Thien Di provides services for issuing certificates of cosmetic registration in 2024.

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1. Definition of Cosmetics and Cosmetic Declaration:

According to Clause 1, Article 2 of Circular 06/2011/TT-BYT, a cosmetic product is any substance or preparation intended to be placed in contact with the external parts of the human body (skin, hair system, nails, lips, and external genitalia) or teeth and oral mucous membranes for the purpose of cleansing, perfuming, changing appearance, adjusting body odor, protecting the body, or keeping the body in good condition.

Cosmetic declaration is the process by which an organization or individual that produces or imports cosmetics completes procedures with the competent state management agency to obtain a cosmetic product declaration receipt number before placing the product on the market. The declarant is fully responsible for the safety, efficacy, and quality of the product.

2. What is a Cosmetic Declaration Registration Certificate?

The Cosmetic Declaration Registration Receipt Number is a number issued by the competent state management agency upon receiving the cosmetic product declaration dossier. The Declaration Receipt Number serves as a certificate that the cosmetic product has been declared by the organization or individual responsible for putting the product on the market to the competent state management agency regarding the circulation of the cosmetic product on the market, but does not certify that the product is safe, effective, and meets all the requirements of the ASEAN Cosmetic Agreement and its Annexes (Clause 4, Article 2 of Circular 06/2011/TT-BYT).

3. Why is it necessary to register for cosmetic circulation declaration?

The declaration of cosmetic quality in each country, especially the declaration of imported cosmetics before circulation, contributes to ensuring the quality of the product before it reaches consumers. It is an important legal basis for determining the responsibility of the manufacturing and trading units when there are risks to the health of consumers, and it is also an act of protecting consumers from counterfeit cosmetic products.

4. Guidelines for Procedures and Documents for Applying for a Cosmetic Declaration Certificate in 2022

Legal Framework:

Circular No. 06/2011/TT-BYT dated January 25, 2011, on the management of cosmetics.
Circular No. 29/2020/TT-BYT dated December 31, 2020, amending, supplementing, and repealing a number of legal documents issued by the Minister of Health and jointly issued.
Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of regulations related to investment and business conditions under the state management of the Ministry of Health.

4.1. Cosmetic Product Registration Declaration Dossier

The dossier for domestically manufactured cosmetics consists of the following documents:

Domestic Cosmetics:

For domestically produced cosmetics, the declaration dossier includes the following documents:

General Cosmetic Declaration Form
Original or notarized copy of the Authorization Letter from the manufacturer or product owner authorizing the organization or individual responsible for bringing the product to the market to distribute cosmetic products in Vietnam (applicable to domestically produced cosmetics where the organization or individual responsible for bringing the product to the market is not the manufacturer)
CD containing the declaration dossier (soft file of the declaration form)

Imported Cosmetics:

The declaration dossier for imported cosmetics includes the following documents:

(i) Imported Cosmetic Declaration Form (according to the prescribed form);

(ii) Business registration certificate of the entity named in the declaration dossier (notarized copy) - Business registration content includes manufacturing and trading of cosmetics;

(iii) Certificate of Free Sale (CFS) issued by the country of origin must be an original or a notarized copy, still valid. If the CFS does not specify a validity period, it must be issued within 24 months from the date of issue.

(iv) The Power of Attorney must be notarized and consularized according to legal regulations, except in cases exempted from consularization under international treaties to which Vietnam is a member. The Power of Attorney must meet the requirements specified in Article 6 of this Circular.

Note:

Cases exempted from CFS include:

Cosmetic products manufactured in a member country of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) whose participation in this Agreement has been ratified and entered into force by the competent authority of that country (hereinafter referred to as the CPTPP member country)
Cosmetic products circulated and exported from a CPTPP member country
Cosmetic products that have been granted a reception number for the Cosmetic Product Declaration Form in a country belonging to the Association of Southeast Asian Nations (ASEAN)

4.2 Procedure for receiving a notification number for a cosmetic declaration form

The procedure for receiving a notification number for a cosmetic declaration form is as follows:

Step 1: Prepare the cosmetic declaration dossier

The cosmetic declaration dossier must be prepared in one set with the components listed above and submitted to the competent state management agency.

Step 2: Submit the cosmetic declaration dossier to the competent state management agency

For a domestic cosmetic declaration dossier: Submit to the organization or individual responsible for bringing the product to the market at the Department of Health where the manufacturing plant is located. Cosmetics manufactured and packaged from imported semi-finished products are considered domestic products.
For an imported cosmetic declaration dossier: Department of Drug Administration - Ministry of Health.

Step 3: Submission method:

For domestic cosmetic declaration dossiers: Submit online and send the original dossier by post to the receiving agency.
For imported cosmetic declaration dossiers: Submit online through the National Single Window Portal system.

Step 4: Review and evaluate the cosmetic declaration dossier

Within 03 working days from the date of receiving a valid declaration dossier and the prescribed declaration fee, the competent state management agency shall be responsible for issuing a notification number for the Cosmetic Declaration Form.
If the declaration dossier does not meet the requirements of this Circular, within 05 working days from the date of receiving the dossier, the receiving agency shall notify the organization or individual making the declaration in writing of the contents that do not meet the requirements for amendment and supplementation of the dossier (specifically stating the contents that do not meet the requirements).

Within 03 months from the date of issuance of the notification document as prescribed in point b of this clause, if the competent state management agency does not receive the supplementary dossier from the organization or individual declaring, the declaration dossier will be invalid. In this case, if the organization or individual wants to continue the declaration, they must submit a new dossier and pay a new fee as prescribed.

However, in practice, the dossier processing time is often longer. For domestic cosmetic declaration dossiers, the processing time is usually 10-15 working days; for imported cosmetic declaration dossiers, it will usually take 20-25 working days.

Step 5: Issue a notification number for the Cosmetic Declaration Form when the dossier is valid

After completing all the procedures mentioned above and being issued a notification number for the Cosmetic Declaration Form, the organization or individual responsible for bringing the cosmetic product to the market will be allowed to legally circulate the cosmetic products that they manufacture, trade, and distribute.

5. Not registering cosmetic products before putting them on the market will result in penalties.

According to Article 68 of Decree 117/2020/ND-CP dated September 28, 2020, the act of distributing cosmetic products without obtaining a registration number from the competent state agency will be subject to a fine of between 20,000,000 VND and 30,000,000 VND.

In addition to the main penalty of a fine, there will be additional penalties, including:

Suspension of business activities related to cosmetic products for a period of 03 to 06 months.

Remedial measures:

The violator must recall and destroy all non-compliant cosmetic products.

Therefore, it is crucial to register your cosmetic products before launching them in the market to avoid legal consequences.

6. Looking up the Acceptance Number of a Cosmetic Declaration Form

The need to look up the acceptance number of a cosmetic declaration form usually arises when importing cosmetic products, as customs authorities may require this information for inspection upon arrival of the goods.

To look up the acceptance number of a cosmetic declaration form, businesses can access the following link provided by the Department of Drug Administration under the Ministry of Health:http://103.124.60.71:8002/Pages/lookupCosPermitManager.zul

7. Thiên Di - A Fast and Reputable Cosmetics Notification Service Provider

Thiên Di is a consulting company that provides comprehensive solutions for businesses in the production and registration of cosmetics in Vietnam. Our cosmetics notification service ensures a quick, cost-effective, and reputable process with a validity of 5 years.

7.1. Thiên Di's cosmetics notification service includes:

Receiving your information and requests for cosmetics circulation notification and quality assurance.
Checking the legality and validity of related documents.
Consulting and amending inaccurate documents to meet current legal requirements.
Drafting legal documents for cosmetics notification.
Submitting your notification dossier to the Department of Pharmacy under the Ministry of Health of Vietnam, or the Department of Health of provinces and cities.
Monitoring the dossier processing progress.
Receiving the notification results and delivering them to you.

7.2. Reasons to Choose Thiên Di's Services:

We are committed to providing timely and enthusiastic support to our clients in all situations.
Our team consists of highly qualified and experienced professionals who have undergone formal training.
We stay updated on the latest regulations and policies and regularly participate in training courses to improve our professional qualifications and work experience.
We are capable of handling high work pressure and delivering results under tight deadlines.
We are dedicated to continuous self-improvement and professional development, aiming for absolute customer satisfaction.

7.3. Staff

The human resources are the key to the success of each enterprise. Therefore, Thiên Di always focuses on building and developing professional, dedicated, and customer-friendly human resources - that is the compass for our success over the past time.

Thiên Di provides cosmetic and imported cosmetic declaration services in Vietnam. Currently, we provide this service in most provinces and cities across the country. We complete the cosmetic declaration dossier and procedures, represent customers to submit the cosmetic declaration dossier to the state agency, so customers will not have to spend time doing administrative procedures.

Contact Info:

THIEN DI TRADING SERVICES COMPANY LIMITED

Address: No. 36 Street A4, Ward 12, Tan Binh District, Ho Chi Minh City

Hotline: 0981317075

Phone: 028.6293 9377
Email: info@luatthiendi.com