Bridging Pharmacy and Technology

First, It depends on the ingredients. If the product contains any active pharmaceutical ingredient, which needs professional judgement, it will likely be regarded as a pharmaceutical product. Second, if the product labels involves any health claim, it will still likely be regarded as a pharmaceutical product even it does not contain any active pharmaceutical ingredient. For more details about the Pharmacy and Poisons Ordinance, please refer to the websites: https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en, https://www.gld.gov.hk/egazette/pdf/20202430/es12020243019.pdf. For further details, we'd be more than happy to answer every question you have in mind.

To apply for the initial registration of a pharmaceutical product or substance, you must know if the product is manufactured in Hong Kong. If the product is manufactured in Hong Kong, the responsibility for registration lies with the licensed manufacturer or the licensed wholesale dealer working with the manufacturer. If the product is made outside Hong Kong, the responsibility falls to the licensed wholesale dealer who imports the product, or the Hong Kong branch, subsidiary, agent, or distributor of the overseas manufacturer. Once the application is approved, the applicant will receive the Certificate of Drug/Product Registration after paying the necessary fee. A pharmaceutical product will only be registered if it meets safety, efficacy, and quality standards. For more details on the required documents, please refer to the 'Guidance Notes on Registration of Pharmaceutical Products/Substances' available on the website: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf New applications for registration should be submitted via PRS 2.0 at the following website: https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp. For further guidelines, you can visit the Drug Evaluation and Import/Export Control Division at Suite 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon, or refer to the webpage here: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/pr_guide_main.html

Local serious adverse events should be reported within 15 calendar days. For details, please refer to the the webpage here: For details, please refer to the webpage here: https://www.drugoffice.gov.hk/eps/do/en/doc/Guidance_for_Pharmaceutical_Industry_en.pdf

To handle various classes of drugs, you must first obtain the appropriate trader license. (For more information, please refer to the FAQ on Licensing.) For each import or export transaction, you must apply for an Import License (Form 3) or Export License (Form 6) through the Drug Evaluation and Import/Export Control Division of the Department of Health. For further details, please see the guidelines and forms on "Import and Export," available on the office's webpage: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html

Wholesale and/or import/export of poisons and/or pharmaceutical products → Wholesale Dealer Licence(WDL) Manufacture of pharmaceutical products →Licence for Manufacturer Premises of an authorized seller of poisons(Part 1 or above) where poisons are kept for retail purposes→ Certificate for Registration of Premises of an Authorized Seller of Poisons(ASP) Retail sale of Part 2 poisons→Licence for Listed Sellers of Poisons(LSP) Wholesale and/or import/export of poisons and/or of antibiotics→Antibiotics Permit Manufacture of dangerous drugs(DD)→Licence to Manufacture Dangerous Drug Wholesale of dangerous drugs(DD)→Wholesale Dealer's Licence to Supply Dangerous Drug

First, you have to register with Environmental Protection Department as a Chemical Waste Producer. Second, you should contact the authorized chemical waste collectors to arrange for the disposal of the expired medicines. For details, please refer to the "Guidance on Disposal of Unserviceable/Expired Medicines for Licensed Pharmaceutical Traders" which is available at the webpage of the office: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/drugdisposalguidance_eng.pdf. For further details, we'd be more than happy to answer [every question](https://www.notion.so/FAQs-16b41946dafc804d9815f23b152d1ed2?pvs=21) you have in mind.