Hong Kong Certificate of Pharmaceutical Product (CPP) and Free Sale Certificate (FSC): Application Guide

Quick answer

What is a Certificate of Pharmaceutical Product in Hong Kong?

A Certificate of Pharmaceutical Product (CPP) in Hong Kong is an export certificate issued by the Department of Health (DH) Drug Office under Regulation 29 of the Pharmacy and Poisons Regulations (Cap. 138A). It confirms that a registered pharmaceutical product is manufactured by a licensed manufacturer in Hong Kong and is issued in the WHO certificate format for use by importing countries. A related document, the Free Sale Certificate of Pharmaceutical Product (FSC), confirms the product may be sold freely in Hong Kong — typically requested by overseas regulators as proof of local marketing status. Both certificates are export/certification documents, not product registrations. Registration in Hong Kong uses an HK-XXXXX number under the Pharmacy and Poisons Ordinance (Cap. 138); CPP and FSC are applied for separately once a product is registered and manufactured under a valid manufacturer licence. The manufacturer must submit the application to the Manufacturers Regulatory Unit (MRU). Fees are HK$140 (CPP) and HK$180 (FSC); DH performance pledges are 12 and 7 working days respectively upon receipt of complete documents. Applications may be filed by post, fax, email, in person, or via the Drug Office e-cert e-Form portal.

Who this applies to

This guide applies to:

• Licensed pharmaceutical manufacturers in Hong Kong seeking export certificates for products they manufacture
• Regulatory affairs and quality teams supporting export dossiers to ASEAN, Middle East, Latin America, and other markets that request WHO-format CPPs or free-sale evidence
• Registration certificate holders who are not the manufacturer — they may participate only with an authorization letter from the certificate holder, but the manufacturer must submit the application
• Export and trade compliance staff distinguishing CPP/FSC from product registration (HK-XXXXX), manufacturer licensing, and import/export licences

CPP and FSC do not replace Hong Kong medicine registration, GMP compliance, or import permits in destination countries. They are supplementary certificates for products already registered and manufactured under Hong Kong law.

Legal basis: Regulation 29, Cap. 138A

Regulation 29 of the Pharmacy and Poisons Regulations (Cap. 138A) authorises the Pharmacy and Poisons (Manufacturers Licensing) Committee to issue, for the purpose of exporting pharmaceutical products manufactured by a licensed manufacturer:

1. A free sale certificate of pharmaceutical product (FSC), or
2. A certificate of pharmaceutical product (CPP),

in the specified forms, subject to any conditions the Committee may impose.

The Drug Office of the Department of Health acts as the executive arm of the Committee. Applications are processed by the Manufacturers Regulatory Unit (MRU) within the Licensing and Compliance Division. The current procedural guidance is Guidance on Application for Free Sale Certificate of Pharmaceutical Product and Certificate of Pharmaceutical Product (DO 05/2023), published by the Pharmacy and Poisons Board.

For the full statutory text, consult the Hong Kong e-Legislation website (Cap. 138A). The guidance notes state they are a general guide only and not a complete or authoritative statement of law for any particular case.

CPP vs FSC: comparison table

Both certificates relate to registered pharmaceutical products manufactured by licensed manufacturers, but they serve different export purposes:

You may apply for one certificate type per product on a single submission. If you need certificates for more than three products, provide additional product details on a separate sheet as specified in the application appendix.

Relationship to HK-XXXXX product registration

Product registration and CPP/FSC certification are separate processes under Hong Kong pharmaceutical law:

When a medicine is approved for registration, DH assigns an HK-XXXXX registration number that must appear on sales packs. The Compendium of Pharmaceutical Products on the Drug Office website lists registered product names, active ingredients, and registration holders — use it to verify registration numbers before applying for CPP/FSC.

CPP and FSC are not substitutes for registration. An exporter cannot obtain a CPP or FSC for an unregistered product. Conversely, holding an HK-XXXXX registration does not automatically issue a CPP or FSC — the manufacturer must submit a separate application with the product registration number in Part B of the form.

If your product is not yet registered, start with the pharmaceutical product registration pathway (new drug, generic, or other applicable route) before applying for export certificates.

Who must apply

The manufacturer of the pharmaceutical product must submit the application. This is stated explicitly in Part A of the application appendix: "The application should be submitted by the manufacturer of the pharmaceutical product."

Manufacturer is also the registration certificate holder

Complete Part A with manufacturer name (English and Chinese), address, telephone, fax, and business email. Confirm in Part A that the applicant is the holder of the certificate of registration.

Manufacturer is not the registration certificate holder

If the applicant manufacturer is not the registration certificate holder, select No in Part A and submit an authorization letter from the certificate holder authorising the manufacturer to apply for the CPP or FSC on their behalf.

Licensed manufacturer requirement

Reg 29 certificates are available for pharmaceutical products manufactured by a licensed manufacturer. The manufacturing site must hold a valid Licence for Manufacturer of Pharmaceutical Products under Cap. 138A. Export certificate applications are handled by the same MRU that oversees GMP and manufacturer licensing — contact gmp@dh.gov.hk for procedural questions.

Step-by-step application workflow

Step 1 — Confirm eligibility

Before preparing the application, verify:

1. The product holds a valid HK-XXXXX registration number (check the Compendium or registration certificate).
2. The applying entity is the licensed manufacturer of that product at the site of manufacture stated in the registration dossier.
3. You know whether the importing country requires an FSC (free sale proof) or a WHO-format CPP — request the wrong type and destination authorities may reject the dossier.
4. If the manufacturer is not the registration holder, an authorization letter from the certificate holder is ready.

Step 2 — Complete the application form (Appendix, DO 05/2023)

The combined application form has three parts:

Part A — Details of applicant

• Manufacturer name (English and Chinese)
• Manufacturer address
• Telephone, fax, business email
• Confirmation whether applicant is registration certificate holder (if No, attach authorization letter)

Part B — Application details

• Select certificate type: FSC or CPP
• For each product (up to three on the form):
  • Name of pharmaceutical product
  • Product registration number (HK-XXXXX)
  • Number of certificate(s) required
• For more than three products, attach a separate sheet with the same fields

Part C — Declaration

• Declare information is true and correct
• Authorised signatory name, position, company name
• Signature, date, and company stamp

Step 3 — Prepare payment

• FSC: HK$180 per application (per guidance §2)
• CPP: HK$140 per application (per guidance §3)

Confirm current payment methods with MRU when submitting — the guidance specifies the fee amounts; payment instructions may accompany the e-Form or paper submission.

Step 4 — Choose submission route

Submit the completed form by any of the following routes:

The e-Form is listed on DH's Useful Forms page under healthcare products. Access the portal at the Drug Office e-cert login page (drugoffice.gov.hk pharmaceutical trade eform section).

Step 5 — Track processing against performance pledges

DH performance pledges (clock starts upon receipt of all required documents):

Incomplete applications — missing authorization letters, wrong registration numbers, unsigned declarations, or absent company stamps — do not start the pledge clock until MRU confirms a complete file.

Step 6 — Receive certificate and distribute to importing country

Upon approval, use the issued certificate in the destination country's import or registration dossier. Some authorities require legalisation or apostille — confirm with the importing regulator; that step is outside MRU's scope.

Key documents and what they must contain

MRU may request supplementary GMP or manufacturing evidence if the product's registration or licence status is unclear. Maintain alignment between the product name and registration number on the application and the Compendium entry.

MRU contact and office hours

For personal data access enquiries related to licence applications, the guidance directs enquiries to the Senior Pharmacist at the same address (Tel: 2961 8028).

Checklist

• Product registered in Hong Kong with valid HK-XXXXX number verified in Compendium
• Applicant is the licensed manufacturer of the product
• Correct certificate type selected (FSC vs CPP) based on importing country requirements
• Application form Parts A, B, C completed with company stamp
• Registration certificate holder authorization letter attached (if manufacturer ≠ certificate holder)
• Separate product sheet attached if >3 products on one application
• Fee prepared: HK$180 (FSC) or HK$140 (CPP)
• Submission route chosen: e-cert e-Form, email, post, fax, or in person
• Product names and HK numbers match registration certificate exactly
• Destination country requirements for legalisation/apostille checked

Common pitfalls

1. Confusing CPP/FSC with registration — HK-XXXXX registration is a separate process; export certificates cannot be issued for unregistered products.
2. Wrong applicant entity — Only the manufacturer may submit; marketing authorisation holders who are not manufacturers must provide an authorization letter and have the manufacturer file.
3. Registration number mismatch — Part B registration numbers must match the Compendium and sales-pack labelling exactly; typos delay processing.
4. Selecting the wrong certificate type — FSC proves free sale in HK; CPP follows WHO format for registered products. Destination regulators often specify which they require.
5. Incomplete declaration — Missing signature, date, or company stamp in Part C prevents MRU from treating the file as complete.
6. Assuming the pledge starts on submission — The 7-day (FSC) and 12-day (CPP) clocks start only upon receipt of all required documents, not on partial submissions.
7. More than three products without attachment — List only three products on the main form; attach a separate sheet for additional products as instructed.
8. Unlicensed manufacturing site — Reg 29 applies to products from licensed manufacturers; expired or absent manufacturer licences block certificate issuance.

FAQ

What is the difference between CPP and FSC in Hong Kong?

The FSC confirms a registered pharmaceutical product may be sold freely in Hong Kong and is commonly used when importing countries request proof of local marketing status. The CPP is issued in WHO certificate format for registered products manufactured in Hong Kong and is typically required for formal product registration or import approval in WHO-member and aligned markets. Both are issued under Reg 29, Cap. 138A by the Drug Office MRU, but they serve different export documentation purposes.

Who can apply for a CPP in Hong Kong?

The manufacturer of the pharmaceutical product must submit the application to MRU. If the manufacturer is not the registration certificate holder, an authorization letter from the certificate holder is required. The product must be registered in Hong Kong (HK-XXXXX) and manufactured by a licensed manufacturer. Marketing authorisation holders, distributors, or overseas agents cannot apply directly unless they are also the licensed manufacturer.

How long does the Drug Office take to issue a CPP?

The Department of Health performance pledge for a Certificate of Pharmaceutical Product (CPP) is 12 working days upon receipt of all required documents. The pledge for a Free Sale Certificate (FSC) is 7 working days. Incomplete applications — missing stamps, authorization letters, or incorrect registration data — delay the start of the processing clock.

What is the fee for a free sale certificate in Hong Kong?

The fee for a Free Sale Certificate of Pharmaceutical Product (FSC) is HK$180. The fee for a Certificate of Pharmaceutical Product (CPP) is HK$140. Fees are set out in the Drug Office guidance DO 05/2023 (§2 for FSC, §3 for CPP). Confirm payment method with MRU at submission.

Is CPP the same as product registration in Hong Kong?

No. Product registration grants marketing approval and assigns an HK-XXXXX number under Cap. 138. A CPP is an export certificate under Reg 29, Cap. 138A confirming that an already-registered product is manufactured by a licensed Hong Kong manufacturer. You must complete registration first, then apply separately for CPP or FSC when an importing country requires export certification.

Can I submit a CPP or FSC application online?

Yes. The Drug Office provides an Application e-Form for Free Sale Certificate of Pharmaceutical Product / Certificate of Pharmaceutical Product through the e-cert portal on the Drug Office website. Online submission requires a digital certificate for portal login. Alternatively, submit by email (gmp@dh.gov.hk), post, fax (3904 1225), or in person at MRU, Revenue Tower, Wan Chai.

What registration number format should I enter on the application?

Enter the Hong Kong medicine registration number in HK-XXXXX format — the letter prefix HK- followed by a five-digit number assigned upon registration approval. This number must appear on the product's sales packs and match the entry in the Compendium of Pharmaceutical Products. Each product listed in Part B of the application requires its own registration number.

What is the "COS application" for pharmaceutical products in Hong Kong?

Search queries referring to "COS application" or certificate of pharmaceutical product in Hong Kong typically map to the CPP (Certificate of Pharmaceutical Product) application under Reg 29. This is distinct from Certificate of Suitability (CEP) applications in the EU context. In Hong Kong, use the combined FSC/CPP application form (DO 05/2023) and select Certificate of Pharmaceutical Product in Part B.

Official sources

• Pharmacy and Poisons Board — Guidance on Application for Free Sale Certificate of Pharmaceutical Product and Certificate of Pharmaceutical Product (DO 05/2023): https://www.ppbhk.org.hk/eng/files/Guidance_on_Application_for_FSC_and_CPP_EN.pdf
• Department of Health — Useful Forms (FSC/CPP e-Form; gmp@dh.gov.hk; Tel 2594 7647): https://www.dh.gov.hk/english/useful/useful_forms/useful_forms.html
• Department of Health — Performance Pledges (FSC 7 working days; CPP 12 working days): https://www.dh.gov.hk/english/aboutus/aboutus_pp/aboutus_pp.html
• Department of Health — Registered medicines and HK-XXXXX registration numbers: https://www.dh.gov.hk/english/useful/useful_registration/useful_registration.html
• Drug Office — e-cert portal login for online FSC/CPP e-Form submission: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/eform/ecert_login.html
• Hong Kong e-Legislation — Pharmacy and Poisons Regulations (Cap. 138A), Regulation 29: https://www.elegislation.gov.hk