10 QUESTIONS ABOUT PREPARATION REGISTRATION IN VIETNAM

In the household and medical sectors, bactericidal and insecticidal preparations have been and continue to be extremely common not only in Vietnam but also around the world. Recently, many businesses have chosen preparations for development as a result of the Covid situation. However, not all companies are aware of the need for planning registration. Hence, Doanh Tri law firm provides the following article “10 questions about preparation registration in Vietnam”.

I. Legal basis

- Law on Chemicals dated November 21, 2007;

- Law on Product and goods quality dated November 21, 2007;

- Law on Enterprises dated June 17, 2020;

- Commercial Law dated June 14, 2005;

- Law on Technical Standards and Regulations dated June 29, 2006;

- Decree No. 91/2016/ND-CP dated July 1, 2016, of the Government on the management of insecticidal and germicidal chemicals and preparations for household and medical use.

- Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing a number of provisions related to business investment conditions under the state management scope of the Ministry of Health;

- Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance regulating the rate, regime of collection, payment, management, and use of fees in the health sector;

- Decision No. 5083/QD-BYT announcing the amended and supplemented administrative procedures in the field of health environment management under the management of the Ministry of Health specified in Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government.

II. 10 questions about preparation registration in Vietnam

1. Which agency has the authority to receive a dossier for registration of preparations?

Enterprises wishing to sell insecticidal and germicidal preparations for household and medical usage must apply to the Ministry of Health's Department of Health Environment Management.

2. What types of entities are permitted to register for the distribution of preparations?

According to Article 20 of Decree No. 91/2016/ND-CP, the organization is allowed to register for circulation:

1. Enterprises permitted to register for free sale of preparations include:

a) Domestic enterprises, cooperatives, or business households that are the owners of preparations or representative offices of foreign traders in Vietnam in which those traders are the owners of preparations;

b) Domestic enterprises, cooperatives, and business households authorized to register by the owner of preparations;

c) Representative offices of foreign traders in Vietnam authorized by the owner of preparations.

2. In case of additional registration, an extension of circulation registration number, and re-issuance of a sale registration certificate, the establishment entitled to the registration of free sale shall be the holder of the registration number.

3. In cases where the owner of preparations allows the authorized establishment to continue authorizing another establishment to register the preparations, the contents of the authorization for re-authorization must be specified in the Power of Attorney.

3. What are the requirements for preparations when registering for circulation?

According to Article 19 of Decree No. 91/2016/ND-CP: Conditions for preparations for circulation

- Toxicity of preparations not in groups Ia, Ib according to the classification of the World Health Organization for insecticidal preparations or groups I, II according to the classification of the Globally Harmonized System of Classification and Chemical label - GHS.

- Does not contain active ingredients on the list of prohibited substances from use in preparations.

- Preparations containing active ingredients on the list of restricted use scope in preparations may only register for circulation with the prescribed scope of use.

- It is produced at a facility that has announced the eligibility to produce (for domestically manufactured preparations) or has a Certificate of Free Sale (for imported preparations).

4. What kinds of documents are included in a dossier?

The dossier includes:

- A written request for new circulation registration, made according to Form No. 04 in Appendix I to Decree No. 91/2016/ND-CP.

- Papers on the legal person status of the registration establishment or manufacturer.

- A power of attorney for registration of the circulation, except for the case specified at Point a, Clause 1, Article 20 of Decree No. 91/2016/ND-CP.

- Technical documents of inoculants requested for registration include the contents specified in Appendix V issued together with Decree No. 91/2016/ND-CP.

- Results of testing the composition and content of active ingredients in the preparation (to be added with the answer sheet of testing results)

- Answer form of testing results (to be supplemented after the Health Ministry has issued written permission for testing).

- Label sample of preparations.

- Certificate of free sale (for imported preparations).

- Documents, research results on safety and efficacy or recommendations of the World Health Organization or equivalent international organizations on the use of preparations in the domestic and medical sectors (for preparations containing active ingredients or in the form of products registered in Vietnam for the first time).

5. What is the procedure of preparations registration?

Step 1: Establishments registering for circulation insecticidal and germicidal preparations for household and medical use shall submit their dossiers to the Health Environmental Management Department, the Ministry of Health.

Step 2: After receiving the new application for registration and the fee for examining the application for testing, the Department of Health Environment Management, the Ministry of Health shall send the application form to the applicant. 04 of Appendix III attached to the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date on the Receipt note, the Department of Health Environment Management, the Ministry of Health shall notify in writing the new registration establishment of the request for amendment, Supplement records or permit or disallow assays.

If there is a request to supplement or amend the dossier, within 90 days from the date stated in the registration document, the registration establishment must complete the dossier, clearly explain the supplemented or modified contents in writing and send it to the Department of Health Environment Management, the Ministry of Health.

Step 4: If there is no longer a requirement for amendments or supplements, the Department of Medical Environment Management, the Ministry of Health, must notify the applicant in writing of whether or not to allow testing.

Step 5: After having written permission for testing, the applicant is responsible for completing the testing and testing in accordance with Chapter II of Decree No. 91/2016/ND-CP and submitting the test results. and conduct testing to add to the dossier together with the fee for appraisal of the new circulation registration dossier within 12 months from the date stated on the official dispatch permitting the testing.

Step 6: Within 30 days from the date on the Receipt note, the Department of Health Environment Management, the Ministry of Health shall notify the applicant in writing of the request for amendments and supplements to the application. preliminary, not issuing circulation registration numbers or granting circulation registration numbers.

6. What is the address of the Ministry of Health's Department of Health Environment Management?

Address: Lane 8, Ton That Thuyet, My Dinh 2, Nam Tu Liem, Hanoi

Phone: (+84) 024 32272861

Fax: (+84) 024 32272858

Hotline: (+84) 02432272861

7. Is it necessary to submit a dossier in person?

No. It can be mailed OR submitted directly to the Department of Environmental Health Management. If the Department of Health Environment Management, the Ministry of Health implements the online announcement, the publisher shall submit the online application.

8. How long does the procedure take?

- Within 30 days from the date of receipt of a complete application, the Department of Health Environment Management, the Ministry of Health shall notify in writing the new free sale registration establishment of the request for supplementation or amendment of the application. either allow or disallow testing.

- Within 30 days from the date of receipt of the written response to the testing results and the component testing results of the registrar for addition to the dossier, the Department of Health Environment Management, the Ministry of Health to notify in writing the registration establishment of the request for supplementation or modification of dossiers, not to grant circulation registration numbers or to grant circulation registration numbers.

9. How much would it cost to get a dossier verified?

According to Circular 11/2020/TT-BTC amending and supplementing various articles of circular no. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance, payment, management and use of fee in the medical sector, the new assessment fee is millions VND.

10. What is the procedure for importing preparations?

The procedures for licensing the import of insecticidal and germicidal preparations for domestic and medical use are specified in Article 50 of the Government's Decree No. 91/2016/ND-CP.

Accordingly, the individuals and organizations will do the following:

- The importer (hereinafter referred to as the importer for short) shall submit the application directly or by post to the Ministry of Health (the Department of Health Environment Management). If the Ministry of Health implements the online issuance of the import license, the organization or individual shall submit an online application.

- After receiving the application for an import permit, the Ministry of Health shall send to the organization or individual requesting the import the receipt of an application for an import license. The form of the law's form of receipt of the application for import.

- In case there is no request for supplementation or modification to the application for import, the Ministry of Health shall issue an import license. In case of refusal, there must be a written reply clearly stating the reason.

- In case the dossier of application for import is incomplete, the Ministry of Health must notify the importer in writing to supplement or amend the dossier within 15 days from the date stated on the dossier receipt. application for import. The written notice must clearly state the content to be supplemented or modified.

- In case the Ministry of Health sends a written request for supplementation or modification of the dossier, within 60 days from the date stated in the document, the importer must complete the dossier and clearly explain the additional contents Supplement, amend in writing and send to the Ministry of Health. The date of receipt of the supplemented or modified dossier is specified on the dossier receipt. If the above time limit is exceeded, the application for import will be canceled.

- Within 03 working days from the date of issuance of the import license, the Ministry of Health shall publish on its website the following information:

+ Name of the preparation;

+ Import license number;

+ Full text of import license.

The above information is about the "10 questions about preparation registration in Vietnam". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

Email: luatdoanhtri@gmail.com

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