HOW IT RUNS
From assessment to market
Prepare for a first consultation
- 01Product category and target market
- 02Existing registrations or certifications
- 03Label and package insert documents
- 04Preferred timeline
- 01Classification and pathway
Determine which regime applies and which route to take.
- 02Checklist and gap analysis
What is missing and what to prepare, listed once.
- 03Project coordination
Work with local entities, testing and filing parties.
- 04Connect the channels
Import, wholesale and online channels link up after registration.
FAQ
Frequently asked questions
- What does Hong Kong pharmaceutical registration require, and how long does it take?
- Typically quality, safety and efficacy data, proof of marketing authorisation in the country of origin and GMP evidence, assessed by the Pharmacy and Poisons Board of Hong Kong. Timelines depend on product category and completeness of the dossier; we do not commit to registration outcomes or timing.
- Who holds the registration?
- The applicant for a Hong Kong pharmaceutical product registration must be a company registered in Hong Kong. The brand's own Hong Kong entity can hold it, or we can act as applicant or holder by agreement, with rights and obligations set out in the cooperation contract.
- Who supplies the market after registration?
- We can supply under our wholesale licence, or another licensed wholesaler nominated by the brand can; registration and supply can be agreed separately.
- Which part of mainland market access do you handle?
- Mainland registration and import clearance are led by licensed mainland entities. We prepare Hong Kong-side materials, coordinate samples and documents, and provide information and introductions for the Hong Kong-Macao Medicine and Device Connect scheme and cross-border e-commerce routes.
- How are fees calculated?
- Quoted per project scope, itemised by dossier preparation, agent filing, sample and testing coordination, and started only after written confirmation.
READ BEFORE ENQUIRING
Conditions requiring case-by-case confirmation
- ✓Registration support is an assessment and coordination service; we do not promise approval outcomes or timelines
- ✓Applicant eligibility and legal responsibility are determined by applicable regulations
- ✓Specific requirements of each regime follow the regulator's current guidance
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