Regulatory Affairs



A Summary of Hong Kong Registration Requirements for Overseas Manufacturers / Suppliers.


   
  1. Letter from manufacturer authorizing distributor company to handle the product registration.

  2. Letter from manufacturer confirming that which manufacturer(s) is/are involved in the manufacturing and quality assurance process.

  3. GMP Certificate(s) with stating compliance to WHO standard of all manufacturer(s) involved in the manufacturing process : certified true copy.

  4. Manufacturer's license: certified true copy.

  5. Free sales certificate (FSC) or certificate of pharmaceutical product (CPP) of product : original or certified true copy.

  6. Prototype sales pack (e.g. ready for printing artworks of outer carton, container label, package insert, blister foil and other component(s) comprising the sales pack) for each pack size of the product, complied fully to the Hong Kong labelling requirements.

  7. Document(s) to support the proposed indication(s), dosage, route of administration and other contents of the package insert.

  8. Scanned image or photograph image of sale pack including the inner container/packaging and the unit dose form image of the product clearly showing the complete contents of the sales pack and its component(s).

  9. Detailed and complete qualitative and quantitative composition of the finished product, issued by the manufacturer. Batch formula is not accepted as alternative to the requirement. Non-proprietary names of ingredients, colour Index number or E-number for all colourants used (including capsule shells) should be provided.

  10. Specifications of the product issued by the manufacturer. Document(s) showing compliance with one or more of the following pharmacopoeias must be provided unless otherwise justified: Pharmacopoeia of the People's Republic of China, British Pharmacopoeia, European Pharmacopoeia, International Pharmacopoeia, Japanese Pharmacopoeia and/or United States Pharmacopoeia.

  11. Detailed method of analysis of the product for all tests stated in the finished product specifications.

  12. Certificate of analysis of a representative batch of the finished product, issued by the manufacturer or the company performing the analysis.

  13. Stability test data.

  14. If materials of animal origin (e.g. empty capsules) are used in the manufacturing of the product, you should also provide documentary evidence obtained from the manufacturer on the source of the animals, the nature of the animal tissues used in the manufacturing and the production processes, showing compliance with one or more of the safety measures taken to minimize the risk of communicable diseases that can be transmitted to human, including but not limited to Transmissible Spongiform Encephalopathy (TSE) transmission promulgated by the European Medicines Agency, USA or Australia.