1. What is the definition of medicine in Vietnam?
According to the Law on Pharmaceuticals No. 105/2016/QH13, medicine is a product containing active ingredients or medicinal herbs used for humans to prevent, diagnose, treat, alleviate, and adjust the physiological functions of the human body. This includes pharmaceutical drugs, herbal medicines, traditional medicines, vaccines, and biological products.
Given the importance of medicine, the Vietnamese government has implemented strict regulations for each type of medicine to ensure effective management and use.
Before circulating medicine on the market, manufacturers and importers must register the medicine with the Ministry of Health.
2. Regulations on Drug Circulation Registration
Regulations are specified in detail in the following documents:
- Circular 32/2018/TT-BYT on drug and pharmaceutical ingredient circulation registration.
- Circular 29/2020/TT-BYT amending, supplementing, and repealing some legal documents issued by the Minister of Health and jointly issued.
- Circular 01/2020/TT-BYT on labeling and instructions for use.
Drugs manufactured and circulated in Vietnam for disease prevention, treatment, and health improvement must be registered and granted a registration number by the Ministry of Health. In special cases (drugs for epidemic prevention, natural disasters, or drugs in shortage), the Ministry of Health will consider circulating drugs without a registration number.
3. Introducing Drug Circulation Registration Service
Drug circulation registration procedures are the process of REQUESTING PERMISSION to circulate products that are drugs (medicines, vaccines, biological products) under the management of the Ministry of Health.
Thien Di's fast drug circulation registration procedure:
Not only in Vietnam but also in other countries around the world, drug circulation registration is one of the most time-consuming tasks, requiring the person performing it to have a good grasp of the process, specialized knowledge, and good experience. Those who perform drug circulation registration must also regularly study and update the regulations and requirements of the management agency to apply them flexibly and effectively.
The state management agency for registration number granting is the Department of Drug Administration, Ministry of Health.
Services:
The drug circulation registration service at Thien Di will help customers perform the entire or a part of the drug registration process in a simple, effective, and most cost-saving way.
Professional staff and consultants will support customers with the maximum possible documents and procedures to shorten the preparation time.
Customers will be ensured to submit to the Department of Drug Administration as soon as possible and be closely monitored to minimize the complications that slow down the process of granting a visa for the product.
4. Subject and Requirements for Drug Registration in Vietnam
Subject to Drug Registration
All drugs must be registered before being circulated in Vietnam, except for the following cases:
- Drugs compounded according to prescriptions at pharmacies as specified in Point b, Clause 1, Article 47 of the Law on Pharmaceuticals.
- Drugs manufactured or compounded at medical examination and treatment facilities as specified in Article 85 of the Law on Pharmaceuticals.
- Imported drugs as specified in Clause 2, Article 60 of the Law on Pharmaceuticals 2016.
- Traditional medicines as specified in Clauses 1 and 2, Article 70 of the Law on Pharmaceuticals 2016.
Entities Eligible to Register Drugs and Pharmaceutical Ingredients
The following entities are eligible to register drugs and pharmaceutical ingredients:
- Entities engaged in the production, wholesale, export, and import of drugs and pharmaceutical ingredients in Vietnam.
- Foreign entities trading in drugs and pharmaceutical ingredients that have representative offices in Vietnam, in accordance with regulations.
Requirements for Drug Registration
To obtain a drug registration certificate in Vietnam, drugs and pharmaceutical ingredients must meet the following requirements:
- Ensure safety and efficacy.
- Be manufactured at a drug and pharmaceutical ingredient manufacturing facility that meets the conditions specified in the Law on Pharmaceuticals 2016.
- Be manufactured following the drug and pharmaceutical ingredient manufacturing process and meet the quality standards specified in Articles 102 and 103 of the Law on Pharmaceuticals 2016.
Requirements for Imported Drugs and Pharmaceutical Ingredients
For imported drugs and pharmaceutical ingredients registered in Vietnam, the overseas drug and pharmaceutical ingredient manufacturing facility must be evaluated for compliance with Good Manufacturing Practices (GMP) in one of the following ways:
- Dossier assessment related to manufacturing conditions.
- Mutual recognition of inspection and testing results by the state drug regulatory authority for the requirements of compliance with GMP for drugs and pharmaceutical ingredients.
- On-site inspection of the drug and pharmaceutical ingredient manufacturing facility.
The Government shall specify in detail the registration procedures for medicinal herbs, excipients, and capsules.
5. Drug Registration License Application Process
Step 1: Prepare 1 original set + 2 copies (including Application Form + Quality Standard and Finished Product Testing Method) + 2 original sets (Expected Label and Instructions for Use).
Step 2: Upload online to the Ministry of Health's Drug Administration Department's online public service portal following the instructions in Circular No. 03/QLD-ĐK dated January 2, 2020.
Step 3: Submit the application in person (according to the schedule on the public service portal) or send it by mail to the Drug Administration Department – Ministry of Health.
Step 4: The Drug Administration Department receives, reviews the application, organizes a drug review council, and issues a list of drugs granted registration numbers.
Step 5: Notify the unit or issue a decision to issue a registration number at the receiving location.
Administrative Procedure Agency: Drug Administration Department – Ministry of Health.
Processing Time: Within 06 months from the date of receiving a complete and valid application.
State Fee: Initial application review fee according to state regulations: VND 15,500,000.
6. Guidelines for Drug Registration Procedures
6.1. Drug Registration Procedures for Domestically Produced Chemical Drugs
Drug registration dossiers include:
- Cover page (Form 1/TT)
- Table of contents (Form 5/TT)
- Product information sheet (Form 4A/TT)
- Initial registration application (Form 6A/TT)
- Sample label and package insert of the drug intended for circulation
- Origin of the formula and reference materials for the package insert
- Certificate of Good Manufacturing Practice (GMP) of the drug manufacturing facility
- Legal documents for active ingredients, excipients, and capsules (required for active ingredients)
- Legal documents of the packaging manufacturing facility
- Quality dossier: according to ACTD
*Note:
- GMP/CPP legalized by consular, certification and/or online verification link at the issuing agency (in English)
- Certificate of analysis of active ingredients, excipients, and finished products (from both the raw material manufacturer and the drug manufacturer)
- For all raw material or finished product control parameters performed according to the manufacturer's standard, it is necessary to provide analytical procedure validation documentation.
- The stability of the active ingredient must be signed and stamped by the manufacturer.
Search for trademarks or certificates of trademark protection for drugs with trade names (certified copy) (if any)
Names of forms and declarations (Attached to this procedure)
- Cover page
- Table of contents
- Initial registration application
- Product information sheet
- Sample label and package insert of the drug.
6.2. Registration Procedures for Foreign Pharmaceutical Products Circulating in Vietnam
CONDITIONS FOR REGISTERING ENTITIES:
- Must have a Certificate of Good Pharmaceutical Business Practice (GMP) or a Representative Office in Vietnam.
DOSSIER FOR REGISTERING FOREIGN NEW DRUGS CIRCULATING IN VIETNAM INCLUDES:
- Cover page (Form 1/TT)
- Table of contents (Form 5/TT)
- Product information sheet (Form 4A/TT)
- Initial registration application (Form 6A/TT)
- Sample label and instructions for use of the medicine intended for circulation
- Origin of the formula and reference materials for the instructions for use
- Marketing authorization for the drug in the manufacturing country issued by the competent authority (FSC or CPP).
- Power of Attorney (Form 8/TT)
- Sample label and instructions for use of the medicine actually circulated in the manufacturing country or the country granting CPP
- Documents assessing GMP compliance for cases specified in Article 95 of Decree No. 54/2017/ND-CP for foreign drug manufacturing establishments when registering for circulation in Vietnam.
- Legal documents for active ingredients, excipients, capsules (required for active ingredients)
- Legal documents of the product packaging facility
- Quality dossier: according to ACTD
*Notes:
- GMP/CPP consular legalization, certification and/or online verification link at the issuing authority (in English)
- Test certificates for active ingredients, excipients, finished products (from both the raw material manufacturer and the drug manufacturer)
- For all raw material or finished product control indicators performed according to the manufacturer's standards, it is necessary to provide analytical procedure validation documents.
- Stability of the active ingredient requires a signed and stamped copy from the manufacturer.
Search for a trademark or certificate of trademark protection for medicines with a trade name (certified copy) (if any)
All documents in the dossier must be signed and confirmed by the manufacturing establishment (signed and stamped). The dossier for registration of circulation of foreign drugs must be written in Vietnamese or English. The instructions for use of the medicine must be written in Vietnamese.
Names of application forms and declaration forms (Attached to this procedure).
Cover page:
- Table of contents:
- Initial registration application.
- Product information
- Sample label and instructions for use of the medicine.
7. Validity of Drug Registration Number in Vietnam
Article 8. Validity, Symbols of Drug and Drug Ingredient Circulation Registration Certificate and Deadline for Submitting Renewal Application
1. The validity of the drug and drug ingredient circulation registration certificate is 05 years from the date of issuance or renewal, except for the case specified in Clause 2 of this Article.
2. The validity of the circulation registration certificate is 03 years from the date of issuance for the following drugs:
a) New drugs, vaccines first granted a circulation registration certificate, reference biologicals, biosimilars first granted a circulation registration certificate in Vietnam;
b) Drugs with the same active ingredient, concentration, content, dosage form as new drugs that have not been granted a 5-year circulation registration certificate;
c) Drugs not falling into the cases specified in points a and b of this Clause, but at the time of submitting the application for renewal of the circulation registration certificate, there is no safety and efficacy report for the reason of not yet being circulated or there is a safety and efficacy report but the number of drugs used, the number of patients, and the duration of use are still limited according to the opinion of the Advisory Council for Granting Drug and Drug Ingredient Circulation Registration Certificates or there is a recommendation from the medical facility on the need to continue monitoring safety and efficacy.
d) Cases of continued monitoring of safety and efficacy according to the advisory opinion of the Advisory Council for Granting Drug and Drug Ingredient Circulation Registration Certificates.
3. Within 12 months before the expiry of the circulation registration certificate, the registered entity may submit an application for renewal of the circulation registration certificate. After the expiry date of the circulation registration certificate, the entity shall submit the application in the form of a new circulation registration certificate.
4. Each drug and drug ingredient circulation registration certificate has a separate code to distinguish: domestically produced, imported drugs, drug ingredients, vaccines, biologicals, technology transferred drugs, drugs secondarily packaged in Vietnam.
5. Within the validity period of the old circulation registration certificate, if the registered entity is granted a new drug circulation registration certificate, the validity of the old circulation registration certificate will continue to be valid at the same time as the new circulation registration certificate within 06 months from the date of the new circulation registration certificate taking effect.
In summary:
- Drug registration numbers are used to distinguish different drugs on the market.
- The validity of a drug and drug ingredient circulation registration certificate is 05 years from the date of issuance or renewal.
- The validity of a circulation registration certificate is 03 years from the date of issuance for certain drugs as specified above.
- Within 12 months before the expiry of the circulation registration certificate, the registered entity may submit an application for renewal of the drug circulation registration certificate.
- Each drug and drug ingredient circulation registration certificate has a separate code to distinguish it from others.
- Within the validity period of the old circulation registration certificate, if the registered entity is granted a new drug circulation registration certificate, the validity of the old circulation registration certificate will continue to be valid at the same time as the new circulation registration certificate for 06 months according to the law.
8. Procedures for Renewing, Amending, and Supplementing Drug Registration Certificates
8.1. Renewal Procedures for Chemical Drugs
- Application form according to Form 6B/TT issued with this Circular.
- Power of attorney (if any) according to Form 8/TT issued with this Circular.
- Certificate of Good Pharmaceutical Manufacturing Practices (GMP) for Vietnamese registered entities.
- Legal documents for foreign registered entities.
- License for establishing a representative office in Vietnam for foreign registered entities.
- Certificate of Pharmaceutical Product Certificate (CPP) according to Form 7/TT issued with this Circular.
- Report on drug safety, efficacy, and usage according to Form 2/TT issued with this Circular.
- Report on drug and pharmaceutical ingredient circulation according to Form 11/TT issued with this Circular.
- Certificates, protection certificates, contracts for transferring ownership of industrial property rights, documents certifying the origin of raw materials (GACP, CEP, domestic medicinal herbs, imported medicinal herbs, ...) and related documents (if any).
- A copy of the drug registration certificate in Vietnam.
FOR TRADITIONAL MEDICINES
The dossier for renewing the drug registration certificate for traditional medicines includes:
1. Application for renewal of registration certificate
2. Legal documents in case the entity registering the traditional medicine is a manufacturing entity:
a) A copy of the Certificate of Good Pharmaceutical Manufacturing Practices (GMP) for traditional medicine manufacturing in Vietnam;
b) CPP of imported traditional medicines for foreign traditional medicine manufacturers, except for traditional medicinal herbs. If the CPP does not confirm that the manufacturing facility meets GMP standards, an additional GMP certificate from the foreign traditional medicine manufacturing facility must be submitted. If there are multiple entities involved in the manufacturing process of the drug, GMP certificates must be submitted from all participating manufacturing entities.
3. Legal documents in case the entity registering the traditional medicine is not a traditional medicine manufacturing entity:
a) Legal documents according to points a and b above;
b) Legal documents of the entity registering the circulation of traditional medicines:
A copy of the Certificate of Good Pharmaceutical Manufacturing Practices (GMP) for domestic entities with one of the following business scopes: manufacturing, wholesaling, exporting, importing traditional medicines;
A license to establish a representative office in Vietnam and a manufacturing and trading license for drugs issued by the competent state management agency of the foreign country according to regulations for foreign traditional medicine manufacturing entities with a representative office in Vietnam.
And the documents specified in Clause 6 and Clause 7 of Article 16 of this Circular for the case of traditional medicines with changes in the administrative dossier at the time of registration for renewal.
4. Report on the circulation of traditional medicines
5. Report on safety and efficacy for drugs required to continue monitoring safety and efficacy.
6. A copy of the drug registration certificate granted in Vietnam.
FOR MEDICINAL HERBS
1. Three months before the expiry date of the drug registration certificate, the registered entity shall submit one set of the dossier for renewing the drug registration certificate for medicinal herbs (renewal dossier) to the Department of Traditional Medicine Management, Ministry of Health (the receiving agency) in person or online via the public service portal.
2. Upon receiving a complete renewal dossier that meets the requirements on form, the receiving agency shall issue a Receipt of Dossier to the registered entity. If the dossier is incomplete, the receiving agency shall issue a written notice or request the registered entity to supplement the dossier as prescribed.
3. Within three months from the date of receiving a complete dossier, the receiving agency shall consider and approve the list of medicinal herbs for which the drug registration certificate is renewed.
4. If the dossier does not meet the requirements, within the time limit for reviewing the registration dossier, the receiving agency must promptly issue a written instruction to the registered entity to amend and supplement the dossier until it meets the requirements. The time for the registered entity to amend and supplement the dossier shall not exceed 60 days from the date of the receiving agency's written notice. The time for the registered entity to amend and supplement the dossier shall not be counted in the time limit for reviewing the dossier. If the deadline of 60 days is exceeded, the renewal application will be invalid and the entity must re-apply for renewal.
5. In case of non-renewal, the receiving agency shall reply in writing and state the reason.
8.2. Changing/Supplementing Information in a Drug Circulation Registration Certificate While it is Still Valid
Procedure:
Step 1: Submit the application for change/supplementation to the Drug Administration Department - Ministry of Health (the receiving agency).
Step 2: Upon receiving a complete application with the correct format and sufficient fees, the Drug Administration Department - Ministry of Health will issue a Receipt of Application Form No. 12/TT to the applicant, according to Circular No. 32/2018/TT-BYT dated November 12, 2018.
Step 3: The Drug Administration Department reviews the application.
Step 4: The Department sends a notification or an approval letter for the change/supplementation to the applicant at the receiving location.
Administrative agency: The Drug Administration Department - Ministry of Health.
Processing time: Within 6 months from the date of receiving a complete and valid application.
State fees: Application review fee according to state regulations: VND 1,500,000.
Implementation method:
Submit directly or by mail to the Drug Administration Department, Ministry of Health.
Application components:
The application for changing/supplementing a drug circulation registration certificate includes:
1. Application Form No. 6C/TT issued with Circular No. 32/2018/TT-BYT.
2. Documents corresponding to the minor change contents specified in Appendix II issued with this Circular. For vaccines of the same product owner or the same manufacturing facility or the owner of a drug circulation registration certificate accepting to change the manufacturing facility location in the same country or abroad that has been granted a circulation registration certificate.
Number of application sets: 01 main set (note: submit 2 additional sets of the proposed change label and instructions for use)
Processing time:
Within 15 working days from the date on the application receipt, the Drug Administration Department - Ministry of Health is responsible for:
a) Organizing the review of the application;
b) For the changes of MiV-N1, MiV-N2, MiV-N3, MiV- N4, MiV-N6, MiV-N7 specified in Appendix II issued with Circular No. 32/2018/TT-BYT: The Drug Administration Department publishes on the website of the Drug Administration Department the minor changes that only require notification submitted by the facility.
c) For minor changes that only require notification other than those specified in Appendix II issued with Circular No. 32/2018/TT-BYT: Approve the change request of the facility; Publish on the website of the Drug Administration Department the minor changes that only require notification submitted by the facility and the results of the application.
Step 4:
- If the application does not meet the requirements, within the application review period, the Drug Administration Department - Ministry of Health must promptly issue a written instruction to the applicant for specific amendments and supplements to the application until it meets the requirements.
- The facility must supplement the application within 12 months from the date of the written document of the Drug Administration Department - Ministry of Health. The time for the applicant to amend and supplement the application is not counted in the application review period. If the deadline is exceeded, the application will be invalid and the facility must re-apply.
- In case of non-acceptance of the change, the Drug Administration Department - Ministry of Health must respond in writing and state the reasons clearly.
Subject:
Drug and pharmaceutical ingredient registration facilities
Administrative agency:
The Drug Administration Department - Ministry of Health
Result of administrative procedure:
Drug circulation registration certificate
10. Things to Consider When Registering for Drug Circulation in Vietnam
In addition to the issues of documentation, procedures, and management agencies, there are a few other things to keep in mind:
- Double-check the information: After receiving the drug circulation registration certificate, carefully review it to ensure that it matches the submitted dossier. If there are any discrepancies, immediately initiate the correction procedure.
- Maintain the certificate's validity: The validity of a drug circulation registration certificate is 3 or 5 years from the date of issuance, renewal, or extension. During the certificate's validity period, it is necessary to update the quality standards of finished products, active ingredients, and excipients according to Circular 11/2018/TT-BYT dated May 4, 2018, and the drug instruction leaflet according to Circular 01/2018 dated January 18, 2018.
- Ensure the remaining shelf life for imported drugs: The remaining shelf life of imported pharmaceutical drugs at the time of customs clearance must be at least 18 months for drugs with a shelf life of over 24 months, and half of the shelf life for drugs with a shelf life of 24 months or less.
11. Searching for Drug Circulation Registration Certificates
12. Thien Di's Drug Circulation Registration Service
12.1. Values of Thien Di's Service
Contact us immediately for a completely free consultation! With a team of experienced legal experts in the field, registering drug circulation for your products will be easier than ever when we consult and support you. You only need to provide information about your business, product samples, and other related documents. You will be:
- Consulted and answered all your questions.
- Provided with ingredient evaluation and verification.
- Supported with testing at state-designated centers.
- Assisted in preparing the registration dossier.
- Assisted in submitting the dossier and monitoring the results.
- Provided with the results and delivered to you.
- Consulted on post-drug circulation registration issues.
12.2. In addition, you can refer to some other services of Thien Di such as:
- Trademark registration
- Trademark registration procedures
- Exclusive product registration
- Product exclusivity registration
- Intellectual property registration of trademarks
- Trademark and logo registration
- Trademark registration at the Intellectual Property Office
- Trademark registration at the Intellectual Property Office
- Food trademark registration
- Cosmetic registration
- Industrial design registration
- Copyright registration
- Service of applying for import license of medical equipment
- Import license for medical equipment and devices
- Procedures for importing medical equipment and devices
- Applying for import license of medical equipment
- ...
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
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