Chương IV Thông tư 08/2022/TT-BYT: Thủ tục cấp, gia hạn, thay đổi, bổ sung giấy đăng ký lưu hành thuốc, nguyên liệu làm thuốc; trình tự thẩm định hồ sơ nhập khẩu thuốc chưa có giấy đăng ký lưu hành

Chapter IV

PROCEDURES FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION OF DRUGS/MEDICINAL MATERIALS; PROCESSING OF APPLICATIONS FOR IMPORT OF DRUGS WITH MARKETING AUTHORIZATION

Article 33. Drugs eligible for quick and simplified validation

1. Drugs eligible for quick validation

A marketing application will be eligible for quick validation procedures if one of the following conditions is satisfied:

a) A drug included in the list of rare drugs announced by the Minister of Health of Vietnam;

b) Drugs serving urgent needs for national defense and security, epidemic control or disaster recovery;

c) Domestic drugs that are manufactured by production lines that satisfy GMP, GMP-EU, GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate;

d) Vaccines that have been prequalified by WHO; vaccines used for national expanded immunization programs;

dd) Specialty drugs, drugs with special dosage forms where not more than 02 similar drugs (with the same active ingredients, dosage form, content or concentration) have an unexpired marketing authorization in Vietnam when the application is submitted, including:

- Antineoplastic drugs;

- Next-gen antiviral drugs;

- Next-gen antibiotics;

- Drugs for treatment of haemorrhagic fever, tuberculosis, malaria;

- Immunosuppresive drugs used in organ transplantation.

e) Drugs that can be domestically manufactured, including:

- Antineoplastic drugs, vaccines, biologicals, next-gen antiviral drugs, next-gen antibiotics, and immunosuppresive drugs used in organ transplantation that are manufactured in Vietnam under a processing agreement or technology transfers agreement;

- Herbal drugs under a national, ministerial or provincial research which has been accepted; drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards;

- New domestic drugs that have undergone clinical trial in Vietnam;

g) New antineoplastic drugs, next-gen antiviral drugs, next-gen antibiotics, and reference biologicals;

h) Proprietary drugs that are manufactured in Vietnam under a processing agreement or technology transfer agreement;

i) Drug whose manufacturer is changed resulting in application for issuance of a new marketing authorization as prescribed in Point b Clause 2 Article 55 of the Law on Pharmacy.

2. Drugs eligible for simplified validation procedures

A marketing application will be eligible for simplified validation procedures if all of the following conditions are satisfied:

a) The drug is manufactured in a factory that periodically undergoes GMP inspection by the Drug Administration of Vietnam;

b) The drug is included in the list of OTC drugs;

c) The dosage form of the drug is not modified-release;

d) The drug is not directly applied to the eye.

Article 34. Authority to approve issuance, renewal, revision of marketing authorization of drugs and medicinal materials

1. The Drug Administration of Vietnam and authorities decided by the Minister of Health of Vietnam (hereinafter referred to as “validating units”) shall validate and consider granting applications for issuance, renewal and revision of marketing authorization of drugs and medicinal materials, except for regulations in Point b Clause 2 of this Article.

2. The Drug Administration of Vietnam shall:

a) issue, renew and approve revision of the marketing authorization of drugs, declaration of proprietary drugs, reference biologicals, drugs with demonstrated bioequivalence on the basis of opinions given by the Advisory Board in each specific case or general guidelines given by the Advisory Board applied to each type of revision, except the case in Point b of this Clause;

b) publish on its website the minor variations to the marketing authorization of drugs/medicinal materials that only require notification.

Article 35. General procedures for issuance, renewal, revision of marketing authorization of drugs/medicinal materials

1. Applications can be submitted online, in person or by post to the Drug Administration of Vietnam.

2. After receiving adequate documents, the Drug Administration of Vietnam shall issue the receipt note (using form No. 9/TT enclosed herewith) to the applicant.

The Drug Administration of Vietnam shall receive application without requesting the applicant to submit CPP in the case prescribed in Point e Clause 4 Article 22 of this Circular and the documents specified in Point b Clause 1 Article 24 of this Circular at the submission time.

3. Receipt of applications for import of unapproved drugs shall comply with the provisions of Point b Clause 1 Article 77 of Decree No. 54/2017/ND-CP.

4. Validation of applications for issuance, renewal, revision of the marketing authorization of drugs/medicinal materials and applications for import of unapproved drugs:

a) The Drug Administration of Vietnam shall send received applications to validators or units assigned by the Ministry of Health of Vietnam on the basis of the list of validators approved by the Drug Administration of Vietnam or validating units;

b) On the basis of opinions given by the validators or validating units and relevant information, the Drug Administration of Vietnam shall propose approval or rejection of the applications for issuance, renewal, revision of the marketing authorization of drugs/medicinal materials or applications for import of unapproved drugs. The proposal of the Drug Administration of Vietnam shall be written on the validation record;

c) The Drug Administration of Vietnam shall consult with the Advisory Board about its proposal as prescribed in Point b of this Clause in the following cases:

- Whether to grant, renew or approve the revision of the marketing authorization of drugs/medicinal materials, except for the cases specified in Clause 5 of this Article;

- Whether to declare the proprietary drug or reference biological, unless the applicant is not required to submit application for classification of proprietary drug or reference biological as prescribed in Article 9 of this Circular;

- Whether to grant the license to import an unapproved drug;

- Other cases proposed by the Drug Administration of Vietnam to serve urgent treatment.

5. An application for issuance, renewal or revision of the marketing authorization of a drug/medicinal material may be modified up to 03 times. If the application is still unsatisfactory after 03 times of modification, the Drug Administration of Vietnam shall give a notification to reject the application. The submitted application will no longer be valid.

Article 36. Procedures for granting marketing authorization of drugs and validation of applications for import of unapproved drugs

1. Within 12 months from the receipt of an adequate application for issuance of the marketing authorization (except the case specified in Article 39 of this Circular), the Drug Administration of Vietnam shall issue marketing authorization. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall respond in writing and provide explanation. Processing deadlines:

a) Within 02 months from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 06 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 02 months from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response if the application is rejected and provide explanation. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 01 month from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

2. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents, or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

3. Within 06 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory, or give written response to rejected application according to the conclusions given by the Advisory Board, or give written response and provide explanation for the application yet to be approved. Processing deadlines:

a) Within 01 month from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 02 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 01 month from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the rejected application. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 01 month from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

4. Validation of applications for import of unapproved drugs:

a) Within 05 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall transfer it to the validator or validating unit.

The validation must be completed within a maximum duration of 30 days from the receipt of application if clinical data or documents proving that the drug is similar to a reference biological are not mandatory, or 60 days from the receipt of application if clinical data or documents proving that the drug is similar to a reference biological are mandatory;

b) Within 20 days from the receipt of the validation record:

- The Drug Administration of Vietnam shall consolidate opinions from the validators or validating units and consider relevant information to decide whether to propose the grant of the import license.

- If an application needs to be submitted to the Advisory Board as prescribed in Point c Clause 4 Article 35 of this Circular, the Drug Administration of Vietnam shall submit it in the next meeting;

- If an application is unsatisfactory, the Drug Administration of Vietnam shall send written response and provide explanation.

c) Within 05 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall grant the import license if the application is satisfactory, or give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board;

d) After receiving the modified application from the applicant, the Drug Administration of Vietnam shall follow instructions in Points a, b and c of this Clause.

If the Advisory Board requests modification of the application without resubmission of the application, the Drug Administration of Vietnam shall inform the applicant and, if the modified application is satisfactory, grant the license without resubmitting to the Advisory Board.

Article 37. Procedures for renewal of marketing authorization of drugs/medicinal materials

1. Within 03 months from the receipt of an adequate application, the Drug Administration of Vietnam shall renew the marketing authorization of drug/medicinal material. If the renewal application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response and provide explanation. Processing deadlines:

a) Within 08 working days from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 01 month from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 12 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the rejected application. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 06 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

2. The applicant shall provide additional documents within 12 months from the day on which it receives a request from the Drug Administration of Vietnam. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

Additional documents shall be examined in accordance with the provisions of Clause 1 of this Article.

Article 38. Procedures for revision of unexpired marketing authorization of drugs/medicinal materials

1. Revision of the marketing authorization of drug/medicinal material, except for the cases specified in Clause 2 of this Article

The Drug Administration of Vietnam shall process the revision application within 03 months from the receipt of adequate documents. If a revision application is rejected or yet to be approved, the Drug Administration of Vietnam shall give a written response and provide explanation. Processing deadlines:

a) Within 08 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 01 month from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

b) Within 12 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is rejected or yet to be approved. If an application is satisfactory or requires opinions from the Advisory Board, the Drug Administration of Vietnam shall transfer it to the Office of the Advisory Board for holding a meeting;

c) Within 06 working days from the receipt of the application from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence, approve revised contents or give written response and provide explanation for the application which is rejected or yet to be approved according to conclusions given by the Advisory Board.

2. Minor variations that only require notification:

Within 15 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall classify and publish minor variations that only require notification on its website. If revised contents can not be classified as minor variations that only require notification, the Drug Administration of Vietnam shall give a written notification.

The applicant shall make and assume the full responsibility for revised contents from the date of the application receipt note. The applicant/drug manufacturer shall assume legal responsibility for the accuracy and truthfulness of minor variations that only require notification, and retain relevant documents to serve competent authorities’ post-sale inspection.

3. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

4. Within 02 months from the receipt of adequate additional documents as prescribed in Clause 1 of this Article, the Drug Administration of Vietnam shall approve the revision if the application is satisfactory, or give a written response and provide explanation for the application which is rejected or yet to be approved. Processing deadlines:

a) Within 05 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 08 working days from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

b) Within 07 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is rejected or yet to be approved. If an application is satisfactory or requires opinions from the Advisory Board, the Drug Administration of Vietnam shall transfer it to the Office of the Advisory Board for holding a meeting;

c) Within 06 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence; approve the revision if the application is satisfactory. The Drug Administration of Vietnam shall send written response and provide explanation for the application which is rejected or yet to be approved according to conclusions given by the Advisory Board.

5. The implementation of the revisions to the marketing authorization must be completed within 12 months from the day on which the Drug Administration of Vietnam gives approval for such revisions.

6. The applicant or drug manufacturer shall update the label and package insert of the drug without submitting a revision application or sending notification to the Drug Administration of Vietnam in the following cases:

a) The label or package insert is provided in accordance with Clause 2 Article 35 of the Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of Vietnam;

b) The label or package insert is revised according to the Official Dispatch given by the Drug Administration of Vietnam to instruct the implementation of guidelines of the Advisory Board;

c) Unless the the sample label or package insert has to be submitted in cases of revision specified in Appendix II enclosed herewith, other revisions to the label or package insert shall be updated by the applicant or manufacturer after they are approved by the Drug Administration of Vietnam.

d) Other contents:

- Change to information position or information about the importer on the label or package insert;

- Correction of spelling errors on the label or package insert;

- Change in the order of information on the package insert without change to information thereof which has been approved;

- Addition of specifications to the label or package insert approved by the Drug Administration of Vietnam;

- Removal of information other than the compulsory one on the label or package insert.

Article 39. Issuance of marketing authorization of drugs following quick and simplified validation procedures and grant of marketing authorization of medicinal materials

1. Within 06 months from the receipt of an adequate application, the Drug Administration of Vietnam shall grant the marketing authorization of drugs/medicinal materials. If an application is rejected or yet to be approved, the Drug Administration of Vietnam shall a written response and provide explanation. Processing deadlines:

a) Within 16 working days from the receipt of an adequate application, the Drug Administration of Vietnam shall classify and transfer it to the validator or validating unit. Within 03 months from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

b) Within 18 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is yet to be approved. If an application is satisfactory or unsatisfactory or requires opinions from the Advisory Board, the Drug Administration of Vietnam shall transfer it to the Office of the Advisory Board for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.

2. Within 36 months from the day on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents (or 12 months for other documents), the applicant shall provide the additional documents as requested. Otherwise, the application will be rejected.

During the validation of the submitted application, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents about the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5 Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board. Processing deadlines:

a) Within 10 working days from the receipt of an application, the Drug Administration of Vietnam shall consider, classify and transfer it to the validator or validating unit. Within 16 working days from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 08 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a written response and provide explanation for the application which is yet to be approved. If the Drug Administration of Vietnam makes the proposal to approve or reject or needs to obtain opinions from the Advisory Board about an application, it shall transfer the application to the Office of the Advisory Board for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Advisory Board shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Advisory Board, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall give written response and provide explanation for the application which is rejected or yet to be approved according to the conclusions given by the Advisory Board.