PROCEDURE FOR AMENDMENT AND SUPPLEMENT OF REGISTRATION CERTIFICATE FOR CIRCULATION

Application for Amendment and Supplement

– Registration form

– Letter of Authorization on the registration dossier (if any)

– Corresponding documents related to major and minor changes as stipulated in Appendix II issued with Circular No. 08/2022/TT-BYT. For vaccines from the same manufacturing facility or holder of a drug circulation license accepting changes in the manufacturing facility location in the same country or abroad where the circulation license was issued.

Procedure for Amendment and Supplement of Registration Certificate for Circulation

Within 3 months from the date of receiving the complete dossier, the Drug Administration of Viet Nam shall approve the content of the proposed changes or supplements. In case of non-approval or pending approval, the Drug Administration shall provide a written response stating the reasons.

The procedure is as follows:

a) Within 8 working days from the date of receiving the complete dossier, the Drug Administration conducts a review, categorization, and sends the dossier to experts or assessment units. Within 1 month from the date of receiving the dossier from the Drug Administration, experts and assessment units must complete the assessment report and send it to the Drug Administration for synthesis, concluding the assessment report.

b) Within 12 working days from the date of receiving the assessment report from experts or assessment units, the Drug Administration responds in writing to the dossier that did not meet the requirements or was not approved, stating the reasons. For dossiers that meet the requirements or other cases requiring the opinion of the Council, the Drug Administration transfers them to the Council’s office to organize a Council meeting.

** Amendment and supplementation of the registration certificate for minor changes only require notification:

Within 15 working days from the date of receiving the complete dossier, the Drug Administration classifies and announces the content of minor changes requiring only notification on the Electronic Information Page of the Drug Administration. (In cases where the changed or supplemented content does not match the classification of minor changes requiring only notification, the Drug Administration provides written notification.)

The facility is fully responsible for the content of changes and supplements from the date of receipt indicated on the dossier receipt.

** Within 36 months for cases requiring to add preclinical and clinical documents, equivalent biological documents, stability research documents, or within 12 months for other cases requiring additional documents, from the date of the Drug Administration’s written notification, the registered facility must submit the required additional documents. After this period, if the registered facility does not submit the additional documents, the submitted dossier is no longer valid.

** Within 2 months from the date of receiving the complete additional documents for the specified dossier, the Drug Administration approves the changes and supplements to the registration certificate for circulation for the compliant dossier and provides a written response for the non-compliant or rejected dossier, stating the reasons. The specific steps and timeframes are as follows:

a) Within 5 working days from the date of receiving the complete dossier, the Drug Administration conducts a review, categorization, and sends the dossier to experts or assessment units. Within 8 working days from the date of receiving the dossier from the Drug Administration, experts or assessment units must complete the assessment report and send it to the Drug Administration for synthesis, concluding the assessment report.

b) Within 7 working days from the date of receiving the assessment report from experts or assessment units, the Drug Administration responds in writing to the dossier that did not meet the requirements or was not approved, stating the reasons.

** The deadline for implementing changes and supplements to the registration certificate for the circulation of drugs and drug ingredients is not more than 12 months from the date the Drug Administration signs the approval document for cases of changes and supplements.

** In some cases of changes and supplements, drug registration facilities and drug manufacturing facilities are responsible for self-updating information on labels, drug use instructions, and are not required to submit documents or notify the Drug Administration. These cases include:

a) Implementing labeling of drugs, drug ingredients, and drug use instructions as regulated.

b) Implementing changes, supplements to the content of labels, and drug use instructions according to the Drug Administration’s guidelines instructed by the Council.

c) In addition to cases where it is necessary to resubmit label and drug use instruction samples when there are changes or supplements as regulated in Appendix II issued with this Circular, other changes related to information on labels, drug use instructions, and registration facilities, manufacturing facilities must be self-updated when approved by the Drug Administration for these changes or supplements.

d) Other contents:

– Changing the location, information of drug import facilities, drug ingredient information on the label or drug use instructions.

– Correcting spelling errors on labels, drug use instructions.

– Changing the layout of items in the drug use instructions but not changing the content of the approved drug use instructions.

– Adding information about quality standards on labels, drug use instructions according to the approved dossier by the Drug Administration.

– Removing non-mandatory information on labels, drug use instructions.

Authority to approve changes and supplements to the registration certificate for drug circulation

1. Drug Administration and units decided by the Minister of Health.

2. Drug Administration:

a) Approve changes and supplements to the registration certificate for drug circulation.

b) Publish on the Drug Administration’s electronic information page the content of changes and supplements to the registration certificate for drug circulation for minor changes requiring only notification (Notification).

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.

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