Cosmetics

COSMETICS EXPORTS – WHAT SHOULD BUSINESSES PAY ATTENTION TO?

In today’s increasingly globalized environment, exporting cosmetics has become an essential trend for Vietnamese enterprises. However, complying with legal documentation requirements is mandatory to ensure smooth customs clearance and to build credibility in international markets. In this article, MEDGATE will guide you through the procedures for obtaining the Certificate of Free Sale (CFS) and the CGMP-ASEAN certification – both essential for cosmetic exports.

1. Procedure for Obtaining the Certificate of Free Sale (CFS)

The application dossier for a CFS for domestically manufactured cosmetic products includes:

  • Application Form for CFS (as per Appendix IV of Decision No. 10/2010/QĐ-TTg dated February 10, 2010 by the Prime Minister) – must be fully and accurately completed. 
  • Copy of the Product Notification Form that has been granted a reference number, signed and sealed by the requesting enterprise. 

Important Notes:

  • Exporting companies must register their business profile with the Department of Health in the locality where the manufacturing facility is located before submitting a CFS application. 
  • One CFS can cover one or multiple products (using the template in Appendix 12-MP) and is valid for 2 years from the date of issuance. 
  • CFS issuance fees and charges are applied in accordance with current regulations and calculated based on each product with a corresponding Product Notification Form. 
  • The CFS is issued by the local Department of Health and is managed according to the jurisdiction of the manufacturing facility. 

2. CGMP-ASEAN Certification

To demonstrate that a manufacturing facility complies with ASEAN Guidelines on Good Manufacturing Practices for Cosmetics (CGMP-ASEAN)—a key requirement for export—the following documents must be prepared:

  • Application Form for CGMP-ASEAN Inspection (Appendix 13-MP) 
  • Copy of the Business Registration Certificate or Investment License 
  • Organizational structure and staffing chart, clearly identifying key personnel in departments such as production, quality control, quality assurance, and warehousing. 
  • Training program and implementation results of CGMP at the facility. 
  • Factory layout diagram, showing material flow, personnel movement, and finished goods route. 
  • List of equipment, including both manufacturing and quality control equipment, specifying name, year of manufacture, origin, and current condition. 
  • List of current and planned cosmetic products to be produced. 
  • Internal audit report on CGMP compliance, including corrective action plans for any identified deficiencies. 

Procedure:

  • Submit the dossier to the Drug Administration of Vietnam – Ministry of Health. 
  • The Administration will evaluate the documents, form an inspection team, and notify the enterprise at least 10 days in advance. 
  • If all requirements are met, the facility will be granted the CGMP-ASEAN Certificate, valid for 3 years, upon completion of the required appraisal fee. 

3. Key Notes for Document Preparation

  • The CFS application form must be accurately filled and consistent with the product notification form. It must follow Appendix IV of Decision No. 10/2010/QĐ-TTg. 
  • The CFS must be issued only for products that have been officially notified, including the reference number, as stipulated in Chapter II of Decision 10. 
  • Registering the business profile is mandatory under Article 9 of Decision 10 and must include: a copy of the Business Registration Certificate, tax code, authorized signature samples, and list of manufacturing facilities. 
  • CGMP-ASEAN compliance must be supported by sufficient documentation, diagrams, equipment lists, and training certificates to meet inspection requirements by the Drug Administration. 
  • Fees for CFS and CGMP-ASEAN certification must be updated regularly based on the latest legal provisions to avoid any oversight. 

Summary Checklist:

✔ Product Notification Form and Business Profile Registration must be completed before applying for a CFS.
 ✔ CGMP-ASEAN dossier must be comprehensive and supported by tangible evidence.
 ✔ CFS is valid for 2 years and only applies to notified products.
 ✔ CGMP-ASEAN certificate is valid for 3 years and must be renewed before expiration.

A complete and properly prepared export dossier not only expedites the delivery of goods to international partners but also strengthens transparency, legal compliance, and corporate reputation.

For consultation on registration services for medical devices, functional foods, cosmetics, and dietary supplements in compliance with current regulations, please contact us via hotline: 098.546.1894.