Decision No. 3121/2001/QD-BYT on the Drug Registration Regulation

Pursuant to …;

Regulations on Drug Registration

_______________

 

THE MINISTER OF HEALTH

Based on the Law on People's Health Protection dated July 11, 1989 and the Pharmaceutical Drug Regulation for Disease Prevention and Treatment issued together with Decree No. 23/HĐBT, January 24, 1991 of the Council of Ministers (now the Government);

Based on Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Vietnam National Medicines Administration;

Pursuant to …;

Article 1. Now hereby promulgating with this Decision the "Regulations on Drug Registration"

Article 2. This Decision shall take effect fifteen days from the date of issuance and shall replace Decision No. 1203/BYT-QĐ dated July 11, 1996 promulgating the Regulations on Drug Registration. All previous regulations that conflict with those set forth in these Regulations are hereby abolished.

Article 3. The Heads of the Office, Inspectorate, and relevant Departments of the Ministry of Health, the Director of the Vietnam National Medicines Administration, the Heads of subordinate units under the Ministry, Directors of Provincial Health Departments, Central City Health Departments, Sectoral Health Services, and Directors of drug manufacturing and registration enterprises are responsible for implementing this Decision.

 

REGULATIONS

DRUG REGISTRATION
(Issued together with Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 of the Minister of Health)

To unify state management over drug production and circulation, to ensure the safety, efficacy, and quality of drugs, the Ministry of Health promulgates the Regulations on Drug Registration for disease prevention, treatment, and health enhancement (referred to as the Regulations on Drug Registration).

Drugs produced and circulated in Vietnam for disease prevention, treatment, and health enhancement must be registered and obtain a registration number from the Ministry of Health. In special cases (drugs for epidemic control, disaster relief, or scarce drugs), the Ministry of Health may allow circulation of drugs without a registration number.

Chapter 1

GENERAL PROVISIONS

Article 1. 2.1. Scope of Application.

Article 2. Scope of Application

- Drugs produced by legitimate establishments both domestically and internationally that meet the required conditions must be registered.

- New drugs developed successfully by scientific research institutions, while awaiting technology transfer to qualified production establishments, may be registered for production at their own establishment if they meet the necessary conditions.

- Licensed production of branded drugs can only occur at domestic production facilities within Vietnam that meet Good Manufacturing Practice (GMP) standards.

- Drugs produced by healthcare establishments for in-house patient care or specialized clinics (these drugs cannot be sold on the market) must comply with formulas, production processes, quality standards, safety, and efficacy requirements established by the facility director.

2.2. Applicability.

The following entities are permitted to register drugs for production and circulation in Vietnam.

- Domestic drug manufacturing facilities

- Domestic entities engaged in pharmaceutical trade, and foreign entities already granted permission by the Ministry of Health to operate in the pharmaceutical sector in Vietnam.

Within these Regulations, certain terms are defined as follows:

Article 3. 3.1. Drugs are products intended for human use to prevent, treat, alleviate symptoms, diagnose diseases, or adjust physiological functions.

3.2. Finished drugs are forms of drugs that have completed all stages of production for distribution and use.

3.3. Drug raw materials include active ingredients (active substances) or inactive ingredients (solvents, excipients) that form part of the product during the manufacturing process.

3.4. Modern drugs include:

- Chemical and biological raw materials used in drug production.

- Finished chemical and biological products.

3.5. Traditional herbal medicines: medicines prepared according to ancient medical texts, specifying the number of herbs, quantities, preparation methods, dosages, usage instructions, and indications.

3.6. New drugs are those with new formulations containing new active substances, new combinations of active substances, or new dosage forms, indications, or routes of administration.

3.7. Brand name is a name given to a drug by its manufacturer that differs from its generic name or common international name.

3.8. Drug stability refers to the ability of a drug (raw material or finished product) stored under specified conditions to maintain its inherent physical, chemical, microbiological, pharmacological, and toxicological characteristics within prescribed limits.

3.9. Shelf life of a drug is the period from production until it retains the quality criteria specified in the quality standard under defined storage conditions.

3.10. Expiry date of a drug is the period determined from the completion of drug production during which, when stored under specified conditions, the drug must meet the quality standards registered, beyond which it may not be circulated or used.

3.11. Branded drug production: drugs produced by a domestic or foreign establishment that has been granted a registration number for circulation (in Vietnam or abroad) and transferred the right to produce the drug to another domestic establishment with production capabilities.

The drug registration dossier must consist of three copies, one of which is the original. If original documents are unavailable, certified copies must be provided:

Article 4. - Drug Circulation Permit (FSC).

- Certificate of Compliance with Good Manufacturing Practice (GMP).

(FSC and GMP certificates may be replaced by Product Certification (CPP) certificates).

Additionally, two sets of drug labels must accompany the registration dossier. The dossier must be clearly printed on A4 paper, arranged in the prescribed sequence, and sections must be separated.

All documents in the dossier must be confirmed by the producing entity (signed and stamped). If drug label samples in the dossier are affixed to A4 paper, they must be stamped across the label.

- Drug registration dossiers submitted by domestic drug manufacturers must be in Vietnamese.

- Foreign drug registration dossiers must be in Vietnamese or English. The summary of drug characteristics must be in Vietnamese.

- The pharmaceutical product registration dossier for foreign drugs must be written in Vietnamese or English. The summary sheet of drug characteristics must be written in Vietnamese.

The names of drug components in the dossier must be the original name or the commonly used generic name both domestically and internationally. For medicinal materials, the scientific name in Latin must also be recorded alongside the medicinal material name.

- For domestically produced drugs with a brand name, the drug registration dossier must include a copy of the non-similar search result or trademark protection certificate issued by the National Office of Intellectual Property. Upon request, a comprehensive trademark search or industrial design search at the National Office of Intellectual Property (Ministry of Science and Technology and Environment) shall be conducted.

For foreign drugs that have been permitted to circulate in their home country, upon request, a trademark and design search at the National Office of Intellectual Property shall be carried out.

- Domestic entities registering for the first time to produce drugs must have.

+ A business registration certificate clearly stating the functions.

+ A certificate confirming that the production facility meets Good Manufacturing Practice (GMP) standards or a certificate confirming compliance with production standards and conditions issued by the competent authority (applicable only to drugs from medicinal materials).

Article 5. Requirements for drug labels:

The information on the drug label must comply with the Circular guiding the labeling of drugs currently in force by the Ministry of Health and the Labeling Regulations promulgated by Decision No. 178/1999/TTg dated August 30, 1999 of the Prime Minister.

The brand name and overall trademark of the drug (words, images, or combinations thereof expressed in one or more colors) must not be identical or similar enough to cause confusion with the name or overall trademark of another entity's drug already registered by the Ministry of Health, must not infringe intellectual property rights, and must not mislead about the nature of the drug or its capabilities. The Ministry of Health encourages entities to name drugs using the original name or commonly used generic name both domestically and internationally.

Information such as barcodes, serial numbers, medals, awards, and industrial property symbols intended to be included on the label must be accompanied by a copy of the relevant legal document.

Drug labels circulating in the market must match the color and design of the drug label in the registration dossier.

Article 6. Drugs that have been granted a registration number, within the validity period of the registration number, if any of the following contents need to be changed, a new registration dossier must be submitted:

- Changing the drug components or formula.

- Changing the drug dosage form.

- Changing the drug quality standards or testing methods.

- Changing the route of administration.

- Changing the production method or process.

- Changing the production facility.

Article 7. Drugs that have been granted a registration number, within the validity period of the registration number, if any of the following contents need to be changed or supplemented, permission from the Ministry of Health must be obtained:

- Changing the drug name.

- Changing the dosage.

- Changing the registration entity.

- Changing the production facility name (the location of the production facility does not change).

- Changing the drug appearance or color without affecting the quality standards or testing methods.

- Changing or supplementing the drug indications.

- Changing or supplementing the drug contraindications.

- Changing the production location (the production facility does not change).

- Changing the drug expiration date.

- Changing the label format.

- Changing or supplementing the packaging specifications.

When changing or supplementing any of the items under Article 7, the dossier includes:

- Form 1-ĐKT, 9A-ĐKT (domestic drugs) or 9B-ĐKT (foreign drugs), 9C-ĐKT when changing the registration entity (one original copy).

- Relevant documentation regarding the requested changes or supplements (one original copy).

For foreign drugs: When changing the drug name, a permit for circulation of the newly named drug in the country where the drug is produced (FSC) must be provided.

When changing the production facility location, a certificate confirming that the new production facility meets Good Manufacturing Practice (GMP) standards must be provided. When changing the production facility name, a certificate confirming that the new production facility meets GMP standards must be provided. (The FSC and GMP certificates are issued by the competent authority in the home country).

Article 8.

- The registration number is valid for five years from the date of issuance. In special cases, the Ministry of Health will consider and make specific regulations. The registration number must be printed on the drug label.

- Entities wishing to re-register to continue producing and circulating drugs in Vietnam must submit the dossier six months before the registration number expires. If the dossier is not submitted within six months after the registration number expires, a new registration dossier must be prepared if they wish to continue registering.

- The re-registration dossier is stipulated in Article 15 of Chapter II (for domestically produced drugs), Article 19 of Chapter III (for foreign drugs), and Article 22 of Chapter IV (for licensed-produced drugs) of this Regulation.

Article 9. Provisions on stability research and drug expiration date registration.

9.1. Drug stability.

All drugs after production must be stored according to the conditions specified by the manufacturer based on drug stability studies.

- The stability research dossier must detail: storage conditions of the drug samples (temperature, humidity...), packaging, research methods, results of at least three different batches of drugs, conclusions on drug stability.

- The results of drug stability research using accelerated aging methods are only valid for predicting the shelf life when applying for the initial registration number. For licensed-produced drugs: if there is no stability research data for drugs produced in Vietnam, stability research data under normal conditions provided by the licensing entity can be used. During circulation, the manufacturer must monitor the stability of the drug under normal conditions to confirm its stability. When re-registering, stability research data under normal conditions must be provided.

- Foreign drugs that have circulated for a period equal to or longer than their expiration date must provide stability research data under normal conditions when applying for circulation in Vietnam.

9.2. Drug expiration date.

- The expiration date of the drug must be established based on drug stability research. The drug expiration date cannot exceed the shelf life determined by the research.

The director of the facility shall be responsible for the quality of the drugs produced and circulated on the market within the registered shelf life period.

Article 10.

Domestic drug registration facilities must submit drug registration applications to the specialized state management agencies (Department of Health, Health Sector) to confirm legal entity status, production conditions, and the Ministry of Health's opinion on issuing registration numbers (except for types of drugs listed in Appendix 1). Within the latest seven days from receiving valid applications, the specialized state management agency must confirm the application of the unit. Subsequently, the dossier is transferred by the registration facility to the Ministry of Health for review and issuance of registration numbers. For drug registration applications of units that are members of the National Pharmaceutical Corporation or wholly foreign-owned enterprises, only the signature and seal of the facility director are required, and the drug registration dossier is submitted to the Ministry of Health (except for drugs listed in Appendix 1).

The Ministry of Health will respond with results no later than three months for domestically produced drugs and twelve months for imported drugs, calculated from the date of receipt of complete and valid dossiers.

For drugs listed in Appendix 1, the registration dossiers are submitted to the local Department of Health where the production facility is located for review. After the drugs pass the review requirements, the local Department of Health compiles a list (clearly stating the name of the drug and active ingredients) along with a letter sent to the Ministry of Health to issue a decision granting registration numbers.

Facilities must be responsible for sending drug quality standards to the Institute of Testing, Branch Institutes of Testing, provincial and municipal testing centers after the drugs have been granted registration numbers.

Article 11. Drug registration facilities must pay registration fees according to current regulations.

Chapter 2

Dossier for Registration of Drugs Produced Domestically

Article 12.

12.1. The raw material drug registration dossier includes:

Cover page (Model 1-DR)

Table of contents of the dossier (Model 2-DR)

Application form (Model 3A-DR)

Production process (fully detailed)

Quality standards and testing methods (fully detailed)

Drug testing report from one of the following institutions: Institute of Testing, Branch Institutes of Testing, production facility meeting Good Manufacturing Practice (GMP) standards, laboratory meeting Good Laboratory Practice (GLP) standards for testing at the production facility.

- Research materials on the stability of raw materials.

- Drug label (designed or attached to Model 7-DR).

- Raw material sample: one package (sufficient quantity for three tests).

12.2. For new raw material drug registration dossiers, in addition to the provisions under Clause 12.1 of Article 12, additional materials must be supplemented:

- Toxicity research materials.

- Preclinical pharmacology research materials.

- Clinical pharmacology research materials.

Article 13.

13.1. The new chemical drug registration dossier includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2 DR).

- Application form (Model 4A-DR).

- Summary of drug characteristics (Model 6-DR)

- Production process (fully detailed)

- Quality standards and testing methods (fully detailed)

- Drug testing report from one of the following institutions: Institute of Testing, Branch Institutes of Testing, production facility meeting Good Manufacturing Practice (GMP) standards, laboratory meeting Good Laboratory Practice (GLP) standards for testing at the production facility.

- Research materials on the stability of the drug.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

13.2. For new chemical drug registration dossiers, in addition to the provisions under Clause 13.1 of Article 13, additional materials must be supplemented:

- Toxicity research materials (acute toxicity, subchronic toxicity, chronic toxicity, cellular toxicity...).

- Preclinical pharmacology research materials.

- Pharmacokinetics and bioavailability research materials.

- Clinical pharmacology research materials.

- Acceptance certificate of the Ministry-level Scientific Council.

Article 14.

14.1. The registration dossier for drugs containing herbal components, traditional prescriptions, and components from herbs already in use with known indications, which have been granted registration numbers by the Ministry of Health for production and circulation, includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Model 4A-DR).

- Summary of drug characteristics (Model 6-DR)

- Production process (fully detailed)

- Quality standards and testing methods (fully detailed)

- Drug testing report from one of the following institutions: Institute of Testing, Branch Institutes of Testing, provincial and municipal drug testing centers, production facility meeting Good Manufacturing Practice (GMP) standards, laboratory meeting Good Laboratory Practice (GLP) standards for testing at the production facility.

- Research materials on the stability of the drug.

- Origin documentation of the formula.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

14.2. For registration dossiers of drugs containing herbal components that are not traditional prescriptions, but have different indications, in addition to the provisions under Clause 14.1 of Article 14, additional materials must be supplemented:

- Clinical trial materials evaluating the safety and efficacy of the drug from herbs (conducted according to current regulations of the Ministry of Health).

- Acceptance certificate of the Ministry-level or facility-level Scientific Council for drugs from specialized research institutes under the Ministry.

Article 15. Resubmission dossier for domestically produced drugs includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Model 5A-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug label (designed or attached to Model 7-DR).

- Report on the circulation process of the drug (Model 8-DR).

- Drug sample: one packaged unit for each registered format.

Chapter 3

Dossier for Registration of Imported Drugs

Article 16.

16.1. The raw material drug registration dossier includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Model 3B-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug marketing authorization from the competent authority in the country of manufacture (FSC).

- Certificate of Good Manufacturing Practice (GMP) issued by the competent authority for the production facility.

- Production process (fully detailed)

- Quality standards and testing methods (fully detailed)

- Drug testing report from the production facility.

- Research materials on the stability of raw materials.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one package (sufficient quantity for three tests).

16.2. For new raw material drug registration dossiers, in addition to the provisions under Clause 16.1 of Article 16, additional materials must be supplemented:

- Toxicity research materials.

- Preclinical pharmacology research materials.

- Clinical pharmacology research materials.

Article 17.

17.1. The new chemical drug registration dossier includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Model 4B-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug marketing authorization from the competent authority in the country of manufacture (FSC).

- Certificate of Good Manufacturing Practice (GMP) issued by the competent authority for the production facility.

- Production process (fully detailed)

- Quality standards and testing methods (fully detailed)

- Drug testing report from the production facility.

- Research materials on the stability of the drug.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

17.2. For new chemical drug registration dossiers, in addition to the provisions under Clause 17.1 of Article 17, additional materials must be supplemented:

- Toxicity research materials (acute toxicity, subchronic toxicity, chronic toxicity, cellular toxicity).

- Preclinical pharmacology research materials.

- Pharmacokinetics and bioavailability research materials.

- Clinical pharmacology research materials.

Article 18.

18.1. The registration dossier for drugs containing herbal components already in use and with known indications in Vietnam includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Model 4B-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug marketing authorization from the competent authority in the country of manufacture (FSC).

- Certificate of Good Manufacturing Practice (GMP) issued by the competent authority for the production facility.

- Production process (fully detailed)

- Quality standards and testing methods (fully detailed)

- Drug testing report from the production facility.

- Research materials on the stability of the drug.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

18.2. In addition to the provisions set out in Clause 18.1 of Article 18, for drug registration files containing components from medicinal herbs that have been used in Vietnam but with different indications, or from medicinal herbs not previously used in Vietnam, the following must be supplemented:

- Clinical trial data evaluating the safety and efficacy of the herbal drug (as per current regulations of the country of origin or the World Health Organization - WHO).

Article 19. The re-registration file for foreign drugs includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Form No. 5B-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug label (designed or affixed on Form No. 7-DR).

- Drug marketing authorization from the competent authority in the country of manufacture (FSC).

- Certificate of Good Manufacturing Practice (GMP) issued by the competent authority for the production facility.

- Report on the circulation process of the drug (Model 8-DR).

- Drug sample: one packaged unit for each registered format.

For drugs produced at one facility and packaged at another, the file must include:

- Certificate of Good Manufacturing Practice (GMP) for the production facility issuing intermediate products.

- Certificate of Good Manufacturing Practice (GMP) for the packaging facility.

- Marketing Authorization Certificate (FSC) for the drug issued by the competent authority in the country where the packaging or production facility is located.

Chapter 4

REGISTRATION FILE FOR LICENSED MANUFACTURED DRUGS

Article 20. The registration file for licensed manufactured drugs between domestic production facilities includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form for licensed manufacturing (Form No. 4C-DR).

- Summary of drug characteristics (Model 6-DR)

- Transfer agreement of production rights between the licensing facility and the receiving facility.

- Marketing Authorization Certificate for the drug to be transferred.

- Certificate of Good Manufacturing Practice (GMP) for the receiving facility issued by the competent authority.

- Technical standards and testing methods of the licensing facility.

- Test report of the drug from the receiving facility.

- Production process of the licensing facility.

- Research data on drug stability.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

Article 21. The registration file for licensed manufactured drugs from abroad for domestic production facilities includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form for licensed manufacturing (Form No. 4C-DR).

- Summary of drug characteristics (Model 6-DR)

- Marketing Authorization Certificate for licensed manufacturing issued by the competent authority (FSC).

- Certificate of Good Manufacturing Practice (GMP) for the facility holding the licensed manufacturing right.

- Certificate of Good Manufacturing Practice (GMP) for the receiving facility.

- Transfer agreement of production rights between the licensing facility and the receiving facility.

- Production process of the licensing facility.

- Quality standards and testing methods of the licensing facility.

- Test report of the drug from the receiving facility.

- Research data on drug stability.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: one packaged unit for each registered format.

Article 22. The re-registration file for licensed manufactured drugs includes:

- Cover page (Model 1-DR).

- Table of contents of the dossier (Model 2-DR).

- Application form (Form No. 5C-DR).

- Summary of drug characteristics (Model 6-DR)

- Drug label (designed or attached to Model 7-DR).

- Report on the circulation process of the drug (Model 8-DR).

- Drug sample: one packaged unit for each registered format.

Chapter 5

PROVISIONS ON TRIAL USE OF DRUGS TO EVALUATE SAFETY AND EFFICACY ON VIETNAMESE PATIENTS

Article 23. Drugs that are not new but are being used for the first time in Vietnam, when necessary, must undergo trial use to evaluate their effects to confirm their indications, contraindications, dosage, toxicity, side effects, and safety when used on Vietnamese patients.

The entity conducting the trial use must prepare a complete file according to Article 25 of Chapter V and can only proceed with the trial use upon obtaining written approval from the Ministry of Health.

Article 24. The entity conducting the trial use must be places such as hospitals, central institutes with patient beds, equipped with technical facilities, and staffed with qualified personnel to conduct trials and handle adverse events. The entity providing the drug for trial use is the production facility or the registration entity. Both parties must fully assume responsibility for the quality and safety during the drug trial on Vietnamese patients.

Article 25. The application for trial use of drugs on Vietnamese patients must be prepared in three copies, including at least one original copy or a certified copy. Each file includes:

- Application for trial use of drugs on Vietnamese patients.

- Trial use contract between the trial use entity and the drug provider, clearly defining each party's responsibilities regarding the trial use.

- Marketing Authorization Certificate (FSC) issued by the competent authority.

- Trial use protocol: The detailed protocol must be confirmed by the director of the trial use entity.

- Summary of drug characteristics (Form No. 6-DR).

- Standards and testing methods (detailed).

- Test report of the batch of drug proposed for trial use.

- Drug label (designed or attached to Model 7-DR).

- Drug sample: One unit package for each trial specification.

Chapter 6

HANDLING VIOLATIONS

Article 26. Registered drugs will be suspended from circulation and have their registration number revoked under the following circumstances within the validity period of the registration number:

- Suspension of circulation for batches of drugs that do not meet the registered quality standards.

- Revocation of the registration number for drugs produced contrary to the registration file, drugs with three batches failing to meet quality standards within a year, or drugs violating once but seriously. The Ministry of Health will stop accepting registration files and issuing registration numbers for a period of time for entities whose drugs violate regulations.

- For foreign drugs: If three or more drugs from a single production facility are revoked within a year, all drugs from that facility will be suspended from circulation. If three or more drugs from a single registration entity are revoked within a year, the operation license of the facility in the pharmaceutical sector in Vietnam may be revoked.

- Trial use of drugs to evaluate safety and efficacy on Vietnamese patients without written permission from the Ministry of Health will be handled according to the law.

- Drugs violating intellectual property rights will be handled according to the law.

Article 27. The Ministry of Health will announce decisions to suspend circulation, revoke registration numbers, and recall drugs that do not meet quality standards or are inconsistent with the registration file nationwide. Provincial Health Departments will announce decisions to suspend circulation and recall drugs that do not meet quality standards or were produced inconsistently with the registration file within their jurisdiction. When there is a decision to revoke registration numbers, suspend circulation, and recall drugs, relevant authorities will inspect and handle violations by the entities according to the law.

Article 28. Pharmaceutical production and trading entities must fully assume responsibility for any drugs violating the above regulations, and will be dealt with according to the law depending on the severity of the violation.

Chapter 7

IMPLEMENTING PROVISIONS

Article 29. The facilities must take proactive measures to monitor, detect, and immediately recall drugs that do not meet quality standards or violate current regulations, and report to the competent authority.

Article 30. For drugs that have been assigned registration numbers, if there is a notification from the Intellectual Property Office concluding that the trademark or design violates intellectual property rights during the validity period of the registration number, the facilities must cease production and importation of these drugs. Units must proceed with the procedures to request permission from the Ministry of Health when changing the trademark or industrial design of the drug.

Article 31. The Vietnam Drug Administration is responsible for receiving drug registration files, reviewing them, organizing meetings of the Drug Review Board, signing decisions to issue lists of drugs granted registration numbers, and other tasks related to drug production and circulation registration.

Form Number 1-DRK - Cover Page

DRUG REGISTRATION FILE

Name and address of the registering entity: Drug name - concentration, dosage:

Name and address of the drug manufacturing entity: Drug formulation:

YEAR:

Form Number 2-DRK

CONTENTS OF THE DRUG REGISTRATION FILE

Page

1. Registration Application

2. Summary of Drug Characteristics

3. Circulation Permit for Drugs (for imported drugs)

4. Certificate of Good Manufacturing Practice Compliance

5. Label Sample

6. Quality Standards and Testing Methods

7. Test Reports

8. Production Process

9. Research Documentation on:

Drug Stability

Preclinical Pharmacology

Toxicity

Clinical Pharmacology

Pharmacokinetics and Bioavailability

10. Other Documents

Form Number 3A-DRK

APPLICATION FOR RAW MATERIAL REGISTRATION FOR DRUG PRODUCTION

DOMESTIC PRODUCTION

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

 

Packaging Specifications

 

Form Number 3B-DRK

APPLICATION FOR RAW MATERIAL REGISTRATION FOR IMPORTED DRUGS

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

 

Packaging Specifications

 

Form Number 4A-DRK

APPLICATION FOR DOMESTIC DRUG PRODUCTION REGISTRATION

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

 

Formula for the smallest unit of packaging:

Ingredients: Dosage:

.......................................................................................................................

.......................................................................................................................

Origin of the formula:

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 4B-DRK

APPLICATION FOR IMPORTED DRUG REGISTRATION

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

Formula for the smallest unit of packaging:

Ingredients: Dosage:

.......................................................................................................................

.......................................................................................................................

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 4C-DRK

APPLICATION FOR LICENSED DRUG PRODUCTION REGISTRATION

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

Formula for the smallest unit of packaging:

Ingredients: Dosage:

....................................................................................................................

....................................................................................................................

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 5A-DRK

APPLICATION TO REISSUE DOMESTIC DRUG REGISTRATION NUMBER

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

Formula for the smallest unit of packaging:

Ingredients: Dosage:

...................................................................................................................

...................................................................................................................

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 5B-DRK

APPLICATION TO REISSUE IMPORTED DRUG REGISTRATION NUMBER

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

Formula for the smallest unit of packaging:

Ingredients: Dosage:

...................................................................................................................

..................................................................................................................

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 5C-DRK

APPLICATION TO REISSUE LICENSED DRUG REGISTRATION NUMBER

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

Formula for the smallest unit of packaging:

Ingredients: Dosage:

.................................................................................................................

.................................................................................................................

Indications, Dosage:

Contraindications, Caution:

Side Effects:

Packaging Specifications:

 

Form Number 6-DRK

SUMMARY OF DRUG CHARACTERISTICS

1. Drug Name:

1.1. Drug Name:

1.2. Dosage (Formula):

1.3. Drug Formulation:

2. Qualitative and Quantitative Analysis:

2.1. Qualitative Declaration.

The active ingredient must be declared according to the recommended INN name, accompanied by its salt form or hydrate if present.

2.2. Quantitative Declaration

The quantitative value of the active ingredient must be stated for each dose (for products with divided doses, calculated per spray), either by weight or mass.

3. Drug Formulation:

Description of the product appearance (color, signs, etc.), e.g., "white round tablets with a diagonal cross embossed with the number "100" on one side."

4. Clinical Characteristics:

4.1. Therapeutic Indications

4.2. Dosage and Administration

4.3. Contraindications.

4.4. Special Warnings and Precautions for Use.

4.5. Interactions with Other Drugs, Other Types of Interactions.

4.6. Use During Pregnancy and Breastfeeding.

4.7. Impact on Driving and Operating Machinery.

4.8. Adverse Drug Reactions.

4.9. Overdose.

5. Pharmacological Characteristics:

5.1. Pharmacodynamic Characteristics

5.2. Pharmacokinetic Characteristics

5.3. Preclinical Safety Data

6. Drug Characteristics:

6.1. List of Excipients

6.2. Compatibility

6.3. Shelf Life

The shelf life of the drug product as indicated on the label for sale. The shelf life of the prepared or dissolved drug. The shelf life of the drug after opening the package.

6.4. Special Storage Instructions.

6.5. Packaging Container Properties and Capacity.

7. Holder of the Circulation Permit.

8. Circulation Permit Number:

9. First Issue/Reissue Date of the Circulation Permit.

10. Date of Reapproval of the Product Summary Characteristics.

Form Number 7-DRK

DRUG LABEL SAMPLE

1. Direct Label of the Smallest Unit Package:

2. Intermediate Label

3. Prescription Instructions for Use:

Director of the Drug Manufacturing Facility

(Signature, full name, stamp)

Form Number 8-DRK

DRUG MARKETING REPORT
(From the date of registration number issuance to re-registration)

1. Registering Entity's Name: Manufacturing Entity's Name:

Address: Address:

Phone Number: Phone Number:

Fax Number: Fax Number:

2. Drug Name with Registered Number:

3. Drug Formulation (Specify the Formulation Type):

4. Marketed:

Yes No

5. Quality Range:

Yes No

If applicable, specify:

- Number of Violations:

- Type of Violation:

6. Violations of Regulations Related to Drug Registration and Marketing:

Yes No

If violations occurred, specify:

- Number of Violations:

- Type of Violation:

7. Changes During the Validity Period of the Registration Number Compared to the Approved Registration File:

Yes No

If changes occurred, attach a copy of the approval letter.

8. Changes at Re-registration (Registration Number Expired) Compared to the Approved Registration File:

Yes No

If changes occurred, clearly state the differences compared to the approved registration file.

If no changes occurred, the entity must commit to having no changes compared to the approved registration file.

Form Number 9A-DRK

APPLICATION FOR CHANGES/SUPPLEMENTS FOR DOMESTIC DRUGS

Respectfully submitted to: Ministry of Health

138 Giang Vo Street, Hanoi

Request the Ministry of Health to consider and resolve changes/supplements for the following drug:

Formula for the smallest unit of packaging:

Ingredients: Dosage:

.........................................................................................................................

.........................................................................................................................

Content of Change/Supplement Request:

.........................................................................................................................

.........................................................................................................................

Note: The content of changes/supplements is specified in Article 7.

The entity commits to maintaining all other contents consistent with the drug registration file kept at the Ministry of Health.

Form Number 9B-DRK

APPLICATION FOR AMENDMENT/ADDITION OF FOREIGN MEDICINES

Respectfully submitted to: Ministry of Health

138 Giang Vo Street, Hanoi

Request the Ministry of Health to consider and resolve changes/supplements for the following drug:

Formula for the smallest unit of packaging:

Ingredients: Dosage:

.........................................................................................................................

...Content of the amendment/addition request:

.........................................................................................................................

.........................................................................................................................

Note: The content of changes/supplements is specified in Article 7.

The entity commits to maintaining all other contents consistent with the drug registration file kept at the Ministry of Health.

Form No. 9C-ĐKT

APPLICATION FOR AMENDMENT OF THE REGISTERED PHARMACEUTICAL ESTABLISHMENT

Respectfully submitted to: Ministry of Health

138A Giang Vo Street, Hanoi

 

Appendix 1:

LIST

SUBMISSION OF MEDICINE REGISTRATION DOCUMENTS TO LOCAL HEALTH DEPARTMENT
(Annexed to Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 of the Ministry of Health)