✦ 스마트 요약
Circular No. 22/2009/TT-BYT stipulates the registration of medicines for circulation in Vietnam, applicable to agencies, organizations, and individuals both within and outside Vietnam involved in medicine registration activities. This circular aims to ensure the quality, safety, and efficacy of medicines when circulating in the market.
적용 범위
Agencies, organizations, and individuals both within and outside Vietnam involved in the registration of medicines for circulation in Vietnam.
핵심 사항
- The registration entity must have a Certificate of Business Conditions or a Registration License for Operation in accordance with the regulations of the Ministry of Health.
- New medicines and medicines derived from herbal sources need to be granted a registration number for circulation, while generic medicines only need to submit a quality dossier.
- Medicine manufacturing facilities must meet WHO GMP standards or equivalent to ensure product quality.
- The medicine registration dossier includes administrative and product information, quality, preclinical, and clinical sections (if necessary).
- The validity period of the registration number is five years, which may be extended in certain special cases.
- The Drug Administration is responsible for receiving, reviewing, and issuing the registration number for circulating medicines.
🌐 이 문서의 사회적 영향
- Positive impact: Ensuring the quality, safety, and efficacy of medicines when circulating in the market.
- Negative impact: Increasing costs for production facilities due to GMP-WHO requirements and complex registration dossiers.
❓ 자주 묻는 질문
Which entities need to have a certificate of business conditions for medicines?
Domestic medicine trading establishments or foreign medicine trading establishments must have a Certificate of Business Conditions for Medicines in accordance with the regulations of the Ministry of Health.
Which medicines need to be granted a registration number for circulation?
New medicines, medicines derived from herbal sources, and generic medicines all need to be granted a registration number for circulation. Medicines that already have an active registration number only need to submit a major or minor change dossier.
What standards must medicine manufacturing facilities meet?
Domestic medicine manufacturing facilities must meet WHO GMP standards, while foreign facilities must meet equivalent or higher standards.
What does the medicine registration dossier include?
The medicine registration dossier includes administrative and product information, quality, preclinical (if necessary), and clinical (if necessary) sections.
What is the validity period of the registration number?
The validity period of the registration number is five years. It may be extended in certain special cases.
전문
CIRCULAR
Regulations on drug registration
BASED on Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to the Drug Law dated June 14, 2005;
Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;
CONSIDERING the proposal of the Director of the Drug Administration Department,
Ministry of Health stipulating THE REGISTRATION OF DRUGS FOR USE BY HUMANS TO BE CIRCULATED IN VIETNAM shall be as follows:
PART I
GENERAL PROVISIONS
Article 1. Scope of regulation, applicable subjects điều chỉnh, đối tượng áp dụng
Clause 1. This Circular stipulates the registration of drugs for use by humans to be circulated in Vietnam.
No. 50/2015/TT-BYT dated December 11, 2015 of the Minister of Health prescribing the inspection of hygiene and water quality for drinking and domestic purposesư này This Circular applies to domestic and foreign agencies, organizations, and individuals involved in activities related to drug registration for circulation in Vietnam.
In cases where international treaties to which the Socialist Republic of Vietnam is a member have provisions different from those of this Circular, the provisions of such international treaties shall apply.
Article 2. Interpretation of Terms
In this Circular, the following terms are understood as follows:
Point 1. Drugs are substances or mixtures of substances intended for human use for the purpose of preventing, treating, diagnosing diseases, or regulating physiological functions of the body, including finished drugs, raw materials for drugs, vaccines, medical biological products, except functional foods.
Point 2. Chemical drugs are drugs containing active ingredients with defined composition, formula, and purity.
Point 3. Raw materials for drugs are substances participating in the formulation of products during the drug production process.
Point 4. Drugs from herbal medicines are drugs produced from natural sources derived from animals, plants, or minerals.
Drugs with purified active ingredients extracted from natural herbal sources, or drugs combining herbal medicines with synthetic chemical compounds, are not considered drugs from herbal medicines.
Point 5. Traditional medicine drugs are drugs made from herbal medicines formulated according to the theory and methods of traditional Eastern medicine.
Point 6. Vaccines are preparations containing antigens capable of inducing immune responses in the body, designed for disease prevention.
Point 7. Medical biological products are biologically sourced products manufactured for disease prevention, treatment, and diagnosis in humans.
Point 8. Active ingredient is a substance or mixture of substances with therapeutic activity used in drug production.
Point 9. New active ingredient is an active ingredient that is first registered for circulation in Vietnam in the composition of a drug.
Point 10. New drug is a drug first registered in Vietnam, including:
Subpoint a. A drug containing a new active ingredient;
Subpoint b. A drug with a new combination of active ingredients already circulating in Vietnam.
Point 11. Finished drug is a form of drug that has undergone all stages of production, including final packaging and labeling.
Point 12. Generic drug is a finished drug intended to replace an original drug produced without a license from the original company and introduced to the market after the expiration of the patent or other exclusive rights.
Point 13. Licensed production drug is a drug of a domestic or foreign production facility that has been granted a registration number for circulation (in Vietnam or abroad) and transferred the right to produce to another facility meeting the conditions for drug production in Vietnam.
Point 14. Trade name of a drug is a name different from the generic name or the international nonproprietary name.
Point 15. ASEAN Common Technical Document (ACTD) is a set of guidelines for drug registration files meeting the common technical requirements of the Association of Southeast Asian Nations (ASEAN).
Point 16. Re-registration is the submission of a drug registration file when the registration number of a drug has expired.
Point 17. Change refers to any difference in a drug or raw material for drugs that has been granted a registration number, including changes in formula, production method, production location, finished product or raw material standards, packaging, labeling, and product information.
Point 18. Major change refers to changes that may affect one of the following factors of a drug that has been granted a registration number for circulation:
a) Indications;
Subpoint b. Route of administration;
Subpoint c. Concentration, dosage;
Subpoint d. Changes that are not minor changes
Point 19. Minor change refers to changes that do not affect one of the following factors of a drug that has been granted a registration number for circulation:
a) Indications;
Subpoint b. Route of administration;
Subpoint c. Concentration, dosage;
Subpoint d. Dosage;
Subpoint e. Active ingredient.
Point 20. Other changes refer to changes that do not fall under Clauses 18 and 19 of this Article.
Point 21. Country of origin is the country producing the final formulation and/or dispatching a batch or the country where the product is transported to the importing country.
Point 22. Registration entity is the entity named in the application for issuance of a circulation permit, submission of updated or changed documents of a drug that has been granted a registration number.
Point 23. Production entity is the entity performing at least one stage of production and/or dispatching finished products.
Article 3. Prohibited acts
Point 1. Forgery or unauthorized alteration of registration files, documents, or legal papers of Vietnamese or foreign competent management agencies.
Point 2. Using counterfeit stamps or forging signatures or seals of the registration entity, production entity, and related entities in drug registration files.
Article 4. Provisions for drug registration entities
1. Drug registration entities must have a Certificate of Eligibility for Pharmaceutical Business in Vietnam if they are domestic pharmaceutical business entities, or a License to operate in the pharmaceutical sector in Vietnam if they are foreign pharmaceutical business entities, in accordance with the regulations of the Ministry of Health.
2. Drug registration entities shall have the following rights and responsibilities:
a) To be guided on drug registration and to know information related to the drug submitted by the named entity;
b) Request withdrawal of the drug registration number when necessary (Form 6/TT);
c) Lodge complaints against decisions of competent authorities related to the issuance of drug circulation registration numbers. The procedures, formalities, and complaint authority shall be carried out in accordance with the laws on complaints and denunciations;
d) Be responsible for the quality, safety, and efficacy of drugs and ensure that circulating drugs comply with the registration dossier;
đ) Be responsible for all information provided in the application form and documents included in the dossier. Ensure that all data, reports, and information currently available regarding the benefits and risks of the drug are fully provided at the time the registration dossier is submitted to the Drug Administration Department;
e) Provide relevant information concerning submitted data or additional information for review during the drug registration and circulation process upon request from the Drug Administration Department;
g) Report to the Drug Administration Department new information related to the quality, safety, and efficacy of drugs when such information has not been updated in the submitted dossier and/or is still under review at the Drug Administration Department, as well as when the drug is still circulating in the market; changes to the drug's dossier compared to the registration dossier during the validity period of the registration number, including changes not listed in Appendix II of this Circular;
h) Notify and clearly state the reasons to the Drug Administration Department and other relevant state management agencies in case the drug registration number remains valid in Vietnam but the drug’s circulation permit is revoked in any country worldwide;
i) Cooperate with import entities and production entities to withdraw non-compliant drugs from the market according to regulatory requirements or self-discovered issues; report the results of the withdrawal and propose handling solutions;
k) Annually submit a written report to the Drug Administration Department on registered drugs that are circulating;explain the reasons for cases where registered drugs are not produced (for domestic drugs) or imported (for foreign drugs) (Form 8/TT);
l) Maintain complete dossiers and provide them to competent state management authorities upon request;
m) Cooperate and facilitate inspections and evaluations of production facilities upon request from the Drug Administration Department; bear responsibility for funding inspection and evaluation costs before or after the drug receives a circulation registration number in Vietnam; for inspections and evaluations of production facilities before or after the drug receives a circulation registration number in Vietnam.
Article 5. Provisions for drug manufacturing entities
1. Domestic drug manufacturing entities must have a Certificate of Eligibility for Pharmaceutical Business and a certificate of compliance with Good Manufacturing Practice (GMP) standards in accordance with the regulations and the implementation schedule of GMP set forth by the Ministry of Health.
2. Foreign drug manufacturing entities must meet equivalent or higher Good Manufacturing Practice (GMP) standards as recommended by the World Health Organization (GMP-WHO). In cases where certificates of compliance with GMP standards or certificates of pharmaceutical product compliance (CPP) do not explicitly state that the manufacturing entity meets GMP-WHO standards, the registration entity must provide evidence proving that the GMP standards met by the manufacturing entity are not lower than GMP-WHO standards.For in vitro diagnostic products, the manufacturing entity must meet GMP, ISO, or other equivalent certification standards. If necessary, the Drug Administration Department will conduct an assessment and inspection of the manufacturing facility before or after issuing the circulation registration number.
3. Drugs must be manufactured at facilities with production licenses issued by competent authorities for the specific investment and construction facilities that meet the production conditions stipulated in Clause 2 of this Article (except for drugs manufactured under contract manufacturing arrangements); they may not be produced at other facilities through borrowed production licenses (Loan License).
4. Drug manufacturing entities shall have the following rights and responsibilities:
4. For investment projects specified in Clause 5, Article 38 of this Decree:be guided on drug registration and informed of information related to drugs produced by their entity and registered in Vietnam;
b) Request withdrawal of the drug registration number in cases where the drug has quality, safety, and efficacy issues affecting user health, without necessarily obtaining consent from the drug registration entity (Form 6/TT);
c) Lodge complaints against decisions of competent authorities related to the issuance of drug circulation registration numbers. The procedures, formalities, and complaint authority shall be carried out in accordance with the laws on complaints and denunciations;
d) Be responsible for ensuring that drugs meet quality, safety, and efficacy standards and are produced in accordance with the registration dossier approved by the Ministry of Health;
đ) cooperate with import entities and drug registration entities to withdraw non-compliant drugs from the market according to regulatory requirements or self-discovered issues; report the results of the withdrawal and propose handling solutions;
e) Cooperate with drug registration entities to report to the Drug Administration Department and other relevant agencies any new information related to the quality, safety, and efficacy of drugs when such information has not been updated in the submitted dossier and/or is still under review at the Drug Administration Department, as well as when the drug is still circulating in the market; changes to the drug's dossier compared to the registration dossier during the validity period of the registration number, including changes not listed in Appendix II of this Circular;
g) Notify and clearly state the reasons to the Drug Administration Department and other relevant state management agencies in case the drug registration number remains valid in Vietnam but the drug’s circulation permit is revoked in any country worldwide;
h) Maintain complete records of pharmaceutical products produced and provide such records to competent state management authorities upon request;
i) Prepare adequate means and working conditions for inspection and evaluation of production facilities when requested by the Drug Administration Department; cooperate with the drug registration entity to cover the costs for serving such inspections; for inspections and evaluations of production facilities before or after the drug receives a circulation registration number in Vietnam.
Article 6. Provisions for franchised production facilities and commissioned drug production; drugs produced under contract manufacturing.
1. For herbal medicines, vaccines, serum containing antibodies, medical biological products: franchising and receiving franchised production facilities must at least meet the GMP-WHO standards; for in vitro diagnostic medical biological products: GMP, ISO, or equivalent standards.
2. For traditional medicine drugs, drugs from medicinal materials, raw materials for drug production:
a) Overseas franchising facilities must at least meet the GMP-WHO standards. Domestic franchising facilities shall implement the roadmap for applying GMP as stipulated by the Ministry of Health;
b) Franchisees shall implement the roadmap for applying GMP as prescribed by the Ministry of Health.
3. For drugs produced under contract manufacturing, provisions currently in force by the Ministry of Health for contract-manufactured drugs shall be followed;
Article 7. Requirements for drug testing certificates
1. For chemical drugs, medical biological products, traditional medicine, and drugs derived from medicinal materials:
a) Pharmaceutical production facilities that meet the GMP standards shall self-assess their compliance, conduct testing, and submit their own testing certificates when filing registration applications;
b) In cases where domestic pharmaceutical production facilities have not yet met the GMP standards, the drug registration entity must conduct a standard assessment at one of the national drug testing facilities or private enterprises providing drug testing services that hold a Business Registration Certificate and meet the professional standards set by the Ministry of Health;
2. For vaccines, serum containing antibodies, in vitro diagnostic medical biological products:
a) Vaccine and serum containing antibody registration entities must conduct a standard assessment and submit testing certificates issued by the National Institute for Vaccine and Medical Biological Product Control;
b) Registration entities for in vitro diagnostic medical biological products may use their own testing certificates if the production facility meets the GMP standards or equivalent standards. If the production facility does not meet the GMP or ISO standards or equivalent standards, the registration entity must conduct a standard assessment and submit testing certificates issued by the National Institute for Vaccine and Medical Biological Product Control;
3. During the review of drug registration applications, when requested by the Drug Administration Department, the drug registration entity must re-evaluate the standards and testing methods at testing facilities designated by the Ministry of Health. The requirements for re-evaluating standards and testing methods are specified in Appendix IV of this Circular;
Article 8. Clinical trial requirements related to new drug registration
New drugs seeking circulation in Vietnam must conduct clinical trials in accordance with the clinical trial regulations established by the Ministry of Health;
Article 9. Requirements for bioavailability and bioequivalence of drugs
The submission of research data reports on the bioavailability and bioequivalence of registered drugs shall be carried out in accordance with the regulations on submitting bioavailability and bioequivalence research data reports issued by the Ministry of Health.
Article 10. Provisions on language, form of application dossier, drug samples, and fees
1. Languages used in the application dossier:
a) Application dossiers for domestically produced medicines must be written in Vietnamese;
b) The application dossier for foreign drugs must be written in Vietnamese or English. In cases where the dossier is written in English, all information in the Drug Usage Guide, Product Summary Characteristics, or Patient Information must be written in Vietnamese.
2. The drug registration dossier must be prepared on A4 size paper, securely bound. The dossier must be arranged in accordance with the table of contents, with clear divisions between sections. Each section must be numbered sequentially for easy reference and must have confirmation from the registering entity or the drug manufacturing entity at the beginning of each section within the entire dossier.
3. Each medicine must have its own separate application dossier, except in cases where medicines share all of the following factors and can be registered in the same dossier:
a) Medicine name;
b) Formulation type;
c) Formula for a single dose (for single-dose formulations) or the same concentration (for multi-dose formulations);
d) Manufacturer;
4. General requirements for documents to be submitted in the initial registration dossier, re-registration dossier, and other change request dossiers are as follows:
a) One original copy including all required documents as stipulated in Clause 1 and 2 of Article 17 for chemical drugs, vaccines, antibody-containing sera, medical products (excluding in vitro diagnostic products), Clause 1 and 2 of Article 22 for in vitro diagnostic products, and Clause 1 and 2 of Article 26 for herbal drugs, traditional Chinese medicine, and raw materials for drug production;
b) Two copies of documents including the drug registration form and finished product standards;
c) Drug labels: two sets of label design samples, for foreign drugs, one set of original labels currently circulating in the country of origin must be attached. These labels must be affixed to A4 paper stamped with an overlapping seal of the registering entity or the drug manufacturing entity;
d) Product information: a Usage Guide, Patient Information, or Product Summary Characteristics according to the regulations applicable to each type of drug, as follows: stamped with an overlapping seal of the registering entity or the drug manufacturing entity;
đ) Medicine samples, raw materials for medicine:
- One unit of packaging for one registered circulation specification;
- Sufficient quantity for three testing cycles for raw materials;
- For vaccines, serum containing antibodies, the registering entity must send samples for storage at the National Institute of Vaccines and Medical Biological Products;
e) Product summary (Form 7/TT).
5. For large and small change registration dossiers: one original copy containing all required documents according to the changes being requested, as stipulated in Clause 4 and 5 of Article 17 for chemical drugs, vaccines, antibody-containing sera, medical products, Clause 3 and 4 of Article 22 for in vitro diagnostic products, and Clause 3 and 4 of Article 26 for herbal drugs, traditional Chinese medicine, and raw materials for drug production.
6. Legal document requirements:
a) Drug Product Certificate (CPP), Free Circulation Certificate (FSC), Good Manufacturing Practice (GMP) Certificate or equivalent certificates for in vitro diagnostic products may be submitted as originals, copies, or Vietnamese translations from foreign languages but must comply with specific regulations for each type of certificate as provided in point b, c, or d of this clause and general provisions as follows:
- In case of submitting originals: The original must contain complete signatures, full names, titles of signatories, and stamps of competent authorities issuing the certificates in the country of origin; it must be legalized by the Vietnamese diplomatic mission according to the laws on legalization of foreign public documents, except for legal documents issued by competent authorities of countries that have signed Mutual Legal Assistance Agreements with Vietnam.
- In case of submitting copies: Copies must be certified as true copies by competent Vietnamese authorities according to Vietnamese laws on certification of copies.
- In case of submitting Vietnamese translations from foreign languages: The Vietnamese translation must be notarized according to regulations (here, notarization means the signature of the translator must be certified by a local Notary Public Office, Diplomatic Mission, Consular Office, or another authorized foreign agency according to the law) and must be accompanied by the original or certified copy of the certificate as specified above.
- Validity period of certificates: The validity period must be clearly stated on the certificates and must still be valid at the time of evaluation; extension letters for these certificates will not be accepted. If the certificate does not specify the validity period, only certificates issued within 24 months from the date of issuance will be accepted.
b) The Drug Product Certificate (CPP) in addition to complying with the provisions in point a of this clause must also meet the following requirements:
- It must confirm that the drug is permitted to circulate in the country of origin; if the drug is not circulating in the country of origin, the registering entity must provide an explanation for the Ministry of Health to consider;
- In cases where the drug is produced through multiple stages in different countries and cannot determine a single country of origin, the registering entity must submit the CPP of the country producing the final formulation or the CPP of the country exporting the batch. If there is no CPP from both countries of origin mentioned above, the Ministry of Health will consider accepting the CPP of the country where the product is transported to the importing country;
- In cases where there is no CPP from the countries of origin mentioned above, only the CPP issued by the competent authority of one of the United Kingdom, France, Germany, USA, Japan, Australia, Canada, or the European Medicines Agency (EMA) will be accepted;
- Issued by the competent drug regulatory authority (listed on the WHO website http://www.who.int)of the country of origin) according to the WHO model applicable to the Quality Certification System for pharmaceutical products circulating in international trade.
c) The Free Circulation Certificate (FSC) in addition to complying with the provisions in point a of this clause must also meet the following requirements:
- It must confirm that the drug is permitted to circulate in the country of origin; if the drug is not circulating in the country of origin, the registering entity must provide an explanation for the Ministry of Health to consider;
- Issued by the competent authority in the country of origin, containing all necessary information about ingredients, dosage forms, and the validity period of the certificate.
d) The Good Manufacturing Practice (GMP-WHO), ISO or equivalent certificates must be issued by the competent authority in the country of origin, confirming the name and address of the manufacturer.
đ) The Business Registration Certificate for drug trading must be an original or certified copy authenticated by a competent state authority in Vietnam, still valid, and issued by the competent authority according to current regulations.
e) A valid business operation certificate of the foreign enterprise regarding drugs and drug raw materials in Vietnam, which must be original or a certified copy issued by the registration authority abroad or the representative office in Vietnam;
g) Certificates of protection, industrial property rights certificates, and transfer agreements related to the subject matter of industrial property in the drug registration dossier (if any), issued or confirmed by competent authorities on industrial property, must be originals or certified copies stamped by the drug registration authority;
7. Provisions for Other Administrative Documents:
a) The application form must be signed directly on the form by the director of the registering entity or an authorized representative of the registering entity, and stamped (if applicable) by the registering entity, electronic signatures will not be accepted.
b) An authorization form according to Model 3/TT and required to be submitted in the following cases:
- DECREES:Authorization for the registration entity to be named (Model 3A);
- Authorization for signing the drug registration dossier when the drug registration entity authorizes its representative office in Vietnam to sign the drug registration dossier (Model 3B);
- DECREES:Authorization for using the name of a registered trademarked drug when the owner of the trademark is not the drug registration entity (Model 3C).
Each application must be accompanied by an original power of attorney or a certified copy of the original power of attorney confirmed by the registering entity or the representative office in Vietnam.
c) A copy of the franchise agreement for drugs produced under a franchise arrangement.
8. Regulations on drug labels and product information:
The content of drug labels and product information shall comply with current regulations of the Ministry of Health on drug labeling and/or the provisions of ACTD.
9. Fee regulations:
The drug registration entity must pay relevant fees for drug registration and circulation in accordance with current laws on fees and charges.
Article 11. Regulations on drug naming
1. The Ministry of Health encourages registration entities to use international non-proprietary names (INN) for medicine names.
2. In cases where the drug is not named according to the INN, the drug registration entity may use a trade name but must ensure compliance with the following principles:
a) Not to advertise exaggerated therapeutic effects of the drug;
b) Not to reflect false therapeutic effects of the drug, not to cause confusion about the pharmacological group of the drug; drugs with different active ingredients must have different names;
c) Not violating Vietnamese customs, traditions, and aesthetic values;
d) Not conflicting with intellectual property rights of other individuals or organizations that are protected;
đ) Not being identical or similar to the names of medicines already registered by other entities;
Article 12. Forms of drug registration
Chemical drugs, medical biological products, vaccines, antibody-containing sera, in vitro diagnostic products, traditional Chinese medicines, herbal medicines, and drug raw materials are registered in the following forms:
1. Initial registration;
2. Major change registration;
3. Minor change registration;
4. Re-registration.
Article 13. Validity of drug registration numbers
The maximum validity period of the drug circulation registration number is five years from the date of issuance of the Decision granting the registration number. For special cases, the Ministry of Health will examine and make specific regulations. Within six months before and after the expiration of the circulation registration number's validity period, the entity can submit a re-registration application. After this period, the entity must submit the application as if it were for initial registration.
Chapter II
INTELLECTUAL PROPERTY RIGHTS FOR REGISTERED DRUGS
1. Large electricity consumers or retail electricity suppliers in authorized zone or cluster models may purchase electricity from the Electricity Corporation to meet their entire demand.
1. The drug registration entity is responsible for intellectual property issues related to registered drugs.
2. The Ministry of Health encourages drug registration entities to establish intellectual property rights or conduct searches for related intellectual property objects before registering drugs for circulation in Vietnam.
3. In cases of intellectual property disputes during the examination for granting registration numbers, the party opposing the grant of a registration number for a drug involved in an intellectual property dispute must provide conclusions from the State management agency on intellectual property or the enforcement agency regarding acts of infringement. If there is sufficient basis to determine that the drug will infringe upon protected intellectual property rights when granted a registration number for circulation, the Ministry of Health will refuse to grant the registration number for circulation.
4. In cases of intellectual property disputes after the grant of a registration number for circulation, based on the request of the intellectual property right holder or a third party with a vested interest and the judgment of the Court or the final conclusion of the State management agency on intellectual property or the enforcement agency regarding acts of infringement, the Ministry of Health will decide to suspend or revoke the registration number for circulation for drugs found to infringe upon intellectual property rights.
Article 15. Patent-related applications for drug registration
1. For drugs containing active ingredients still within the intellectual property protection period, the applicant may provide legal documents related to the status of protection and intellectual property rights (patent certificates) for the registered drug (if applicable).
2. Within two years before a drug's patent protection expires, the drug registration applicants may submit an application for the circulation of generic drugs along with documents proving that the protected drug will soon expire and must clearly state the request in the application form (Form 2A/TT).
Article 16. Data confidentiality for registration files
Drug registration applicants who require data confidentiality for new drug registration files shall comply with the regulations on data confidentiality for drug registration files issued by the Ministry of Health and must clearly state the request in the application form (Form 2A/TT).
Chapter III
SPECIFIC PROVISIONS FOR DRUG REGISTRATION FILES
Section I.
REGISTRATION FILES FOR FINISHED CHEMICAL MEDICINES, VACCINES, IMMUNOGLOBULINS CONTAINING ANTIBODIES, AND MEDICAL BIOPRODUCTS
Article 17. Documents to be submitted
1. Initial registration file for new chemical drugs, vaccines, antisera containing antibodies, medical bioproducts, including:
a) Part I. Administrative File and Product Information;
b) Part II. Quality File;
c) Part III. Preclinical File;
d) Part IV. Clinical File.
2. Initial registration file for generic drugs (applicable only to chemical drugs), including:
a) Part I. Administrative File and Product Information;
b) Part II. Quality File;
3. Resubmission file, including:
a) Part I. Administrative files and product information;
b) Part II. Quality File;
c) Part III. Circulation report (Form 5/TT).
4. Files for major changes:
a) Part I. Administrative File and Product Information;
b) Part II. Quality File;
c) Part IV. Clinical File;
Major change contents and corresponding files to be submitted shall be carried out according to the guidelines in Section I-Appendix II of this Circular.
5. Files for minor changes:
a) Part I. Administrative File and Product Information;
b) Part II. Quality File;
Minor change contents and corresponding files to be submitted shall be carried out according to the guidelines in Section II-Appendix II of this Circular.
6. Files for other changes: See the guidelines in Section III-Appendix II of this Circular.
7. The files prescribed in Clause 1, 2, 3, 4, 5 and 6This Article must be implemented in accordance with the following provisions:
a) Apply the provisions in Appendix I of this Circular, including:
- ASEAN Common Technical Document (ACTD);
- Research Stability Guidance;
- Production Process Review Guidance;
- Hexamination guidelines on the method analysis;
- Bioavailability and Bioequivalence Study Guidance;
b) Structure according to the ACTD model. In cases where new chemical medicines, vaccines, immunoglobulins containing antibodies, and medical bioproducts cannot be arranged according to the ACTD model, they can be structured according to the Common Technical Document (ICH-CTD) model.
8. For manufactured drugs, requirements for the documents to be submitted shall be carried out in accordance with the current regulations of the Ministry of Health regarding drug manufacturing.
Article 18. Specific provisions for administrative files and product information
Administrative files and product information include:
1. Cover page - Form 1/TT;
2. Table of contents;
3. Application form - Form 2/TT;
4. Power of attorney (if any) - Form 3/TT;
5. Business license for foreign enterprises operating in Vietnam if the applicant is a foreign drug business entity, or a certificate of eligibility to operate drugs if the applicant is a domestic drug business entity.
6. Certificate of CPP Model 1/ACTD for imported drugs.
7. Certificate of FSC for cases where the foreign drug applicant does not have a CPP.
8. GMP certificate of domestic production facilities or GMP certificate of foreign drug production facilities if the drug applicant submits an FSC or CPP certificate without confirmation of the production facility meeting GMP standards.In cases where multiple production facilities participate in the production process, the drug applicant must submit GMP certificates from all production facilities involved in the production of finished products.
9. Drug labels.
10. Product information:
a) Drug usage instructions for generic drugs;
b) Product characteristics summary for new chemical drugs, vaccines, immunoglobulins containing antibodies, and medical bioproducts - Form 2/ACTD;
c) Information for patients for over-the-counter drugs - Form 3/ACTD.
11. Circulation report for resubmission files - Form 5/TT.
12. Licensing agreement or franchise contract for franchised-manufactured drugs.
13. Certificates, industrial property rights certificates, and transfer contracts of industrial property objects related (if any).
14. Other legal documents (if any).
Article 19. Specific provisions on quality dossier
The quality dossier shall be implemented according to the guidelines in Part II- ACTD and shall include the following documents:
1. Table of contents;
2. Summary of overall quality;
3. Content and data;
4. References;
5. Overall dossier of the production facility - Form 4/TT. In cases where a product is produced through multiple stages, the overall dossier must be the dossier of all manufacturers involved in producing the product before it enters the market.
Article 20. Specific provisions on preclinical dossier
The preclinical dossier shall be implemented according to the guidelines in Part III- ACTD and shall include the following documents:
1. Table of contents;
2. Summary of the preclinical study;
3. Abstract of the preclinical study;
4. Preclinical study report;
5. Reference materials.
Article 21. Specific provisions on clinical dossier
The clinical dossier shall be implemented according to the guidelines in Part IV- ACTD and shall include the following documents:
1. Table of contents;
2. Clinical overview;
3. Clinical summary;
4. List of clinical studies;
5. Clinical study report;
6. Reference materials.
Chapter II.
REGISTRATION FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
Article 22. Dossiers to be submitted
1. Initial registration dossier for diagnostic reagents, including semi-finished products, shall include:
a) Part I. Administrative file;
b) Part II. Quality File;
c) Part III. Diagnostic efficacy file, this provision does not apply to semi-finished products;
2. Re-registration file, includes:
a) Part I. Administrative file;
b) Part II. Quality File;
c) Part III. Circulation report (Form 5/TT).
3. Registration dossier for major changes shall be implemented according to the initial registration requirements as stipulated in Appendix III B of this Circular.
4. Registration dossier for minor changes, shall include:
a) Application form (according to the template);
b) Relevant parts of the dossier related to changes: submit corresponding parts of the dossier as specified in Appendix IIIA of this Circular.
Article 23. Specific provisions on administrative dossier and product information
The administrative dossier shall include the following documents:
1. Cover page - Form 1/TT
2. Table of contents.
3. Application form - Form 2/TT.
4. Product label
5. Power of attorney (if any) - Form 3/TT.
6. Business license for vaccine and medical product activities in Vietnam issued by the competent authority if the registering entity is a foreign enterprise, or Certificate of Eligibility for Vaccine and Medical Product Business if the registering entity is a Vietnamese enterprise.
7. Marketing authorization in the country of origin for foreign products, this provision does not apply to semi-finished products.
8. Good Manufacturing Practice (GMP) certificate or ISO certificate or equivalent standard certification of relevant production facilities during the production process issued by the competent authority.
9. Intellectual property certificates, economic contracts, other documents (if any).
Detailed content of the dossier shall be implemented according to the guidelines in Appendix IIIA of this Circular.
Article 24. Specific provisions on quality dossier
The quality file includes:
1. Table of contents;
2. Active ingredients;
3. Finished products;
4. Stability.
Detailed content of the dossier shall be implemented according to the guidelines in Appendix IIIA of this Circular.
Article 25. Specific provisions on efficacy evaluation dossier for diagnostic reagents
The efficacy file for in vitro diagnostic medical devices includes:
1. Table of contents;
2. Research reports.
Detailed content of the dossier shall be implemented according to the guidelines in Appendix III A of this Circular.
Chapter III.
REGISTRATION DOSSIER FOR DRUGS FROM PHARMACEUTICAL RAW MATERIALS, TRADITIONAL MEDICINE AND DRUG RAW MATERIALS
Article 26. Dossiers to be submitted
1. Initial registration documents, including:
a) Administrative documents and product information.
b) Quality documents.
c) Safety and efficacy documents applicable only to new drugs and new drug ingredients.
2. Re-registration file, includes:
a) Administrative documents and product information;
b) Quality documents;
c) Circulation report - Form 5/TT;
3. Registration dossier for major changes: the contents of major changes and corresponding dossiers to be submitted shall be implemented according to the guidelines in Section I-Appendix II of this Circular.
4. Registration dossier for minor changes: the contents of minor changes and corresponding dossiers to be submitted shall be implemented according to the guidelines in Section II-Appendix II of this Circular.
5. Registration dossier for other changes: shall be implemented according to the guidelines in Section III-Appendix II of this Circular.
Article 27. Specific provisions on administrative dossier and product information
The administrative dossier and product information shall be implemented according to Article 18 of this Circular.
Article 28. Specific provisions on quality dossier
1. Production process:
a) Raw materials:
- For drugs from pharmaceutical raw materials and traditional medicine: no requirement for production process for excipients and raw materials listed in the pharmacopoeia, or raw materials produced by another manufacturer. Other cases require detailed description of the production process of raw materials.
- For drug ingredients: a detailed description of the production process is required.
b) Finished products:
- Formula for the smallest unit of packaging: name of raw material including active ingredient and excipient; quantity or concentration of each raw material; applicable standards of raw material; if produced from extract, specify the corresponding amount of medicinal material;
- Formula for a batch or lot: name of raw materials including main components and excipients; quantity or volume of each raw material;
- Flowchart of the production process including all stages of production;
- Description of the production process: detailed description of each stage of the production process;
- List of equipment and tools used: name of equipment, specifications, purpose of use;
- Control during production: Detailed description of inspection and control criteria during production.
2. Quality standards and testing methods.
a) For raw materials listed in the pharmacopoeia, specify the name of the pharmacopoeia and year of publication; for raw materials not listed in the pharmacopoeia, provide a detailed description of specifications and testing methods.
b) Finished products:
- Formula for the smallest unit of packaging: Name of raw material including active ingredient and excipient; Quantity or concentration of each raw material; applicable standards of raw material; if produced from extract, specify the corresponding amount of medicinal material.
- Finished product standards: A detailed description of quality criteria and testing methods of finished products.
c) Packaging material standards: A detailed description of quality criteria and testing methods.
d) Drug test report shall be implemented according to Article 7 of this Circular.
đ) Stability research documentation, including:
- Research plan for stability;
- Stability research data;
- Stability study conclusions.
Article 29. Specific provisions on safety and efficacy registration files
Safety and efficacy documents for new drugs shall be carried out in accordance with the clinical trial regulations of the Ministry of Health, including:
1. Toxicology reports.
2. Clinical research reports, this regulation does not apply to ingredient registrations.
Chapter IV
PROCEDURES AND REQUIREMENTS FOR DRUG REGISTRATION AND AUTHORITY TO ISSUE, SUSPEND, AND REVOKE REGISTRATION NUMBERS
Article 30. Procedures and requirements for receiving and examining drug registration files
1. The Drug Administration of Vietnam under the Ministry of Health shall be responsible for receiving drug registration files submitted directly or sent via postal service in the following cases:
a) Initial registration files and re-registration files for drug registration files, except for those specified in Clause 2 of this Article;
b) Large change, small change, and other change files during the validity period of the drug registration number for all drugs that have been assigned a registration number.
2. Provincial Departments of Health where production facilities are located shall be responsible for receiving initial registration files and re-registration files submitted directly or sent via postal service for drugs used outside domestic production as specified in Appendix V of this Circular.
3. The Drug Administration shall organize the examination and submit to the Advisory Council of the Ministry of Health for assigning drug registration numbers for the files specified in point a, Clause 1 of this Article; respond in writing to requests for large changes, small changes, and other changes for drugs that have been assigned registration numbers still in effect as specified in point b, Clause 1 of this Article.
4. The Department of Health shall organize the examination of the files specified in Clause 2 of this Article and send to the Drug Administration a letter accompanied by a list of drugs requesting the Drug Administration to assign registration numbers.
Article 31. Authority to issue registration numbers
1. The Minister of Health authorizes the Director of the Drug Administration Department to issue decisions approving the list of drugs granted registration numbers in the following cases:
a) Drug registration files received and organized for examination by the Drug Administration according to point a, Clause 1 of Article 30 of this Circular;
b) Drug registration files received and organized for examination by the Department of Health according to Clause 2 of Article 30 of this Circular.
2. The Drug Administration shall be responsible for responding in writing to requests for large changes, small changes, and other changes for drugs that have been assigned registration numbers still in effect as specified in point b, Clause 1 of Article 30; handle matters related to production, registration, and circulation of drugs.
Article 32. Time limit for issuing registration numbers or responding to registration files for large changes, small changes, and other changes
1. Within six months from the date of receipt of complete valid files, the Ministry of Health shall issue circulation registration numbers for initial or re-registration drugs; if not or not meeting conditions to issue registration numbers, the Ministry of Health shall provide a written response and clearly state the reasons.
2. Within three months from the date of receipt of complete valid files, the Department of Health shall be responsible for organizing the examination and sending to the Ministry of Health a letter accompanied by a list of drugs requesting registration numbers for drugs whose files were received by the Department of Health according to Clause 2 of Article 30 for the Ministry of Health to consider and issue circulation registration numbers; if lacking sufficient basis to request registration numbers, the Department of Health must provide a written response to the registering entity and clearly state the reasons.
3. Within two months from the date of receipt of complete valid files, the Ministry of Health shall examine and respond to registration files for large changes and small changes.
4. For other change requests, the files shall be handled according to the regulations for re-registration files, and the time limit for responding shall be as stipulated in Clauses 1 and 2 of this Article.
5. The Ministry of Health shall prioritize examining and issuing registration numbers or providing written responses before the deadlines set out in Clauses 1 and 3 of this Article based on the request of the registering entity in the following cases:
a) Drugs that meet special treatment needs included in the List of Rare Medicines issued by the Ministry of Health;
b) Drugs needed for urgent treatment in emergency situations, natural disasters, or epidemics.
c) Domestic-produced drugs on new production lines that meet GMP standards within a period not exceeding 18 months from the date of obtaining GMP certification.
For drugs registered according to Clause 5 of this Article, the registering entity must clearly indicate the priority request for registration number issuance on the registration form (Form 2A/TT).
6. Assign the Drug Administration to developựng specific procedures guiding the supplementation of drug registration files suitable for practical situations at each specific stage.ừng giai đoạn cụ thể.
Article 33. Cases for Withdrawal of Drug Registration Numbers
Within the validity period of the registration number, the Ministry of Health shall consider and decide to withdraw the registration number for drugs that have been granted a registration number for circulation in the following cases:
1. Drugs produced not in accordance with the approved registration dossier unless permitted by the Ministry of Health;
2. Drugs having two batches failing quality standards or violating quality standards once but seriously, as concluded by the competent state agency responsible for drug quality management;
3. The production facility or the registration entity requests withdrawal of the registration number for circulation in Vietnam;
4. Drugs withdrawn from circulation in their country of origin;
5. Drugs containing active ingredients recommended by the World Health Organization and/or the competent authority of Vietnam or foreign countries as unsafe for users;
6. Drugs found to infringe intellectual property rights by competent authorities;
Article 34. Cases for Suspension of Acceptance of New Drug Registration Dossiers and Temporary Suspension of Issuance of Registration Numbers for Circulation for Submitted Dossiersừng 1. The Ministry of Health will suspend acceptance of new drug registration dossiers and temporarily suspend issuance of registration numbers for circulation for submitted dossiers in the following cases:
a) The registration entity and/or the production facility has two or more drugs suspended from circulation within one year;
b) The registration entity and/or the production facility has drugs withdrawn due to violation of any of the provisions stipulated in Clauses 1, 5, and 6 of Article 33 of this Circular; or falls under the case stipulated in Clause 4 of Article 33 of this Circular without notifying the Ministry of Health;
c) The registration entity and/or the production facility violates any of the prohibited acts stipulated in Article 3 of this Circular; d) The registration entity and/or the production facility provides dossiers, data, and information related to technical dossiers including quality standard dossiers, production methods, stability based on research, experimentation, or actual production of the production facility or the registration entity; e) The registration entity and/or the production facility submits drug samples for registration not researched or produced as stated in the production registration dossier.
2. The registration entity and/or the production facility falling under the case stipulated at point c, Clause 1 of this Article is also subject to criminal or administrative penalties according to current relevant laws.
Article 35. Authority to Issue Decisions, Responsibility to Notify, and Time Limit for Withdrawal of Registration Numbers for Circulation, Suspension of Acceptance of Dossiers, and Temporary Suspension of Issuance of Registration Numbers for Circulationo 1. The Minister of Health delegates the Director of the Drug Administration Department to issue decisions to withdraw registration numbers for circulation, suspend acceptance of dossiers, and temporarily suspend issuance of registration numbers nationwide.of educational institutions, 2. Provincial Departments of Health, Municipal Departments of Health under the Central Government, and Health Departments of sectors notify decisions to withdraw registration numbers, suspend acceptance of dossiers, and temporarily suspend issuance of registration numbers within their jurisdiction.of educational institutions, 3. The maximum time limit for suspending acceptance of new drug registration dossiers and temporarily suspending issuance of registration numbers for circulation for submitted dossiers for cases stipulated at point a, b, c, Clause 1 of Article 34 of this Circular is two years from the date of signing the Decision to withdraw the registration number or suspend circulation of the second drug or the decision to handle violations by the competent state management agency with authority against the entity committing the violation stipulated at point c, Clause 1 of Article 34 of this Circular.
4. The maximum time limit for suspending acceptance of new drug registration dossiers and temporarily suspending issuance of registration numbers for circulation for submitted dossiers for cases stipulated at point d, đ, e, Clause 1 of Article 34 of this Circular is one year from the date of the final notification of the violation of the relevant regulations by the registration entity.
ORGANIZATION AND ACTIVITIES OF REVIEW EXPERTS AND ADVISORY BOARDS FOR ISSUANCE OF REGISTRATION NUMBERS FOR DRUG CIRCULATIONof educational institutions, nghiên cứu hoặc sản xuất được ghi trong hồ sơ đăng ký sản xuất.
2. Cơ sở đăng ký và/hoặc cơ sở sản xuất thuốc thuộc trường hợp quy định tại điểm c khoản 1 Điều này còn bị xử lý hình sự, hành chính theo quy định của pháp luật hiện hành có liên quan.
Article 35. Competence to issue decisions, responsibility to notify and time limit for withdrawing registration numbers, suspending acceptance of new applications, and suspending issuance of registration numbers for drugs
1. The Minister of Health authorizes the Director of the Drug Administration Department to issue decisions to withdraw registration numbers, suspend acceptance of new applications, and suspend issuance of registration numbers nationwide.
2. Provincial Departments of Health under centrally governed cities and health departments of sectors shall notify decisions to withdraw registration numbers, suspend acceptance of new applications, and suspend issuance of registration numbers within their respective jurisdictions.
3. The time limit for suspending acceptance of new drug registration applications and suspending issuance of registration numbersừng for drug registration numbers for submitted applications for cases specified in points a, b, and c of Clause 1 of Article 34 of this Circular is a maximum of two years from the date of signing the Decision to withdraw registration numbers or suspend circulation of the second drug or having a decision by a competent state management agency regarding the violation of point c of Clause 1 of Article 34 of this Circular by the entity committing the violation.
4. The time limit for suspending acceptance of new drug registration applications and suspending issuance of registration numbersừng for drug registration numbers for submitted applications for cases specified in points d, đ, and e of Clause 1 of Article 34 of this Circular is a maximum of one year from the date of the final notification document regarding the violation of the relevant regulations by the entity registering and circulating the drug.
Chapter V
ORGANIZATION AND OPERATIONS OF REVIEW EXPERTS AND ADVISORY BOARDS FOR ISSUING DRUG REGISTRATION NUMBERS
Article 36. Organization and activities of the Drug Registration Number Advisory Council
1. The Ministry of Health shall establish the Drug Registration Number Advisory Council (hereinafter referred to as the Advisory Council).
2. The Advisory Council shall have the task of advising the Ministry of Health on issuing registration numbers for drugs circulating in Vietnam; policies regarding harmonization of drug registration regulations with countries in the region and worldwide; production, importation, and circulation policies for drugs in Vietnam, including the use of drugs on Vietnamese people to assess their safety and efficacy when necessary.
3. The Advisory Council shall operate under the principle that advisory opinions of the Advisory Council must be based on legal grounds, scientific foundations, and must be reflected in the minutes of the Advisory Council meetings. The Advisory Council shall be responsible to the Minister of Health for all advisory opinions related to drug registration.
4. The Drug Administration shall be responsible for advising the Minister of Health on the issuance of regulations concerning the organization and operation of the Advisory Council, and the coordination mechanism between the Advisory Council and expert groups during the process of issuing registration numbers for circulating drugs.
Article 37. Organization and activities of expert groups reviewing drug registration files
1. The Ministry of Health shall assign the Drug Administration the responsibility to establish expert groups reviewing drug registration files (hereinafter referred to as expert review groups).
2. The expert review groups shall advise the Drug Administration on reviewing drug registration applications and recommending issuance, supplementation, or denial of drug registration numbers.
3. Expert review groups shall operate under the principle that advisory opinions and/or recommendations of expert reviewers must be based on legal grounds, scientific foundations, and must be reflected in the minutes of the drug registration file reviews. Expert reviewers shall be responsible to the Director of the Drug Administration for all advisory contents/opinions and recommendations related to the review of drug registration files.
4. The Drug Administration shall develop and issue regulations on criteria for selecting, organizing, and operating expert review groups for drug registration files; sign annual contracts with expert reviewers; organize reviews, compile review results to submit to the Advisory Council; organize training courses for expert reviewers; conduct evaluations of professional capacity and compliance with regulations to adjust and supplement expert reviewers as appropriate.
Chapter VI
IMPLEMENTATION
Article 38. Effective date:
This Circular shall take effect six (06) months from the date of issuance.
2. Repeal Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 of the Minister of Health promulgating the Drug Registration Regulations, Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 of the Minister of Health promulgating the Vaccine and Medical Product Registration Regulations, and Decision No. 3947/2004/QĐ-BYT dated November 8, 2004 of the Minister of Health amending and supplementing the "Vaccine and Medical Product Registration Regulations".
Article 39. Transitional Provisions
Drug registration files submitted before the effective date of this Circular shall be reviewed and issued registration numbers according to the Drug Registration Regulations promulgated together with Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 and the Vaccine and Medical Product Registration Regulations promulgated together with Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 of the Minister of Health.
Article 40. Implementation timeline for the Drug Registration Circular
1. From the effective date of this Circular, drug registration entities must submit registration files in accordance with the provisions of this Circular.
2. Before January 1, 2012, for the Quality File portion of re-registered drugs, if the entity cannot prepare the file according to the ACTD model and ASEAN technical guidance accompanying this Circular, the drug registration entity may submit the standard and testing method file as originally registered according to the Drug Registration Regulations promulgated together with Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 and the Vaccine and Medical Product Registration Regulations promulgated together with Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 of the Minister of Health.
3. Requirements for the stability study file of drugs under actual conditions (for new drugs, first-time registered drugs) according to ASEAN guidance shall be uniformly applied from January 1, 2011.
4. The Ministry of Health encourages drug registration entities to submit registration files in accordance with this Circular before its effective date..
Article 41. Responsibility for Implementation
1. The Drug Administration Department shall be responsible for:
a) Organize and implement the provisions of this Circular;
b) Edit and update the Common ASEAN Technical Data (ACTD) file and accompanying technical guidelines for relevant parties to implement;
c) Regularly update the list of drugs registered for circulation by the Ministry of Health (by batches) on the Drug Administration's website;
d) Develop and issue standard operating procedures (SOPs), drug registration guidebooks (QM), and implement them;
đ) Gradually post on the Drug Administration's website information related to drug registration as follows:
- Aggregate data on drugs still valid after being granted registration numbers;
- List of active ingredients still under patent protection;
- Drug labels and approved drug usage instructions;
- List of drug registration and/or manufacturing entities violating the provisions of this Circular;
e) Annually, based on the actual situation of drug registration for circulation, the Drug Administration shall propose appropriate management measures to regulate drug circulation registration in accordance with Vietnamese law and international practices.
2. Provincial and centrally-administered city health departments, Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, foreign companies with permits to operate in the pharmaceutical sector shall be responsible for implementing this Circular.
3. During implementation, if there are any issues, organizations and individuals are requested to promptly report to the Ministry of Health (Drug Administration) for consideration and resolution./.
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