Cosmetics Production Eligibility Certificate Procedure

The Cosmetics Production Eligibility Certificate is a mandatory legal process. All organizations and businesses must complete this before factory operation. This process is strictly regulated. It ensures the cosmetics production facility complies with standards for personnel, facilities, and quality management systems as required by the Ministry of Health. This Long Phan Consulting Company article analyzes the conditions, dossiers, and procedures for this legal process.

Conditions for the Cosmetics Production Eligibility Certificate

The procedure is detailed in Sub-item 1, Section B1, Part II, Decision No. 7866/QD-BYT 2018. To be certified, the production facility must strictly meet requirements. The core conditions for a new certificate focus on three main groups:

Personnel Condition: The person in charge of production must have professional knowledge in one of the following fields: chemistry, biology, pharmacy, or other relevant disciplines that meet the job’s requirements.

Facility Condition:

• Must have a location, area, factory, and equipment that match the requirements of the production line and the cosmetic product types the facility intends to produce (as stated in the application).
• The warehouse for raw materials, packaging, and finished goods must ensure separation. It must have separate areas for flammable/explosive substances, highly toxic substances, and rejected, recalled, or returned materials and products.

Quality Management System:

• Raw materials, excipients, and semi-finished products used in cosmetic production must meet the manufacturer’s quality standards.
• Water used in production must, at minimum, meet the national technical standards for drinking water issued by the Ministry of Health.
• Must have a specific production process for each product.
• Must have a quality control department to inspect the quality of raw materials, semi-finished products, products awaiting packaging, and finished products.

>>> See more at: Cosmetics business code: Selection guide

Competent Authority for Certification

According to Sub-item 1, Section B1, Part II, Decision No. 7866/QD-BYT 2018 and specified in Article 5, Decree No. 93/2016/ND-CP, the administrative body for this procedure is the provincial-level Department of Health (Sở Y tế) where the factory is located.

The Department of Health has comprehensive responsibility throughout the process, from receiving the dossier to issuing the Cosmetics Production Eligibility Certificate. It is the specialized agency under the provincial People’s Committee, managing state functions for health, pharmaceuticals, and cosmetics locally.

Dossier for the Cosmetics Production Eligibility Certificate

According to Article 7, Decree No. 93/2016/ND-CP, one (01) complete dossier set for a new certificate includes:

• Application Form: This must follow Form No. 02 (issued with Decree No. 93/2016/ND-CP). The form must include full information on the facility, the legal representative, the production manager, and a commitment to comply with legal regulations.
• Facility Layout and Design: This diagram must clearly show the arrangement of functional areas: material reception, production, packaging, quality control, warehouses (raw materials, finished goods), water treatment system, waste treatment system, and other auxiliary areas. The layout must be logical and follow a one-way principle to prevent cross-contamination.
• List of Existing Equipment: This list must detail all machinery and equipment at the factory used for the production line and quality control. Information includes equipment name, model, country of origin, year of manufacture, operational status, and function. This list demonstrates the facility’s actual production capacity and ensures equipment suitability for the registered products.

>>> See more at: Steps to apply for a Cosmetic Advertising License

Procedure for the Cosmetics Production Eligibility Certificate

The procedure is clearly defined in Sub-item 1, Section B1, Part II, Decision No. 7866/QD-BYT 2018 (and specified in Article 9, Decree No. 93/2016/ND-CP). Understanding these steps helps businesses proactively manage the process.

The procedure for the Cosmetics Production Eligibility Certificate follows these steps:

• Step 1: Before starting production, the facility submits the application dossier to the Department of Health.
• Step 2: Within 02 working days of receipt, the Department of Health checks the dossier. It issues a Dossier Receipt Note (Form No. 05, Decree No. 93/2016/ND-CP) if the dossier is complete and valid. If the dossier is incomplete or invalid, the facility is notified in writing of the deficiencies.
• Step 3: Within 30 days of receiving a valid dossier and the appraisal fee, the Department of Health inspects the facility and issues the Cosmetics Production Eligibility Certificate. If it does not issue the certificate or requests changes/corrections, it must provide a written notice stating the reasons.
  • For Correction Requests:
    • The facility makes the required changes and submits a report to the Department of Health.
    • The Department of Health reviews the report (or re-inspects the facility if necessary) and must respond in writing within 15 days of receiving the report.
  • For Facilities with CGMP-ASEAN:
    • The Ministry of Health sends an official letter to the provincial Department of Health regarding the issuance of the Cosmetics Production Eligibility Certificate.
    • The Department of Health then issues the certificate to these facilities.

>>> See more at: What does an application for a cosmetics business license include?

Required Fees for Certification

According to Circular No. 41/2023/TT-BTC (Ministry of Finance), the appraisal fee for a new Cosmetics Production Eligibility Certificate is 6,000,000 VND (Six million VND) per appraisal. The enterprise must pay this fee to the Department of Health after the dossier is confirmed as valid and before the inspection team conducts the on-site visit.

Timely payment of the appraisal fee is necessary for the Department of Health to proceed with the certification steps.

Service for the Cosmetics Production Eligibility Certificate Procedure

The Cosmetics Production Eligibility Certificate procedure requires specialized legal knowledge and practical experience. This complex process ranges from facility construction to dossier preparation. To optimize time and ensure success, using a professional consulting service is an effective solution.

Long Phan Consulting Company provides comprehensive support, assisting clients through the entire procedure, including:

• Assisting in reviewing and advising clients on factory design and production line layout to ensure strict legal compliance.
• Guiding the development and finalization of management processes, production processes, and quality control systems.
• Ensuring the personnel, especially the production manager, meet all professional qualification requirements mandated by law.
• Assisting in the preparation and completion of the entire dossier, including the Application Form and other documents, per Department of Health standards.
• Reviewing and ensuring the accuracy and validity of technical documents, such as layout diagrams and equipment lists.
• Performing a final check of the dossier before submission to minimize the risk of rejection or requests for supplementation.
• Representing the client in working directly with the Department of Health to submit the dossier and handle administrative transactions.
• Closely monitoring the dossier processing status, providing updates, and handling supplementary requests from authorities on the client’s behalf.
• Assisting and working with the appraisal team during the on-site inspection until the client officially receives the Cosmetics Production Eligibility Certificate.

Frequently Asked Questions (FAQ)

Below are frequently asked questions about the Cosmetics Production Eligibility Certificate procedure.

Which agency has the authority to issue the Cosmetics Production Eligibility Certificate?

The provincial-level Department of Health (Sở Y tế) where the factory is located has the authority to receive dossiers, appraise, and issue the certificate. Legal basis: Article 5, Decree No. 93/2016/ND-CP.

What main documents are required in the application dossier?

A complete dossier includes 03 main documents: The Application Form (Form No. 02), the facility layout and design diagram, and the list of existing equipment. Legal basis: Article 7, Decree No. 93/2016/ND-CP.

What is the timeline for the Department of Health to issue the certificate after receiving a valid dossier?

Within 30 days of receiving a valid dossier and the appraisal fee, the Department of Health is responsible for inspecting the facility and issuing the certificate. Legal basis: Article 9, Decree No. 93/2016/ND-CP.

What is the appraisal fee for the Cosmetics Production Eligibility Certificate?

The appraisal fee for a new certificate is 6,000,000 VND (Six million VND). Legal basis: Circular No. 41/2023/TT-BTC.

What professional conditions must the production manager meet?

The production manager must have professional knowledge in one of the following fields: chemistry, biology, pharmacy, or other relevant disciplines that meet the job’s requirements. Legal basis: Decision No. 7866/QD-BYT 2018.

Conclusion

The Cosmetics Production Eligibility Certificate procedure demands strict adherence to legal conditions and processes. To ensure this process is smooth and accurate, clients should seek a professional consulting unit. With specialized experience, Long Phan Consulting Company is ready to help clients complete the procedure quickly and effectively. Please contact the hotline 1900636389 for detailed advice.