Fee for issuance of registration certificate for circulation of medicinal drugs

Issuance of registration certificate for circulation of medicinal drugs is a mandatory legal procedure for pharmaceutical businesses that want to bring products to market. This process ensures that herbal medicines meet quality, safety and effectiveness standards according to regulations of the Ministry of Health. The following article will provide detailed information about the conditions, processes and costs related to this procedure.

Conditions for issuance of registration certificate for circulation of medicinal drugs

To be granted a registration certificate to circulate medicinal drugs, pharmaceutical enterprises must meet a number of specific conditions. These requirements are intended to ensure the quality and safety of medicinal products before they are released to the market.

Drugs and medicinal ingredients are granted registration for circulation in Vietnam when they meet the following requirements:

• Ensuring safety and efficiency requirements;
• Manufactured at a facility that produces drugs and medicinal ingredients that meet the conditions prescribed by law;
• Manufactured according to the process of manufacturing drugs and medicinal ingredients and meeting quality standards, regulations and quality standards for drugs, medicinal ingredients, and packaging in direct contact with the medicine.

For imported drugs and medicinal ingredients when registering for circulation in Vietnam, establishments manufacturing drugs and medicinal ingredients abroad must be assessed for compliance with Good Manufacturing Practices in one of the following forms: following:

• Appraisal of documents related to production conditions;
• Recognition and mutual recognition of inspection and examination results of state pharmaceutical management agencies for requirements to meet Good Manufacturing Practices for drugs and medicinal ingredients;
• Inspection at establishments producing drugs and medicinal ingredients.

Pursuant to the content specified in Clause 4 and Clause 5, Article 54 of the Law on Pharmacy 2016.

Procedure for applying for a registration certificate for circulation of medicinal drugs

The process of applying for a medicinal drug circulation registration certificate for circulation of medicinal drugs includes many steps, from preparing documents to appraisal and licensing. This process requires strict compliance with regulations of the Ministry of Health.

Prepare registration documents

The first step in the process is to prepare the registration documents. Records need to be complete and accurate to avoid being returned or rejected.

Registration dossier includes the following documents:

1. Registration application according to Form 5/TT issued with this Circular;

>>> Download: Application for registration of medicinal ingredients

1. Power of attorney in the name of the registration facility (if any);
2. Authorization letter to sign on the registration dossier (if any);
3. Samples of drug labels, medicinal ingredients and drug use instructions expected to be circulated;
4. Certificate of eligibility for pharmaceutical business for Vietnamese registered establishments;
5. Legal documents, license to establish representative office in Vietnam for foreign registered establishments;
6. Legal documents of the facility manufacturing pharmaceutical ingredients, excipients, capsule shells, semi-finished pharmaceutical products, and medicinal materials;
7. Certificate of the testing facility for the cases specified in Clause 16, Article 22 of this Circular;
8. Samples of drug labels and drug use instructions actually circulated in the manufacturing country or CPP-issuing country for foreign drug registration dossiers;
9. CPP certificate for foreign drug registration dossiers;
10. Documents assessing compliance with GMP for the cases specified in Article 95 of Decree No. 54/2017/ND-CP for foreign manufacturers of drugs and medicinal ingredients when registering for circulation in Vietnam for foreign drug registration dossiers (except in cases where the establishment has published information to meet GMP on the website of the Drug Administration of Vietnam or the establishment has submitted a dossier to request assessment from the Drug Administration of Vietnam). meets GMP).
11. Compendium of medicinal herbs

Contents specified in Article 23, Article 28, 29, 30 of Circular No. 08/2022/TT-BYT dated September 5, 2022.

Licensing procedures

After completing the preparation, the enterprise will carry out procedures to apply for a registration certificate to circulate medicinal drugs according to the following steps:

Step 1: The establishment submits 01 set of application documents for circulation registration (registration documents) as prescribed in Section 3 (Articles 28, 29, 30 of Circular No. 08/2022/TT-BYT dated May 5/ September 2022 to the Department of Drug Administration – Ministry of Health (receiving agency).

Step 2: When receiving the registration dossier with all ingredients, meeting the requirements for form and full fees, the Drug Administration of Vietnam – Ministry of Health will issue the registration facility with a dossier receipt according to Form No. 09/TT issued. attached to Circular No. 08/2022/TT-BYT dated September 5, 2022 to the Department of Drug Administration – Ministry of Health (receiving agency).

Step 3: Within 12 months from the date of receiving complete documents, the Drug Administration of Vietnam – Ministry of Health is responsible for:

• Organize appraisal of registration dossiers;
• Submit to the Advisory Council for issuance of drug circulation registration certificates for registration dossiers requested to be granted, not issued or proposed to seek appraisal and advice from the Council.
• Granting drug circulation registration certificate according to the conclusion of the Appraisal Council, consulting on granting circulation registration certificate after approval from the Ministry’s leaders.

In case of applying the expedited appraisal process, the appraisal time will be shortened to 6 months.

Step 4:

In case the application does not meet the requirements, within the time limit for reviewing the registration application, the Department of Drug Administration – Ministry of Health must have a written response. The time for establishments to register amendments and supplements to documents is specified as follows:

• No more than 36 months in cases where pre-clinical, clinical, bioequivalence, and stability studies must be supplemented from the date of issuance of the document from the Drug Administration – Ministry of Health.
• No more than 12 months from the date of the document from the Department of Drug Administration – Ministry of Health for the remaining cases.

The time the facility registers to amend or supplement the dossier is not included in the dossier review time limit. If the above deadline is exceeded, the registration application is no longer valid and the establishment must re-implement the registration procedure.

In case of not granting registration for circulation of medicinal ingredients or not meeting the conditions for granting registration for circulation of medicinal ingredients, the Drug Administration of Vietnam – Ministry of Health must respond in writing and clearly state the reason. .

Step 5: Additional documents are submitted online, by mail or directly to the Drug Administration of Vietnam. The resolution process is carried out from Step 1. Within 6 months from the date of receipt of complete additional documents, the Drug Administration of Vietnam – Ministry of Health shall issue a Certificate of Circulation Registration or respond in writing clearly stating the reason. In case of applying the expedited appraisal process or shortened appraisal process, the time for processing additional documents is 03 months.

Fees for applying for a certificate of registration certificate for circulation of medicinal drugs

The cost of applying for a registration certificate for circulation of medicinal drugs includes many items, from application appraisal fees to testing and evaluation costs. These fees are specifically regulated by the Ministry of Health and the Ministry of Finance.

Document appraisal fee is the main cost of 11,000,000 VND

Consulting and supporting applications for registration certificate for circulation of medicinal drugs

Consulting services to support applications for a registration certificate for circulation of medicinal drugs provide professional support for businesses in the process of implementing this complex procedure. Experts in the pharmaceutical and legal fields will accompany businesses from preparing documents until receiving licenses.

Consulting and support services for applying for registration certificate for circulation of medicinal drugs at Long Phan include:

• Preliminary assessment of the product’s ability to meet licensing conditions
• Instructions for preparing complete and accurate registration documents
• Review and complete technical documents
• Business representatives work with management agencies
• Monitor application processing progress and promptly respond to additional requests

Using consulting services helps businesses save time, minimize the risk of application rejection and increase their chances of being quickly licensed. Especially for businesses applying for registration for the first time, expert support is extremely important.

If you need support with procedures for applying for a registration certificate for circulation of medicinal drugs, please contact us via hotline 0906735386. Long Phan’s team of experts will provide detailed advice and support customers throughout the process. process from preparing documents to receiving the license. We are committed to providing optimal solutions, helping your business save time, costs and ensure full compliance with current legal regulations.