Unlock Faster Market Access for Your New Pharmaceutical Products in Hong Kong
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Perks of Streamlining
Your Licensing Process
with Premia TNC
Perks of Streamlining Your Licensing Process with Premia TNC
Faster Market Entry
Streamlining reduces delays, allowing pharmaceutical companies to introduce new products more quickly and seize market opportunities.
Cost Efficiency
A simplified process lowers administrative and operational costs, helping businesses allocate more resources toward innovation and R&D.
Improved Transparency and Compliance
A well-structured licensing pathway enhances communication with regulatory authorities and ensures adherence to evolving global standards.
Enhanced Stakeholder Confidence
Efficient registration processes foster trust among investors, partners, and consumers by demonstrating professionalism and regulatory diligence.
At Premia TNC, we support pharmaceutical companies by providing expert guidance throughout the licensing and registration process. Our team ensures compliance with local and international regulations, helping businesses achieve smooth market entry with minimal delays.
A Trustworthy firm, serving 6,000+ clients in corporate matters
Fast-track the Registration Process with
Three Simple Steps:
Step 1
Ensure all required documents are accurate and fully compliant with Hong Kong’s regulatory standards, including:
- Product formulation and ingredient list.
- Manufacturing processes and quality control measures.
- Clinical data (if applicable) to demonstrate safety and efficacy.
Step 2
Step 3
The regulatory authorities will evaluate your submission. Upon approval, you will receive official product registration, authorizing the sale and distribution of your pharmaceutical product in Hong Kong.
Ready to register your product?
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Primary Factors for Registration
for New Pharmaceutical Products
Requirements to Register
All pharmaceutical products must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold, distributed, or possessed for such purposes. Registration is contingent upon demonstrating the product’s safety, efficacy, and quality. Applications must be submitted via the PRS 2.0 system and include documents such as the manufacturer’s license, GMP certificate, Free Sale Certificate, product formula, stability data, specifications, clinical documentation, and bioequivalence data (if applicable). Fees apply upon submission and approval.
Qualifications and Credentials
Applicants must be either a licensed manufacturer or a licensed wholesale dealer in Hong Kong. If the product is imported, the applicant may also be a local branch, agent, or distributor of the overseas manufacturer. Essential documentation includes business registration certificates and authorization letters. Additionally, manufacturers must comply with international GMP standards (e.g., PIC/S) and provide detailed technical documentation to support product quality and regulatory compliance.
Why People Trust Us
We extend special thanks to our partners.
We have a long history of working with various sizes of corporation of renowned brands.
Our Clients Rely On Our Expertise
We have worked with 6,000+ clients and Partners 90% of our clients recommend us
Here’s what our clients have to say:
Frequently Asked Questions
1. What are the essential steps for registering a new pharmaceutical product?
2. How long does the registration process typically take?
3. What qualifications are required for individuals involved?
4. Is there a cost involved in the registration process?
Yes, regulatory agencies usually charge fees for the evaluation and review of pharmaceutical product applications. These fees differ by jurisdiction and are influenced by the type and category of the product being registered.
5. What are the next steps once the product receives approval?
Still carrying concerns?
Reach out today and speak with our expert consultants.
