health Industry Co., Ltd., China. Product labeling, advertising and sale are subject to the Chinese Medicine Ordinance and related requirements of Hong Kong.
2. United States
- If sold as a dietary supplement, the product must comply with the Federal Food, Drug, and Cosmetic Act and dietary supplement labeling rules (21 CFR 101.36);
- Product claims must not imply diagnosis, treatment, cure or prevention of disease without FDA evaluation (see the Disclaimer page);
- Importers/sellers must ensure compliance of labeling, ingredient lists, GMP and import declarations;
- States may impose additional requirements, such as California Proposition 65.
3. Singapore
- The Health Sciences Authority (HSA) administers health supplement notification; Chinese proprietary medicines are managed under the Health Products Act;
- Advertising must comply with the Health Products (Advertisement) Regulations and must not exaggerate efficacy;
- Imports must be declared by licensed importers; personal imports are subject to limits and conditions.
4. Other Southeast Asia
Malaysia (NPRA product registration), Indonesia (BPOM registration), Thailand (Thai FDA), Vietnam (DAV), and the Philippines (FDA Philippines) each impose different registration, labeling and import requirements for health products and Chinese medicines. Certain ingredients (e.g. specific pollen preparations) have different regulatory status in each country; please verify compliance before purchasing or importing locally.
5. Import and Tax Responsibility
Import compliance, duties, VAT and clearance responsibilities for international orders rest with the recipient/importer. If a destination regulator requires product registration or label changes, the importer is responsible. We recommend consulting local advisors before bulk or commercial import.
6. General Note
Regulations may change at any time; this page reflects our current understanding. For questions, contact us: 📞 852-24933102 / 852-35425518 | ✉️ hongkongtungkai@yahoo.com.hk