Overview of Chinese Proprietary Medicines (CPM) Wholesaler's Licences
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CPM Wholesaler Licensing in Singapore
Overview of Chinese Proprietary Medicines (CPM) Wholesaler's Licences
Understand the licensing requirements before you wholesale Chinese Proprietary Medicines in Singapore
In Singapore, the wholesale of Chinese Proprietary Medicines (CPM) is strictly regulated by the Health Sciences Authority (HSA) to ensure the safety and quality of these products. Companies intending to wholesale CPM must obtain a Wholesaler's Licence for CPM from HSA.
Here's an overview of the key aspects:
1. What is a Chinese Proprietary Medicine (CPM)? A CPM is generally defined as a finished medicinal product (e.g., tablet, capsule, liquid) containing one or more active ingredients from plants, animals, or minerals, or a combination thereof, all of which are documented for use in traditional Chinese medicine. Products for injection, or those containing chemically-defined isolated constituents as active ingredients, are generally not considered CPM.
2. Licensing Requirements: To wholesale CPM in Singapore, your company generally needs to hold:
An Importer's Licence for CPM (if you are importing the CPM).
A Wholesaler's Licence for CPM.
Exceptions:
If you are importing CPM solely for export or re-export to another country, you typically do not need an import license for CPM, but you will need an import for re-export permit.
If you hold a valid Manufacturer's Licence for CPM, you do not need a separate Wholesaler's Licence to wholesale the CPM you have manufactured.
Wholesale of unlisted CPM for use as clinical research materials in clinical trials generally does not require an import or wholesale license, but a Clinical Research Material (CRM) Notification to HSA is required.
3. Key Requirements for Obtaining a Wholesaler's Licence:
Locally Registered Entity: The applicant must be a locally registered entity in Singapore (e.g., with ACRA).
Good Distribution Practice (GDP) Compliance: This is a mandatory requirement. Your company's premises and quality management system must comply with GDP standards. HSA will conduct an audit of your premises to assess compliance before granting the license. This involves demonstrating:
Proper storage areas (receiving, quarantined, released, rejected, returned, recalled, outgoing staging).
A robust Good Distribution Practice Standard Operating Procedure (SOP).
Good Distribution Practice records or recording templates.
Clear contracts for outsourced activities (if any).
Responsible Person (RP): A qualified Responsible Person (RP) must be named in the license. This person is employed by the licensee to implement and maintain an effective quality management system that meets GDP standards. For CPM, the specific qualifications for the RP are not explicitly stated as requiring a registered pharmacist, unlike for active ingredients for therapeutic products, but relevant qualifications and experience are expected.
Product Listing Approval: For CPM imported for local use, you are required to obtain at least an "in-principle approval" for the CPM product listing application before applying for the import license for CPM. The issuance of the import license is subject to this product listing approval and the satisfactory close-out of the GDP audit.
Labeling and Packaging Compliance: CPM products must comply with strict labeling regulations, including:
Bilingual advisory note to consumers (English and Chinese).
Trade/brand name, product name, batch number, expiry date.
Names and quantities of ingredients.
Manufacturer's name and address.
Dosage, indication, contraindication, and side effects.
Frequency and method of administration.
Prohibition of claims related to certain diseases or conditions.
No restricted ingredients (e.g., synthetic drugs, heavy metals, or Western drugs beyond permissible limits).
Safety and Quality Criteria: CPM must meet safety and quality criteria, including permissible limits for toxic heavy metals and microbial contamination. Importers need to submit documents demonstrating the absence of Western drugs and test results for heavy metals and microbial content.
4. Application Process:
Applications are typically submitted via the PRISM (Pharmaceutical Regulatory Information System) system.
Required documents often include:
Company registration details (ACRA).
Current layout plan of the premises, specifying storage areas.
Good Distribution Practice SOPs and records.
Product details and supporting documents (labeling, composition, QA systems).
Declaration of compliance with regulations.
HSA will conduct a GDP audit of your premises. The license will only be approved after successful compliance with GDP standards.
5. Validity and Renewal:
A wholesaler's license is typically valid for 12 months from the date of approval.
Renewal is essential for uninterrupted business operations. HSA sends renewal reminders.
Companies can often opt for an auto-renewal scheme via GIRO. Otherwise, manual renewal is required.
A lapsed license cannot be renewed, and a new application must be submitted.
6. Regulatory Framework: The regulation of CPM in Singapore falls under the purview of the Health Sciences Authority (HSA), guided by legislation such as the Medicines Act and its subsidiary regulations, including the Medicines (Labelling of Chinese Proprietary Medicines) Regulations.
Turnaround time (TAT)
The turnaround time (TAT) for obtaining a Chinese Proprietary Medicine (CPM) Wholesaler's Licence in Singapore involves several stages, and it's crucial to understand that the "stop-clock" mechanism is in play. This means that any time taken for the applicant to respond to HSA's requests for clarification or additional information is excluded from the official TAT.
Here's a breakdown of the typical processing times:
1. CPM Product Listing Application (Prerequisite for Local Use):
New Product Listing: 60 working days (excluding applicant's stop-clock).
This is a critical step if you intend to import CPM for local use, as you generally need at least "in-principle approval" for product listing before applying for the import license.
2. Good Distribution Practice (GDP) Audit and Certification:
GDP Certificate Application/Audit: 10 working days from the date of audit close out.
Compliance with GDP standards is mandatory. HSA will conduct an audit of your premises. The licence will only be approved after your company is found to have complied with the required GDP standard and the audit findings are closed out.
3. Wholesale Dealer's Licence (for CPM):
New Application or Annual Renewal: 10 working days from the date of audit close out (for new applications) or from the date of technical assessment completion / audit close out.
Amendment Application: 10 working days from the date of audit close out (if an inspection is required).
Key Takeaways on Turnaround Time:
Audit-Dependent: The actual issuance of the wholesale license is heavily dependent on the successful completion and close-out of the GDP audit. This is often the longest variable in the entire process.
Applicant's Responsiveness is Key: As mentioned, the "stop-clock" mechanism means delays in responding to HSA's queries or requests for information will extend the overall process significantly. Providing complete and accurate documentation upfront can help expedite the process.
Multiple Stages: Remember that obtaining the CPM Wholesaler's Licence isn't a single application. It often involves:
CPM Product Listing (if for local sale).
GDP Audit and Certification.
Application for the Wholesaler's Licence (and potentially an Importer's Licence).
While HSA strives to meet these turnaround times, it's always advisable to plan for potential delays and initiate the application process well in advance of when you intend to begin wholesaling activities. You can find the most accurate and up-to-date information on the HSA website.
Fees
When applying for Chinese Proprietary Medicines (CPM) wholesaler's licences in Singapore, it's important to be aware of the associated fees.
Here's a breakdown of typical fees:
Application Fee for a New Wholesale Dealer's Licence (including for CPM): S$560
Licence Fee for Each Subsequent Year: S$560
Important Considerations:
Import Licence (if applicable): If you are importing CPM for wholesale, you will also need an Import Licence for CPM. The fees for this are generally the same as the Wholesale Dealer's Licence:
Application Fee for a New Import Licence: S$560
Licence Fee for Each Subsequent Year: S$560
There's also a bundled fee for an Importer's Licence (full scope) and Wholesaler's Licence, which can be around S$1,000.
Good Distribution Practice (GDP) Certificate: While not a direct license fee, obtaining a GDP certificate is a mandatory requirement for the wholesale license. There is a fee associated with the application for a GDP certificate, which can be around S$3,900. This covers the assessment and audit by HSA to ensure your premises and quality management system comply with GDP standards.
Amendment Fees: If you need to amend your licence (e.g., change of address, responsible person), there are typically fees involved:
Amendment without site inspection (administrative): S$57
Amendment with site inspection: S$330
Product Listing Fees: There are generally no fees for the application of a new CPM product listing or for amending or transferring a product listing. This is a separate process from the dealer's license but is a prerequisite for importing CPM for local sale.
Payment: Fees are typically paid through the PRISM (Pharmaceutical Regulatory Information System) during the application process.
It is highly recommended to refer to the official HSA website for the most up-to-date and detailed information on CPM wholesaler licensing requirements in Singapore, as regulations can change.
How Bestar can Help
Overview of Chinese Proprietary Medicines (CPM) Wholesaler's Licences
Navigating the regulatory landscape for Chinese Proprietary Medicines (CPM) in Singapore can be complex, especially with stringent requirements like Good Distribution Practice (GDP) compliance and product listing. This is where Bestar can be invaluable.
Here's how Bestar can help companies applying for a CPM Wholesaler's Licence in Singapore:
1. Expert Guidance and Regulatory Strategy:
Understanding Requirements: Bestar possesses in-depth knowledge of HSA regulations, guidelines, and the nuances specific to CPM. We can accurately interpret the requirements for product listing, import, and wholesale licenses, ensuring no critical detail is overlooked.
Gap Analysis: We can conduct a thorough assessment of your current operations, facilities, and documentation to identify any gaps in compliance with HSA's GDP standards.
Tailored Strategy: Based on your company's specific needs and products, we can develop a clear, step-by-step regulatory strategy to achieve the necessary licenses efficiently.
2. Good Distribution Practice (GDP) Implementation and Compliance:
SOP Development: GDP compliance is a major hurdle. Bestar can help draft, review, and refine your company's Standard Operating Procedures (SOPs) to ensure they meet HSA's GDP guidelines. This includes procedures for receiving, storage, quality control, returns, recalls, and distribution.
Facility Layout and Management: We can advise on optimizing your warehouse layout to comply with GDP requirements, including proper segregation of products (quarantined, released, rejected), temperature control, and security measures.
Quality Management System (QMS): Bestar assists in establishing and implementing a robust QMS that is compliant with GDP, covering aspects like documentation control, personnel training, self-inspections, and deviation management.
Pre-Audit Preparation: We can conduct mock GDP audits to prepare your team and premises for the actual HSA inspection, identifying and rectifying potential issues before the official audit, significantly increasing the chances of a successful audit outcome.
3. Application Preparation and Submission:
Documentation Management: The application process involves extensive documentation for both product listing and dealer's licenses. Bestar can help compile, organize, and review all required documents, ensuring completeness and accuracy (e.g., product formulation, test reports, labeling, quality certificates).
PRISM Submission: We are familiar with the PRISM e-service system and can assist in the efficient and accurate submission of your applications, minimizing errors that could lead to delays.
Responding to Queries: If HSA raises queries or requests additional information (the "stop-clock" mechanism), Bestar can help formulate prompt and comprehensive responses, preventing unnecessary delays in the application process.
4. Responsible Person (RP) Training and Support:
While the specific qualifications for a CPM RP might not be as stringent as for Western medicines, Bestar can provide training and guidance to your designated Responsible Person to ensure they fully understand their roles and responsibilities in maintaining GDP compliance.
5. Post-Licensing Compliance and Maintenance:
Ongoing Compliance: Regulations can evolve. Bestar can provide updates on regulatory changes and help you maintain ongoing compliance through regular reviews of your QMS and SOPs.
Renewal Support: We can assist with the annual renewal of your licenses, ensuring all requirements are met on time.
Benefits of Engaging Bestar:
Increased Success Rate: Expertise significantly boosts the likelihood of successful application and audit outcomes.
Time and Cost Savings: By streamlining the process and avoiding common pitfalls, Bestar can save your company significant time and resources in the long run.
Risk Mitigation: We help minimize the risk of non-compliance, which can lead to penalties, product recalls, or license revocation.
Focus on Core Business: Outsourcing the regulatory complexities allows your team to focus on their core business activities.
When choosing a consultant, look for Bestar. We have a proven track record in HSA regulations, specifically with experience in CPM, and strong knowledge of GDP standards.
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