How to Apply for Import and Export Licences for Pharmaceutical Products and Medicines
Pharmaceutical Products and Medicines
In Hong Kong, "Pharmaceutical Products and Medicines" refer to substances used to diagnose, treat, cure, or prevent diseases and medical conditions. They encompass a wide range of products, from simple pain relievers to complex biologics and vaccines.
Key points to remember:
Registration Requirement:
Most pharmaceutical products must be registered with the Pharmacy and Poisons Board before being sold in Hong Kong.
Hong Kong Med Import/Export License
Here's a comprehensive guide on how to apply for import and export licenses for pharmaceutical products and medicines in Hong Kong:
1. Understand the Regulatory Framework:
Import and Export Ordinance (I & E Ordinance): This ordinance mandates that all imports and exports of pharmaceutical products and medicines in Hong Kong require a license from the Trade and Industry Department (TID).
Pharmaceutical and Therapeutic Products Ordinance (PTPO): This ordinance regulates the safety, quality, and efficacy of pharmaceutical products and medicines in Hong Kong.
2. Determine the Type of License Required:
The type of license you need will depend on the specific pharmaceutical products or medicines you are importing or exporting. Common types of licenses include:
Import License (Form 3): Required for importing pharmaceutical products and medicines into Hong Kong.
Export License (Form 6): Required for exporting pharmaceutical products and medicines from Hong Kong.
3. Prepare Required Documents:
The specific documents required may vary depending on the type of license and the nature of the pharmaceutical products or medicines involved. However, some common documents include:
Company registration certificate
Business license
Product registration certificate
Certificate of Analysis
Manufacturing license
GMP certificate
Product label
Product packaging
Bill of lading
Commercial invoice
Packing list
4. Submit the Application:
Application Procedures
Prior to submitting a license application to the Trade and Industry Department for the import or export of pharmaceutical products and medicines, applicants must secure the endorsement of the Pharmacy and Poisons Board. Submit the completed import or export license application, in quadruplicate or triplicate respectively, to the following address:
Pharmaceuticals Registration and Import/Export Control Section
Department of Health
3/F, Public Health Laboratory Centre
382 Nam Cheong Street
Kowloon
Tel No. : 2319 8460
A numbered receipt will be issued upon submission of the application. Approved applications will be endorsed and forwarded to the Trade and Industry Department for further processing. Applicants may collect the processed applications from the Pharmaceuticals Registration and Import/Export Control Section upon presentation of the receipt.
Upon approval of an import license application, the applicant will be issued with an original and a duplicate license. The original license must be presented to the carrier within 7 days of importation, as stipulated in Section 8 of the I&E Ordinance, regardless of whether goods have been claimed. The duplicate license should be retained by the licensee.
Upon approval of an export license application, the licensee will be issued with an original license. This original license must be surrendered to the carrier before the goods can be accepted for export, as stipulated in Section 10 of the I&E Ordinance.
5. Wait for Approval:
The processing time for import and export license applications can vary depending on the complexity of the application and the availability of required documentation. Once the application is approved, the TID will issue the license.
Fees
The licence application forms are available for sale:
Form 3
$26 per pad of 20 sets
$3 per set
Form 6
$16 per pad of 20 sets
$3 per set
Applications for import license Form 3 and export license Form 6 covering pharmaceutical products and medicines, as well as applications for import and export authorizations covering controlled chemicals, are not subject to any fees.
Additional Tips:
Engage a Licensed Customs Broker: A licensed customs broker can help you navigate the complex import and export procedures and ensure compliance with all regulations.
Important Resources:
Trade and Industry Department (TID): https://www.tid.gov.hk/english/aboutus/publications/nontextiles/files/medicines.pdf
Drug Office: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html
Pharmaceuticals Licence Application and Movement Monitoring System (PLAMMS): https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html
Drug Office: https://www.drugoffice.gov.hk/eps/do/en/consumer/reg_pharm_products/index.html 1
By following these steps and seeking professional advice, you can successfully apply for import and export licenses for pharmaceutical products and medicines in Hong Kong.
How Bestar Can Help
How to Apply for Import and Export Licences for Pharmaceutical Products and Medicines
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