Circular No. 44/2014/TT-BYT on drug registration

CIRCULAR

Regulations on drug registration

_____________

 

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Drug Administration Department and the Director of the Medical Equipment and Health Works Department,

The Minister of Health issues this Circular to regulate drug registration.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates the registration of drugs for human use circulating in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Chemical drugs are drugs containing active ingredients with defined composition, formula, and purity.

2. New active ingredient is an active ingredient that appears for the first time in a drug registration for circulation in Vietnam.

3. Generic drug is a finished product manufactured without a license from the company holding the original drug patent and marketed to replace an original drug after the patent or other exclusive rights have expired.

4. Licensed production drug is a drug produced by a domestic or foreign establishment that has been granted a registration number for circulation in Vietnam or abroad, which transfers the right to produce to another establishment in Vietnam that meets the conditions for drug production.

5. Trade name of a drug is a name different from the generic name or international nonproprietary name.

6. ASEAN Common Technical Document (ACTD) is a set of documents guiding the drug registration dossier meeting the common technical requirements of the Association of Southeast Asian Nations (ASEAN), as specified in Appendix I of the ASEAN Common Technical Document and technical guidelines issued together with this Circular.

7. Major change refers to changes significantly affecting the quality, safety, and efficacy of the drug, as defined in Appendix II on major changes, minor changes, and other changes applicable to drugs already registered, issued together with this Circular.

8. Minor change refers to changes that do not affect or affect very little the efficacy, quality, and safety of the drug, as defined in Appendix II on major changes, minor changes, and other changes applicable to drugs already registered, issued together with this Circular.

9. Other change refers to changes that do not fall under major changes or minor changes as defined in Appendix II on major changes, minor changes, and other changes applicable to drugs already registered, issued together with this Circular.

10. Drug 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 registered.

11. Drug manufacturing entity is the entity performing at least one production process or conducting quality control before releasing a batch of drugs.

Article 3. Requirements, rights, and responsibilities of the drug registration entity

1. The drug registration entity must meet the following requirements:

a) Possess a Certificate of Eligibility for Pharmaceutical Business in Vietnam if it is a Vietnamese pharmaceutical business entity.

b) Possess a Production and Business License issued by the competent authority of a foreign country and a Representative Office Establishment Permit in Vietnam if it is a foreign pharmaceutical business entity. In cases where there is no Representative Office Establishment Permit in Vietnam, the foreign pharmaceutical business entity must authorize a Vietnamese pharmaceutical business entity to register the drug.

2. The drug registration entity has the following rights:

a) To be guided on drug registration and to know information related to the drug submitted by the named entity;

b) To request withdrawal of the registration number of the drug submitted by the named entity according to Form No. 01/TT issued together with this Circular;

c) To appeal administrative decisions of the competent state management authority related to the issuance of the drug circulation registration number according to the law on appeals.

3. The drug registration entity has the following responsibilities:

a) To ensure the quality, safety, and efficacy of the drug and to ensure that the drug circulates in accordance with the registration dossier;

b) To provide all relevant data, reports, and information about the drug when submitting the registration dossier, during the registration process, as well as during the drug circulation period or upon request of the competent state management authority;

c) To update information related to the quality, safety, and efficacy of the drug when such information is not included in the submitted dossier or during the dossier review process; changes to the drug in circulation compared to the registration dossier during the validity period of the registration number, including changes that do not fall under the categories of changes requiring registration as specified in Appendix II issued together with this Circular;

d) Within a maximum of seven working days, to notify the Drug Administration Department or the Medical Equipment and Health Works Department (for in vitro diagnostic products) and other relevant state management authorities in case the drug with a valid registration number for circulation in Vietnam has its circulation permit revoked in any country worldwide, clearly stating the reason for revoking the circulation permit;

đ) To cooperate with importers and manufacturers to recall from the market drugs that do not meet quality, safety, and efficacy standards as required by the state management authority or discovered by the registration entity or manufacturer; to report the results of the recall and propose handling measures;

e) To submit a written report by December 15 each year to the Drug Administration Department or the Medical Equipment and Health Works Department (for in vitro diagnostic products) on the types of registered drugs that are circulating; to explain the reasons for cases where registered drugs are not produced (for domestic drugs) or imported (for foreign drugs) according to Form No. 02/TT issued together with this Circular;

g) To retain complete dossiers and provide them to the competent state management authority upon request;

h) To cooperate and facilitate inspections and evaluations of production facilities upon notification by the Drug Administration Department or the Medical Equipment and Health Works Department (for in vitro diagnostic products);

i) To change the registration entity for drugs registered by the named entity according to the provisions in Appendix II issued together with this Circular within a maximum of one month from the date the registration entity ceases operations or is terminated by the competent state management authority.

k) Cooperate with the manufacturer to conduct studies or provide additional information related to the registered drug when there is suspicion or evidence concerning the safety of the drug during circulation, as required by the competent state management agency.

Article 4. Requirements, rights, and responsibilities for pharmaceutical production facilities

1. Pharmaceutical production facilities must meet the following requirements:

a) Domestic pharmaceutical production facilities must have a Business Registration Certificate for Medicines and a Good Manufacturing Practice (GMP) Certification according to the Ministry of Health's GMP implementation roadmap, or a Business Registration Certificate for Medicines for cases where the production facility must be assessed for production conditions when issuing the Business Registration Certificate for Medicines as stipulated in Clause 8, Article 1 of Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government amending and supplementing some articles of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law.

b) Foreign pharmaceutical production facilities must meet equivalent or higher Good Manufacturing Practice (GMP) standards based on the World Health Organization's (WHO) Good Manufacturing Practice guidelines. In cases where the GMP Certification or Product Certification (CPP) does not clearly indicate that the production facility meets WHO GMP principles and standards, the registration entity must provide evidence proving that the GMP principles and standards achieved by the production facility are not lower than WHO GMP principles and standards. For in vitro diagnostic products, the production facility must meet GMP, ISO, or other equivalent certifications. In cases of doubt regarding production conditions or drug quality, the Drug Administration or the Department of Medical Equipment and Health Works (for in vitro diagnostic products) will conduct an inspection of the production facility before or after granting the registration number for circulation.

c) Drugs must be produced at the correct production facility licensed by the competent state authority, and shall not be produced at other facilities under a loaned production license (Loan Licence).

2. Pharmaceutical production facilities have the following rights:

a) To be guided on drug registration and to be informed of information related to drugs registered in Vietnam by their production facilities;

b) To request withdrawal of the registration number of drugs produced by their facilities in cases where the drugs have quality, safety, and efficacy issues affecting user health without necessarily requiring the consent of the drug registration entity according to Form No. 01/TT issued together with this Circular;

c) To appeal administrative decisions of the competent state authority related to the issuance of drug circulation registration numbers in accordance with the law on appeals;

d) To request a change to another registration entity for drugs of their own production facilities in cases where the registration entity fails to comply with point i, clause 3, Article 3 of this Circular;

3. Pharmaceutical production facilities have the following responsibilities:

a) To ensure that drugs meet the quality, safety, and efficacy standards specified in the registration dossier approved by the Ministry of Health;

b) To cooperate with import facilities and drug registration entities to recall from the market drugs that do not meet quality, safety, and efficacy standards upon the requirement of the competent state management authority or due to discovery by the drug registration entity or production facility itself; report the results of the recall and propose handling measures;

c) To cooperate with drug registration entities to implement the contents prescribed in points d, h, and k, clause 3, Article 3 of this Circular;

d) To prepare all necessary means and working conditions to serve inspections and evaluations of the production facility when requested by the Drug Administration or the Department of Medical Equipment and Health Works (for in vitro diagnostic products).

Article 5. Requirements for franchising bases and franchisees producing drugs, drugs produced under contract manufacturing

1. For chemical drugs, vaccines, serum containing antibodies, medical products: franchising bases and franchisees producing must meet GMP-WHO standards or higher; for in vitro diagnostic products: must meet GMP, ISO or equivalent standards.

2. For traditional medicine drugs, drugs from medicinal materials, raw materials for drug production:

a) Overseas franchising bases must meet GMP-WHO standards or higher. Domestic franchising bases shall implement the roadmap for applying GMP as prescribed 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 set forth in Circular No. 23/2013/TT-BYT dated August 13, 2013 of the Minister of Health guiding contract manufacturing activities shall be followed.

Article 6. Requirements for drug testing certificates in registration files

1. For chemical drugs, medical products, traditional medicine drugs, drugs from medicinal materials

a) Drug production bases that meet GMP standards shall self-assess the standards, conduct testing, and submit their own testing certificates to file the registration application.

b) In cases where domestic drug production bases have not yet met GMP standards, the drug registration base must conduct standard assessment and submit a testing certificate from one of the State central drug testing facilities or a drug testing service enterprise with a business license for drug trading.

2. For vaccines, serum containing antibodies, in vitro diagnostic products

a) Vaccine and serum containing antibody registration bases must conduct standard assessment and submit testing certificates from the National Institute of Vaccines and Medical Products Quality Control.

b) Registration bases for in vitro diagnostic products may submit their own testing certificates if the production base meets GMP standards or equivalent standards. In cases where the production base has not met GMP or ISO standards or equivalent standards, the registration base must conduct standard assessment and submit testing certificates from the National Institute of Vaccines and Medical Products Quality Control.

3. During the review of drug registration files, the drug registration base must re-evaluate the standards and testing methods at testing facilities designated by the Ministry of Health for the cases specified in Appendix III issued together with this Circular.

Article 7. Requirements for drug safety and efficacy

1. New drugs when registering for circulation in Vietnam must conduct clinical trials as stipulated in Circular No. 03/2012/TT-BYT dated February 2, 2012 of the Minister of Health guiding clinical drug trials.

2. Drugs granted circulation registration numbers for the first time but require monitoring and evaluation of safety and efficacy during circulation, the registration base and healthcare facilities using the drugs must report on drug safety and efficacy when resubmitting the registration file according to the following requirements:

a) The registration base, in collaboration with the production base (if the registration base is not the production base), is responsible for reporting on drug safety and efficacy according to Form No. 03A/TT issued together with this Circular and sending it to the Ministry of Health (Drug Administration Department or Medical Equipment and Construction Department for in vitro diagnostic products) and implementing the storage of related files and documents for drug safety and efficacy reports.

b) Healthcare facilities using drugs requiring monitoring and evaluation of safety and efficacy are responsible for reporting on drug usage according to Form No. 03B/TT issued together with this Circular and sending it to the Ministry of Health (Drug Administration Department or Medical Equipment and Construction Department for in vitro diagnostic products); implementing the storage of related files and documents for drug usage reports to serve inspection and evaluation of drug effectiveness and safety.

Article 8. Requirements for Bioavailability and Bioequivalence of Drugs

The submission of research data reports on bioavailability and bioequivalence of drugs for registration shall be carried out in accordance with the provisions on the submission of research data reports on bioavailability and bioequivalence as stipulated in Circular No. 08/2010/TT-BYT dated April 26, 2010, issued by the Minister of Health guiding the reporting of research data on bioavailability and bioequivalence in drug registration.

Article 9. Forms of Drug Registration

Chemical drugs, medical biological products, vaccines, antibody-containing sera, in vitro diagnostic biological products, traditional medicine drugs, herbal drugs, and drug raw materials shall be registered in the following forms:

1. Initial registration applies to drugs in one of the following cases:

a) Drugs that have not been granted a registration number in Vietnam;

b) Drugs that have been granted a registration number in Vietnam and within the validity period of the registration number, there are changes as specified in Appendix II attached to this Circular, or when the registration number expires, initial registration must be requested;

c) Drugs that have been granted a registration number in Vietnam but did not submit the application dossier within the prescribed time limit for re-registration or extension registration as stipulated in Clause 2, Article 12 of this Circular when the registration number expires.

2. Re-registration applies to drugs that have been granted a registration number but the registration number has expired and do not meet the conditions for extension registration as stipulated in Clause 3 of this Article.

3. Extension registration applies to drugs that have been granted an initial registration or re-registration but have expired and meet the following requirements:

a) Chemical drugs, traditional medicine drugs, herbal drugs, and drug raw materials:

- Have been granted a valid registration number for five years at the time of initial registration or re-registration and have been marketed after being granted the registration number.

- The initial registration dossier or re-registration dossier has been completed according to the ACTD or ICH-CTD model and ASEAN technical guidance for chemical drugs or in accordance with Circular No. 22/2009/TT-BYT dated September 24, 2009, issued by the Minister of Health regarding drug registration for traditional medicine drugs, herbal drugs, and drug raw materials (the initial registration dossier submitted after May 24, 2010, or the re-registration dossier submitted after January 1, 2012).

- Not falling under any of the cases specified in Articles 32 and 33 of this Circular.

- There is no recommendation from the World Health Organization or the Vietnamese or foreign drug regulatory authority regarding treatment efficacy during the extension registration period.

- There is no change or addition at the time of submitting the extension registration dossier and during the review process of the extension registration dossier.

b) Vaccines, medical biological products, antibody-containing sera, in vitro diagnostic biological products:

- Have been granted a valid registration number for five years at the time of initial registration or re-registration and have been marketed after being granted the registration number;

- The initial registration dossier or re-registration dossier has been completed in accordance with Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Minister of Health regarding drug registration (the initial registration dossier submitted after May 24, 2010, or the re-registration dossier submitted after January 1, 2012).

- Not falling under any of the cases specified in Articles 32 and 33 of this Circular;

- There is no recommendation from the World Health Organization or the Vietnamese or foreign drug regulatory authority regarding treatment efficacy or use during the extension registration period;

- There is no change or addition at the time of submitting the extension registration dossier and during the review process of the extension registration dossier.

c) A drug may be considered for multiple extensions if it fully meets the requirements specified in point a or b of this clause.

4. Change and Supplement Registration applies to a drug that already has a registration number but undergoes changes or supplements during the validity period of the registration number as specified in Appendix II attached to this Circular.

When there are changes or supplements made according to the requirements of the Advisory Committee for Granting Registration Numbers, the registering entity coordinates with the manufacturing entity to update and supplement in accordance with the guidance of the competent state management agency and bears responsibility for the changed content without having to submit a change registration dossier.

Article 10. Naming of Medicines

1. The Ministry of Health encourages registration entities to use international non-proprietary names (INN) for medicine names.

2. In cases where medicines are not named according to INN, the registration entity may use trade names for medicines. Trade names of medicines must comply with the following principles:

a) Not overstating the therapeutic effects of the medicine;

b) Not misstating the therapeutic effects and pharmacological actions of the medicine;

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;

e) Not using the same name for medicines with different active ingredients;

g) Not using different names for medicines with the same formulation and production process from the same manufacturer.

Article 11. Language, Form of Application, Sample Medicine, and Fees

1. Languages used in the application dossier:

a) Application dossiers for domestically produced medicines must be written in Vietnamese;

b) Application dossiers for imported medicines must be written in Vietnamese or English. In cases where they are written in English, information in the Instructions for Use and Summary of Product Characteristics must be translated into Vietnamese.

2. Application dossiers for medicines must be prepared on A4 paper size, securely bound. The dossiers must be arranged in accordance with the table of contents, with clear divisions between sections. Each section must be numbered for easy reference and must have confirmation from the registration entity or the medicine manufacturer at the beginning of each section throughout 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 application, re-registration, extension registration, and change registration are as follows:

a) One original copy of the complete dossier as prescribed in Clause 1 and 2 of Article 16 of this Circular for chemical drugs, vaccines, serum containing antibodies, medical products (excluding in vitro diagnostic products), Clause 1 and 2 of Article 21 of this Circular for in vitro diagnostic products, and Clause 1 and 2 of Article 25 of this Circular for traditional medicine, Chinese medicine, and raw materials for medicine;

b) Two copies of the documents including the drug registration form and finished product standards; additionally, for vaccines, serum containing antibodies, and medical products (excluding in vitro diagnostic products), one full original dossier copy must be provided;

c) Medicine labels: two sets of label design samples. These labels must be attached to A4 paper stamped by the registration entity or the manufacturer. When re-registering, there is no need to resubmit the labels if there are no changes compared to the initial registration;

d) Product information: Instructions for Use suitable for each type of medicine as stipulated in Circular No. 04/2008/TT-BYT dated May 12, 2008, issued by the Minister of Health on labeling of medicines, stamped by the registration entity or the manufacturer. When re-registering, there is no need to resubmit product information if there are no changes compared to the initial registration;

đ) Medicine samples, raw materials for medicine:

- One unit of packaging for each registration specification;

- Sufficient quantity for three testing cycles for raw materials;

- For vaccines, serum containing antibodies, the registration entity shall send samples for storage at the National Institute of Vaccines and Medical Products;

5. For change and supplementary registration dossiers: one original copy of the complete documents as required by the content of major or minor changes as stipulated in Clause 5 and Clause 6 of Article 16 of this Circular for chemical drugs, vaccines, serum containing antibodies, medical products, Clause 3 and Clause 5 of Article 21 of this Circular for in vitro diagnostic products, and Clause 3 and Clause 4 of Article 25 of this Circular for traditional medicine, Chinese medicine, and raw materials for medicine.

6. Legal document requirements:

a) Certificate of Pharmaceutical Product (CPP), Production and Business License for Drugs issued by foreign competent authorities, Good Manufacturing Practice (GMP) certificate, establishment permit for Representative Office in Vietnam, or certificates of equivalent standards for in vitro diagnostic products may be submitted in original, copy, or Vietnamese translation from foreign language but must comply with specific regulations for each type of certificate as stipulated in Point b, c, or d of this clause and general regulations as follows:

- In case of submitting original: The original must contain full signatures, names, positions of the signatories, and stamps of the competent authority issuing the certificate; it must be legalized by the diplomatic mission of Vietnam according to the provisions of the law on legalization of foreign public documents, except in cases where the legal documents are issued by the competent authorities of those countries which have signed mutual legal assistance treaties with Vietnam.

- In case of submitting copies: Copies must be certified as true copies by the competent Vietnamese authority according to the provisions of Vietnamese law on certification of true copies from originals or copies issued from original records. In necessary cases, the original must be presented for comparison.

- In case of submitting Vietnamese translations from foreign languages: The Vietnamese translation must be notarized according to the regulations (here, notarization means that the signature of the translator must be certified by a local notary office or diplomatic mission, consulate, or other authorized body of the foreign country, and the translator must commit to translating accurately according to the original as stipulated by law) and must be accompanied by the original or certified copy of the certificate as stipulated above.

- The validity period of the permit or certificate: The validity period must be clearly stated on the certificates and must still be valid at the time of assessment; extension letters for these certificates will not be accepted. If this certificate does not specify the validity period, only certificates issued within 24 months from the date of issuance will be accepted.

b) The Certificate of Pharmaceutical Product (CPP), in addition to complying with the provisions set out in point a of this clause, must also comply with the following provisions:

- Issued by the competent drug regulatory authority (listed on the WHO website at http://www.who.int); issued according to the World Health Organization (WHO) model applicable to the Quality Certification System for pharmaceutical products circulating in international trade.

- Confirmed that the medicine is permitted to circulate in the country of manufacture. In cases where the medicine is not authorized to circulate in the country of manufacture or is authorized but the medicine is not actually circulating in the country of manufacture, the registering entity must provide a CPP certificate confirmed that the medicine is circulating in one of the reference countries including: the United Kingdom, France, Germany, Australia, Canada, or countries in the region covered by the International Conference on Harmonisation (ICH) agreement.

c) The production and business permit for medicines issued by foreign competent authorities, in addition to complying with the provisions set out in items (i), (ii), and (iii) of point a of this clause, must also include the following contents:

- Name and address of the competent authority issuing the permit.

- Name and address of the medicinal product business establishment.

- Scope of operation.

- Validity period of the Permit and the remaining validity period must be at least 24 months at the time of assessment. In cases where there is no specified validity period, the foreign medicinal product business establishment must provide a certificate from the issuing authority confirming that the establishment is still operating in the pharmaceutical field, and only certificates issued within 24 months from the date of issuance will be accepted.

d) Certificates of compliance with Good Manufacturing Practice (GMP-WHO) standards (not applicable to domestic manufacturing establishments), ISO, or equivalent certificates must be issued by the competent authority in the country of manufacture, and must confirm the name and address of the manufacturer.

đ) The business registration certificate of the registering entity may be a certified copy or a self-certified copy (in cases where the registering entity is different from the manufacturing entity).

e) Certificates, intellectual property protection documents, and contracts transferring ownership rights related to the application for registration of medicines (if any) issued by competent authorities for intellectual property rights must be certified copies or copies stamped by the registering entity.

7. 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) Power of attorney forms according to Form No. 05/TT issued together with this Circular must be submitted in the following cases:

- Power of attorney named after the registering entity according to Form No. 5A issued together with this Circular;

- Power of attorney for signing the application form when the registering entity authorizes its representative office in Vietnam according to Form No. 5B issued together with this Circular;

- Power of attorney for using the name of the medicine to register as a trademark when the owner of the trademark is not the registering entity according to Form No. 5C issued together with this Circular.

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) Certified copy of the franchise contract for medicines produced under a franchise arrangement.

8. Medicine labels and product information:

The content of the medicine label and product information shall be implemented in accordance with the provisions of Circular No. 04/2008/TT-BYT dated May 12, 2008, guiding the labeling of medicines issued by the Minister of Health.

9. Medicines registration fees:

The registering entity must pay fees related to the registration and circulation of medicines, and GMP inspection and supervision of the manufacturing establishment in accordance with current laws on fees and charges.

Article 12. Effectiveness of drug registration numbers and deadlines for submitting renewal and extension registration applications

1. The maximum validity period of a drug circulation registration number is five (5) years from the date of issuance of the Decision granting the registration number or extending the registration number. In cases where the Drug Registration Number Granting Advisory Council of the Ministry of Health requests further safety and efficacy assessments of the drug, the maximum validity period of the registration number is three (3) years from the date of issuance of the Decision granting the registration number.

2. Deadlines for submitting renewal and extension registration applications:

a) Within six (6) months before the expiration of the validity period of the drug circulation registration number, the registrant may submit an application for extending the registration number. Where the Drug Administration issues a notice regarding applications that do not meet the conditions for extending the registration number as stipulated in Clause 3, Article 9 of this Circular, the registrant may submit a new registration application in accordance with the regulations and have it reviewed immediately upon submission.

b) Within twelve (12) months prior to and six (6) months following the expiration of the validity period of the drug circulation registration number, the registrant may submit a new registration application. If the registrant has already submitted a new registration application, they shall not be allowed to submit an extension registration application.

Chapter II

INTELLECTUAL PROPERTY RIGHTS FOR REGISTERED DRUGS

Article 13. General Principles

1. The registrant bears responsibility for intellectual property rights concerning registered drugs in circulation.

2. Registrants must establish intellectual property rights or conduct searches on related intellectual property objects before registering drugs for circulation in Vietnam.

3. In cases of intellectual property disputes during the review process for granting registration numbers, the party opposing the grant of the registration number due to intellectual property disputes must provide conclusions from the competent state management agency on intellectual property rights or the enforcement agency regarding acts of infringing intellectual property rights. The Ministry of Health will not grant a registration number for circulation if there is sufficient basis to determine that the drug, when granted a registration number for circulation, will infringe upon the intellectual property rights of other individuals or organizations.

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 according to the judgment of the Court or the final conclusion of the competent state management agency on intellectual property rights or the enforcement agency regarding acts of infringing intellectual property rights, the Ministry of Health will decide to withdraw the registration number or suspend circulation in accordance with Clause 6, Article 32 or Clause 2, Article 33 of this Circular.

Article 14. Patents Related to Registered Drugs

1. For drugs containing active ingredients still under intellectual property protection, the registrant may provide relevant legal documents concerning the status of protection and intellectual property rights (patent certificates) for the registered drug (if applicable).

2. Within two (2) years before a drug's patent protection expires, the registrant may submit an application for the circulation of a generic drug along with documentation proving that the protected drug's patent is about to expire and must clearly indicate the request in the application form according to Form 6A/TT issued together with this Circular.

Article 15. Data Confidentiality for Registration Files

If a drug registration entity requires data confidentiality for new drug registration files in accordance with the provisions on data confidentiality for drug registration files as stipulated in Circular No. 05/2010/TT-BYT dated March 1, 2010, issued by the Minister of Health to guide data confidentiality in drug registration, it must clearly state this request in the application form according to Model 6A/TT attached to this Circular.

Chapter III

DRUG REGISTRATION FILE

Section 1

DRUG REGISTRATION FILE FOR NEW CHEMICAL DRUGS, VACCINES,

ANTISERUM CONTAINING ANTIBODIES, MEDICAL BIOPRODUCTS

Article 16. 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 File and Product Information;

b) Part II. Quality File: In cases where the initial registration file was prepared according to the ASEAN Common Technical Document (ACTD) or the International Conference on Harmonisation Common Technical Document (ICH-CTD) model and meets the common technical requirements of ASEAN, resubmission only requires submission of finished product standards and testing methods.

4. Renewal registration file includes:

a) Part I. Administrative File and Product Information;

b) Part II. Other Files Including:

- Copies of letters from the Drug Administration Department or the Medical Equipment and Infrastructure Department permitting changes or additions during circulation, copies of files and documents that have been implemented through notification-only procedures;

- Copies of finished product standards and testing methods for drugs not following pharmacopoeia standards;

- Files and documents proving the importation of foreign drugs into Vietnam for imported drugs. Files and documents proving the production and distribution of domestic drugs in Vietnam for domestically produced drugs.

5. Registration file for major changes:

a) Part I. Administrative File and Product Information;

b) Part II. Quality File;

c) Part IV. Clinical File;

Major changes and corresponding files to be submitted shall be carried out in accordance with the guidance provided in Appendix II of this Circular.

6. Registration file for minor changes:

a) Part I. Administrative File and Product Information;

b) Part II. Quality File;

Minor changes and corresponding files to be submitted shall be carried out in accordance with the guidance provided in Appendix II attached to this Circular.

7. Registration file for other changes: The files to be submitted shall comply with the provisions of Clause 1 of this Article.

8. The files specified in Clauses 1, 2, 3, 4, and Clause 5 of this Article must be implemented in accordance with the following provisions:

a) Apply the provisions set forth in Appendix I attached to this Circular, including:

- ASEAN Common Technical Document (ACTD);

- Research Stability Guidance;

- Production Process Review Guidance;

- Analytical Method Validation Guidance;

- Bioavailability and Bioequivalence Study Guidance;

b) Layout according to the ACTD model. For new chemical drugs, vaccines, antisera containing antibodies, medical bioproducts that cannot be arranged according to the ACTD, they may be laid out according to the International Conference on Harmonisation Common Technical Document (ICH-CTD).

9. For manufactured drugs, the requirements for the files to be submitted shall be carried out in accordance with the provisions of Circular No. 23/2013/TT-BYT dated August 13, 2013, issued by the Minister of Health guiding the operation of drug manufacturing.

Article 17. Administrative files and product information

Administrative files and product information include:

1. Table of contents;

2. Post-marketing safety and efficacy report according to Form No. 03/TT issued together with this Circular for drugs requiring evaluation of safety and efficacy at the time of initial registration;

3. Product summary according to Form No. 04/TT issued together with this Circular;

4. Power of attorney (if any) according to Form No. 05/TT issued together with this Circular;;

5. Registration application form according to Form No. 06/TT issued together with this Circular;

6. Cover page according to Form No. 07/TT issued together with this Circular;

7. Drug post-marketing circulation report for re-registration applications according to Form No. 08/TT issued together with this Circular;

8. Summary of drug registration history for extension registration applications according to Form No. 09/TT issued together with this Circular;

9. Certificate of qualification for pharmaceutical business if it is a Vietnamese pharmaceutical business entity and only needs to be submitted once for all drugs within the validity period of the License;

10. Production and business license for foreign drug registration entities issued by competent authorities of foreign countries and only needs to be submitted once for all drug registration applications within the validity period of the License;

11. Certificate of Current Good Manufacturing Practice (CPP) according to Form No. 01/ACTD issued together with this Circular for foreign drugs;

12. Certificate of Good Manufacturing Practice (GMP) of the foreign drug manufacturing facility if the CPP does not confirm that the production facility meets GMP standards. In cases where multiple facilities participate in the drug production process, the drug registration entity must submit GMP certificates from all participating production facilities involved in producing the finished product;

13. Drug label, only a copy of the approved drug label is required for extension registration applications;

14. Product information: drug usage instructions according to the Circular guiding drug labeling requirements, only a copy is required for extension registration applications;

15. Product characteristics summary for new chemical drugs, vaccines, sera containing antibodies, and medical products according to Form No. 02/ACTD issued together with this Circular (not required for extension registration applications);

16. Licensing agreement or franchise contract for franchised manufactured drugs. Contract for commissioned manufactured drugs;

17. Certificates, industrial property rights protection documents, and contracts transferring ownership rights related thereto (if any);

18. Other legal documents (if any);

19. Certificate of Good Manufacturing Practice (GMP) of the packaging production facility directly contacting the drug according to Circular No. 14/2012/TT-BYT dated August 31, 2012 of the Minister of Health on principles and standards of "Good Manufacturing Practices for Pharmaceutical Packaging" or equivalent certificate regarding the production conditions of the packaging production facility directly contacting the drug;

Article 18. Quality File

1. The quality file shall be implemented according to the guidance in Part II- ACTD and includes the following documents:

a) Table of contents;

b) Overview of quality;

c) Content and data;

d) Reference materials;

e) Overall production facility file according to Form No. 10/TT issued together with this Circular. In cases where a product is produced through multiple stages, the overall file must be the file of all manufacturers involved in producing the product before it enters the market;

2. The quality file in the drug production registration file under the franchise model must include all the contents prescribed in Clause 1 of this Article. Specifically, the content and data of the quality file shall be carried out as follows:

a) Content and data related to the drug produced before franchising must be performed and provided by the franchisor including:

- Section Active Ingredient (S): General Information (S1); Characteristics (S3) and Active Ingredient Testing (S4), except for the results of testing the quality of batches of active ingredients used in the production of finished product batches at the franchisee's facility for the purpose of registering franchised drug production;

- Section Finished Product (P): Description and Composition (P1); Pharmacological Development (P2); Production (P3), except for section P3.4. Process Review and/or Evaluation; Excipient Testing (P4); Finished Product Testing (P5), except for section Batch Analysis (P5.4); Packaging System (P7);

b) Content and data related to the drug produced under the franchise model must be performed and provided by the franchisee including:

- Section Active Ingredient (S): Production (S2); Reference Standard or Comparative Material (S5); Packaging System (S6) and Stability (S7);

- Section Finished Product (P): Process Review and/or Evaluation (P3.4); Batch Analysis (P5.4); Reference Standard or Comparative Material (P6); Stability (P8) and Interchangeability of Products (P9);

c) In cases where the drug produced under the franchise model differs from the drug produced before franchising in terms of the content and data provided in the file as stipulated in Point b Clause 2 of this Article: The franchisee must fully declare all changes in the Registration Application Form according to Form No. 6Đ issued together with this Circular and provide relevant documents as specified in Appendix II for each corresponding change.

Article 19. Preclinical File

The preclinical file shall be implemented according to the guidelines in Part III- ACTD and includes 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 20. Clinical File

The clinical file shall be implemented according to the guidelines in Part IV- ACTD and includes 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.

Section 2

REGISTRATION FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES

Article 21. Documents to be Submitted

1. Initial registration file for in vitro diagnostic medical devices, including semi-finished products, includes:

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.

3. Registration file for changes includes:

a) Application form (according to the template);

b) Relevant parts of the file related to the change: submit corresponding parts of the file as stipulated in Section A- Appendix IV issued together with this Circular.

4. Renewal registration file includes:

a) Part I. Administrative file;

b) Part II. Other Files Including:

- Copies of letters from the Drug Administration Department or the Medical Equipment and Infrastructure Department permitting changes or additions during circulation, copies of files and documents that have been implemented through notification-only procedures;

- Copy of the quality file as stipulated in Section A- Appendix IV attached to this Circular;

- Documentation proving that the in vitro diagnostic medical device has been imported into Vietnam for foreign drugs. Documentation proving that the in vitro diagnostic medical device has been produced and distributed in Vietnam for domestic drugs.

5. Registration file for other changes must resubmit the initial registration file according to the guidelines in Section B - Appendix IV issued together with this Circular.

Article 22. Administrative File and Product Information

The administrative file includes the following documents:

1. Table of contents;

2. Post-market safety and efficacy report according to Form No. 3/TT issued together with this Circular for drugs requiring evaluation of safety and efficacy when first registering;

3. Product summary according to Form No. 04/TT issued together with this Circular;

4. Power of attorney (if any) according to Form No. 05/TT issued together with this Circular;

5. Registration application form according to Form No. 06/TT issued together with this Circular;

6. Cover page according to Form No. 07/TT issued together with this Circular;

7. Drug post-marketing circulation report for re-registration applications according to Form No. 08/TT issued together with this Circular;

8. Summary of drug registration history for extension registration applications according to Form No. 09/TT issued together with this Circular;

9. Product label (only a copy is required for renewal registration);

10. Production and business license for vaccines and medical products issued by the competent authority of the foreign country for foreign vaccine and medical product registrants or Certificate of Eligibility for Business in Vaccines and Medical Products for domestic vaccine and medical product registrants;

11. Manufacturing country's marketing authorization for foreign products, this provision does not apply to semi-finished products;

12. GMP certificate, ISO certificate, or certificate of equivalent standards from relevant production facilities issued by the competent authority;

13. Intellectual property certificates, economic contracts, and other documents (if any).

Requirements for the file are carried out according to Section A- Appendix IV issued together with this Circular.

Article 23. Quality File

The quality file includes:

1. Table of contents;

2. Active ingredients;

3. Finished products;

4. Stability.

Requirements for the file are carried out according to Section A- Appendix IV issued together with this Circular.

Article 24. Efficacy Evaluation File for In Vitro Diagnostic Medical Devices

The efficacy file for in vitro diagnostic medical devices includes:

1. Table of contents;

2. Research reports.

Requirements for the file are carried out according to Section A- Appendix IV issued together with this Circular.

Section 3

REGISTRATION FILE FOR DRUGS FROM PHARMACEUTICAL SUBSTANCES,

TRADITIONAL MEDICINE AND DRUG RAW MATERIALS

Article 25. Documents 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;

3. Documents for major changes: the contents of major changes and corresponding documents to be submitted shall be carried out in accordance with the guidance set forth in Part I - Section C - Appendix II issued together with this Circular.

4. Documents for minor changes: the contents of minor changes and corresponding documents to be submitted shall be carried out in accordance with the guidance set forth in Part II - Section C - Appendix II issued together with this Circular.

5. Renewal registration documents include:

a) Part I. Administrative File and Product Information;

b) Part II. Other Files Including:

- Copies of letters from the Drug Administration allowing changes and supplements during circulation, copies of documents and materials that have been implemented through notification-only procedures.

- Copies of finished product standards and testing methods for drugs not following pharmacopoeia standards;

- Files and documents proving the importation of foreign drugs into Vietnam for imported drugs. Files and documents proving the production and distribution of domestic drugs in Vietnam for domestically produced drugs.

6. Documents for other changes: Documents to be submitted shall comply with the provisions of Clause 1 of this Article.

Article 26. Administrative documents and product information

Administrative documents and product information shall be carried out in accordance with Article 17 of this Circular.

Article 27. Quality documents

1. Production process:

a) Raw materials:

- For drugs made from medicinal herbs, traditional Chinese medicine: no production process required for excipients and raw materials listed in the pharmacopoeia or produced by another manufacturer. In other cases, a detailed description of the production process of raw materials is required.

- For drug ingredients: a detailed description of the production process is required.

b) Finished products:

- Formula for the smallest packaging unit: name of raw materials including active ingredients and excipients; quantity or concentration of each raw material; standards applied to raw materials; if produced from extract, the corresponding amount of medicinal herbs must be clearly stated;

- 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 drug ingredients listed in the pharmacopoeia, specific details of the pharmacopoeia name and year of publication are required; for drug ingredients not listed in the pharmacopoeia, a detailed description of quality criteria and testing methods is required.

b) Finished products:

- Formula for the smallest packaging unit: Name of raw materials including active ingredients and excipients; Quantity or concentration of each raw material; standards applied to raw materials; if produced from extract, the corresponding amount of medicinal herbs must be clearly stated.

- 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 reports shall be carried out in accordance with Article 6 of this Circular.

đ) Stability research documentation, including:

- Research plan for stability;

- Stability research data;

- Stability study conclusions.

Article 28. Safety and efficacy documents

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 REGULATIONS FOR DRUG REGISTRATION, TEMPORARY SUSPENSION, AND WITHDRAWAL OF REGISTRATION NUMBER

PROCEDURES AND REGULATIONS FOR DRUG REGISTRATION, TEMPORARY SUSPENSION, AND WITHDRAWAL OF REGISTRATION NUMBER

Article 29. Procedures and formalities for receiving and examining drug registration files

1. The Drug Administration Department shall be responsible for:

a) Receiving drug registration files submitted directly or sent via postal service in the following cases:

- Initial drug registration files, re-registration files, extension registration files, except for in vitro diagnostic products registration files and drug registration files for external use produced domestically as specified in Appendix V attached to this Circular.

- Large change, small change, and other change registration files during the validity period of the drug registration number for drugs that have already been assigned a registration number, except for in vitro diagnostic products registration files.

b) Organizing the examination and submitting to the Advisory Council for the issuance of the drug registration number for initial and re-registration files, or submitting to the Minister of Health for approval of the list of drugs for registration number extension for extension registration files received as stipulated in point a, Clause 1, Article 29 of this Circular.

c) Organizing the examination and responding in writing to large change, small change, and other change registration files for drugs that have been assigned a valid registration number as received in accordance with point b, Clause 1, Article 29 of this Circular.

2. The Medical Equipment and Construction Department shall be responsible for:

a) Receiving in vitro diagnostic products registration files submitted directly or sent via postal service for initial, re-registration, extension registration files, and large change, small change, and other change registration files for in vitro diagnostic products that have been assigned a valid registration number;

b) Organizing the examination and submitting to the Advisory Council for the issuance of the drug registration number for initial and re-registration in vitro diagnostic products registration files;

c) Organizing the examination and submitting to the Minister for approval of the list of in vitro diagnostic products for extension registration;

d) Organizing the examination and responding in writing to large change, small change, and other change registration files for in vitro diagnostic products that have been assigned a valid registration number.

3. Provincial/Municipal Health Departments where production facilities are located shall be responsible for:

a) Receiving initial, re-registration, and extension registration files submitted directly or sent via postal service for drugs for external use produced domestically as specified in Appendix V attached to this Circular;

b) Organizing the examination of the files received in accordance with point a of this clause and sending a letter along with the list of drugs that have passed the examination requirements to the Drug Administration Department for issuance of the registration number.

Article 30. 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 examined by the Drug Administration Department as stipulated in point b, Clause 1, Article 29 of this Circular;

b) Drug registration files received and examined by the Provincial/Municipal Health Departments as stipulated in Clause 3, Article 29 of this Circular.

2. The Minister of Health authorizes the Director of the Medical Equipment and Construction Department to issue decisions approving the list of in vitro diagnostic products granted registration numbers for in vitro diagnostic products registration files as stipulated in Clause 2, Article 29 of this Circular.

Article 31. Time limit for issuing registration numbers or responses to applications for major changes, minor changes, and other changes

1. The Drug Administration Department and the Medical Equipment and Health Works Department (for in vitro diagnostic products) shall examine and issue registration numbers for new drug applications and re-registration applications within a maximum period of six months from the date of receipt of complete and valid applications. For renewal applications, this period shall be three months. In cases where applications do not meet the requirements for issuance or renewal of registration numbers, the Ministry of Health shall provide a written response detailing the reasons.

2. Within three months from the date of receiving complete and valid applications, the Health Departments shall organize reviews and send letters along with lists of drugs requesting registration numbers to the Drug Administration Department for those drugs received according to Clause 3, Article 29 of this Circular. If there is insufficient basis to request a registration number, the Health Departments must provide a written response to the applicant detailing the reasons.

3. From the date of receipt of complete and valid applications, the Drug Administration Department and the Medical Equipment and Health Works Department (for in vitro diagnostic products) shall examine and respond to applications for major changes and minor changes within the following maximum periods:

a) Ninety days for major change applications or minor change applications requiring approval before implementation involving two or more proposed changes, and sixty days for minor change applications requiring approval before implementation involving only one change.

b) Twenty days for minor change applications that only require notification, provided that they can proceed if there is no objection from the competent state management agency.

4. For other change requests, the applications shall be processed according to the regulations applicable to new applications, and the time for responding shall be as stipulated in Clauses 1 and 2 of this Article.

5. The Drug Administration Department and the Medical Equipment and Health Works Department (for in vitro diagnostic products) shall consider issuing registration numbers or providing written responses prior to the deadlines set out in Clauses 1 and 3 of this Article when the applicant requests expedited processing as stated in Application Form No. 06/TT issued together with this Circular in the following cases:

a) Drugs meeting special treatment needs listed in the Rare Drugs List issued by the Minister of Health.

b) Drugs needed for urgent treatment in emergency situations, natural disasters, or epidemics.

c) Domestic drugs produced on new production lines meeting Good Manufacturing Practice (GMP) standards within eighteen months from the date of obtaining GMP certification.

d) Vaccines pre-evaluated by the World Health Organization as meeting requirements and considered for registration through an expedited process established and promulgated by the Drug Administration Department.

Article 32. Cases for Withdrawal of Drug Registration Numbers

During the validity period of the registration number, the Ministry of Health will consider and decide to withdraw the registration number for drugs (including in vitro diagnostic products) that have been registered for circulation under the following circumstances:

1. Drugs produced contrary to the approved registration dossier.

2. Drugs having two batches failing quality standards or violating quality standards once but seriously, as concluded by the competent state management agency for drug quality.

3. The manufacturing entity or the registering 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 or authorized Vietnamese or foreign agencies as unsafe for users.

6. Drugs found to infringe intellectual property rights by competent authorities.

7. Drugs failing to implement the change of registration entity as stipulated in Point i, Clause 3, Article 3 or Point d, Clause 2, Article 4 of this Circular within two months from the date the registration entity ceases operations or is terminated by the competent state management authority.

Article 33. Cases for Temporarily Suspending the Acceptance of New Drug Registration Applications and the Issuance of Drug Circulation Registration Numbers for Submitted Applications

The Ministry of Health shall temporarily suspend the acceptance of new drug registration applications and the issuance of drug circulation registration numbers (including in vitro diagnostic reagents) for submitted applications when they fall under any of the following circumstances:

1. The registering entity or drug manufacturing facility has two or more drugs that fail to meet quality standards before circulation or have been suspended from circulation within one year.

2. The registering entity or drug manufacturing facility has drugs withdrawn from circulation as stipulated in Clause 1, Article 32 of this Circular; or falls under any of the circumstances specified in Clauses 4, 5, or 6 of Article 32 of this Circular but fails to notify the Ministry of Health.

3. The registering entity or drug manufacturing facility engages in fraudulent acts, arbitrarily modifies application documents and legal papers of competent state agencies, or uses counterfeit seals or signatures of the registering entities, manufacturing facilities, and related entities in the registration dossier.

4. The registering entity or drug manufacturing facility provides dossiers, data, and information related to technical dossiers including quality standard dossiers, production methods, and stability without being based on research, experimental, or actual production results of the manufacturing facility or the registering entity.

5. The registering entity or drug manufacturing facility provides dossiers, data, and information about drug efficacy, safety, and effectiveness without scientific evidence to prove them.

6. The registering entity or drug manufacturing facility submits drug samples for registration that are not produced or researched by the entity itself as stated in the production registration dossier.

7. The registering entity fails to update drug information as required by the Drug Administration Department as stipulated in Clause 4, Article 9 of this Circular.

Article 34. Authority to Issue Decisions, Responsibility to Notify, and Time Limit for Withdrawing Circulation Registration Numbers, Temporarily Suspending the Acceptance of New Applications, and Temporarily Suspending the Issuance of Registration Numbers

1. The Minister of Health delegates the Director of the Drug Administration Department to issue decisions to withdraw circulation registration numbers, temporarily suspend the acceptance of new applications, and temporarily suspend the issuance of drug registration numbers, and the Director of the Medical Equipment and Construction Department to issue decisions to withdraw circulation registration numbers, temporarily suspend the acceptance of new applications, and temporarily suspend the issuance of in vitro diagnostic reagent registration numbers nationwide.

2. Provincial Departments of Health, Municipal Departments of Health directly under the Central Government, and Health Departments of sectors shall notify the decisions of the Ministry of Health (Drug Administration Department or Medical Equipment and Construction Department for in vitro diagnostic reagents) to withdraw circulation registration numbers or temporarily suspend the acceptance of new applications and the issuance of registration numbers within their jurisdictional areas.

3. The maximum period for temporarily suspending the acceptance of new drug registration applications and the issuance of drug circulation registration numbers for submitted applications, as stipulated in Clauses 1, 2, and 3 of Article 33 of this Circular, is two years, starting from the date of signing the Decision to withdraw the second drug circulation registration number or to suspend circulation, or from the date of the final decision by a competent state management agency regarding the actions stipulated in Clause 3 of Article 33 of this Circular.

4. The maximum period for temporarily suspending the acceptance of new drug registration applications and the issuance of drug circulation registration numbers for submitted applications, as stipulated in Points 4, 5, and 6 of Clause 33 of this Circular, is one year, starting from the date of the final notification of violations of the relevant regulations by the registering entity.

5. The maximum period for temporarily suspending the acceptance of new drug registration applications and the issuance of drug circulation registration numbers for submitted applications, as stipulated in Clause 7 of Article 33 of this Circular, is six months, starting from the date of the final notification of violations of the relevant regulations by the registering entity.

Chapter V

ORGANIZATION AND ACTIVITIES OF THE REVIEW EXPERTS AND

ADVISORY BOARD FOR ISSUING DRUG CIRCULATION REGISTRATION NUMBERS

Article 35. Organization and activities of the Advisory Council for Drug Registration Number Issuance

1. The Ministry of Health shall establish the Advisory Council for Drug Registration Number Issuance (including in vitro diagnostic products).

2. The Advisory Council for Drug Registration Number Issuance shall advise the Minister of Health on issuing registration numbers for drugs circulating in Vietnam; policies harmonizing drug registration regulations with those of countries in the region and worldwide; and policies on drug production, importation, and circulation in Vietnam, including the use of drugs on Vietnamese people to assess their safety and efficacy when necessary.

3. The Advisory Council for Drug Registration Number Issuance shall operate under the principle that advisory opinions of the Council must be based on legal grounds and scientific foundations and must be reflected in the minutes of the Advisory Council meetings. The Advisory Council for Drug Registration Number Issuance shall be responsible to the Minister of Health for all advisory opinions related to drug registration.

4. The Drug Administration shall coordinate with the Medical Equipment and Infrastructure Department to advise the Minister of Health on establishing regulations regarding the organization and operation of the Advisory Council for Drug Registration Number Issuance, and the mechanism for cooperation between the Advisory Council for Drug Registration Number Issuance and expert groups during the process of issuing registration numbers for drug circulation.

Article 36. Organization and Activities of Experts and Expert Groups Reviewing Drug Registration Applications

1. The Ministry of Health shall instruct the Drug Administration and the Medical Equipment and Infrastructure Department to establish expert groups reviewing drug registration applications (hereinafter referred to as expert review groups) based on their assigned functions and responsibilities.

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. The expert review groups shall operate under the principle that comments or recommendations from experts must be based on legal grounds and scientific foundations and must be reflected in the minutes of the drug registration application review. Experts shall be responsible to the Director of the Drug Administration and the Head of the Medical Equipment and Infrastructure Department (for in vitro diagnostic products) for the contents, advisory opinions, and recommendations related to the review of drug registration applications.

4. The Drug Administration and the Medical Equipment and Infrastructure Department shall develop and promulgate regulations on criteria for selecting, organizing, and operating expert review groups for drug registration applications; enter into annual contracts with experts; organize reviews, compile review results to submit to the Advisory Council; organize training courses for experts; conduct evaluations of professional competence and compliance with regulations to adjust and supplement experts as appropriate.

Chapter VI

IMPLEMENTATION

Article 37. Effective Date

1. This Circular takes effect from January 15, 2015.

2. Major changes, minor changes, and other changes applicable to drugs already issued registration numbers for circulation as stipulated in Appendix II attached to this Circular shall take effect from April 1, 2015.

3. Repeal Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Minister of Health on drug registration and repeal Article 6 of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of Health amending and supplementing certain provisions of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on implementing the "Good Laboratory Practice" principles; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on implementing the "Good Storage Practice" principles; Circular No. 06/2004/TT-BYT dated May 28, 2004 guiding the production and processing of drugs; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004 of the Ministry of Health on implementing the "Good Manufacturing Practice" principles according to the World Health Organization's recommendations; Circular No. 13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health guiding the operation of drug advertising information; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2010 guiding the operation of drug export and import and direct contact packaging from the date this Circular takes effect.

Article 38. Transitional Provisions

1. Drug registration applications submitted before the effective date of this Circular shall be reviewed and issued registration numbers in accordance with Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Minister of Health on drug registration.

2. Foreign drug registration establishments holding permits for drug and drug raw material business operations in Vietnam issued before the effective date of this Circular may continue to use these permits for drug registration until their expiration dates as indicated on the permits.

Article 39. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 40. Responsibility for Implementation

1. The Drug Administration Department and the Medical Equipment and Health Works Department shall be responsible based on their assigned functions and tasks and the ASEAN harmonization roadmap for drug registration to:

a) Organize and implement the provisions of this Circular;

b) Update, compile, and issue the Common ASEAN Technical Document (ACTD), technical guidelines, and other relevant guidelines for ASEAN drug registration so that related entities can implement them;

c) Update the list of drugs granted registration numbers by the Ministry of Health in batches and other drug registration information on the Drug Administration Department's electronic information website or the Ministry of Health's electronic portal for in vitro diagnostic products;

d) Develop, issue, and organize the implementation of standard operating procedures (SOPs), drug registration guidebooks (QM), and expedited review and registration number issuance processes for vaccines pre-evaluated by the World Health Organization and found to meet requirements;

2. Provincial Health Departments shall be responsible for inspecting and auditing the implementation of this Circular by pharmaceutical production and trading units within their jurisdiction;

3. Units under the Ministry of Health, Vietnam Pharmaceutical Joint Stock Corporation, drug trading establishments, and foreign companies with permits to operate in the pharmaceutical sector shall be responsible for implementing this Circular;

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals shall report to the Ministry of Health (the Drug Administration Department and the Medical Equipment and Health Works Department for in vitro diagnostic products) for consideration and resolution./.