Comprehensive Guide: MAH Hong Kong

Introduction 

In Hong Kong’s highly regulated pharmaceutical market, the Marketing Authorization Holder (MAH Hong Kong) plays a pivotal role in ensuring that only safe, effective, and high-quality medicines reach patients.

This guide provides a detailed overview of the scope, responsibilities, processes, and documentation involved in MAH services in Hong Kong, along with a real-world case study at the end highlighting how Freyr successfully supported a Canadian pharmaceutical company with MAH transfer in the region.

Scope & Responsibilities of MAH in Hong Kong 

•  Accountability: The MAH is legally responsible for product safety, quality, and efficacy.
• Compliance Assurance: Must adhere to Hong Kong pharmaceutical regulations, Adverse Drug Reaction (ADR) reporting, and maintain active communication with the Drug Office.
• Outsourcing Oversight: If services like manufacturing or quality control are outsourced, the MAH must establish written contracts defining responsibilities, quality expectations, and record-keeping obligations.

Core Duties of the MAH 

• Pharmacovigilance: It is required to report all serious adverse drug reactions of registered drug occurring in Hong Kong as well as any actions taken by overseas drug health authorities on the same product to Drug Office.
• Change Management: Any change in manufacturing, packaging, or key personnel must be documented, justified, and reported to the Drug Office.
• Sample Storage: Reference and retention samples must be properly stored and transferred, especially during MAH changes or product withdrawal.
• Interaction: The MAH responds to authority queries, manages recalls, reports product defects, and ensures smooth communication with regulators.

Process Duration for MAH Transfer 

• The transfer of drug registration Hong Kong (change of registration particulars) typically takes up to 9 months.
• The timeline depends on documentation completeness, complexity of the change, and the Drug Office’s workload.
• Missing or incorrect documents can cause significant delays.

Essential Documentation 

• Letters of consent from old and new MAH
• Manufacturer or overseas MAH confirmation
• Business registration certificates
• Original product registration certificates
• Supporting documents in precise and searchable PDF formats submitted via PRS 2.0 (and certified copies where required)

Summary Table

Freyr Case Study: Supporting a Canadian Company with MAH Services in Hong Kong 

Client Overview:

A leading Canadian dermatology company sought Freyr’s support to manage their MAH transition and obligations in Hong Kong.

Project Details:

• Conducted a detailed gap analysis to align the client’s documentation with Hong Kong pharmaceutical regulations.
• Coordinated the transfer of MAH by compiling all necessary documentation, including letters of consent, business registration, and original product certificates.
• Oversaw interactions with the Drug Office to address queries and ensure timely progress.
• Assisted in appointing an Authorized Person in Hong Kong to oversee compliance, batch release, and interactions.

Outcome:

With Freyr’s end-to-end support, the client successfully completed the MAH transfer within the required timeline. This seamless transition allowed the company to maintain compliance, ensure product continuity in the Hong Kong market, and focus on core business operations while Freyr handled complexities.

Conclusion 

The MAH Hong Kong function is crucial for compliance and patient safety.

For pharmaceutical companies entering or operating in Hong Kong, having the right MAH partner is essential to reduce risks, accelerate approvals, and maintain long-term compliance. Contact Freyr today.