Amendment to the procedures for extending the registration number of disinfectant products used in the medical field in Vietnam

Amendment to the procedures for extending the registration number of disinfectant products used in the medical field in Vietnam

According to the provisions stipulated in Decision 3613/QD-BYT of 2024, the procedures for extending the registration number of disinfectant products used in the medical field in Vietnam are amended as follows:

Step 1: The entity renewing the registration number shall submit documents to the Reception and Result Delivery Department of the Ministry of Health.

Step 2: After receiving the complete registration renewal documents and the dossier appraisal fee, the Department of Medical Environment Management, Ministry of Health shall send the entity renewing the registration number a Receipt of Dossier according to Form No. 06 in Appendix III promulgated with Decree 91/2016/ND-CP.

Step 3: Within 30 days from the date indicated on the Receipt of Dossier, the Department of Medical Environment Management, Ministry of Health shall notify in writing to the entity renewing the registration number regarding the request for amendment, supplementation of the dossier; disallowing or approving the renewal of the registration number.

Step 4: Upon receiving the written request for amendment and supplementation, within 30 days from the date indicated on the notification requesting amendment, of which the registration is no longer valid, the registration renewal entity must amend, supplement with an explanatory document and send it to the Ministry of Health. The date of receiving supplementary or modified dossier shall be recorded on the Receipt of Dossier. If the above deadline is missed, the registration renewal dossier will be canceled.

In case the registration entity does not submit the dossier on time due to force majeure reasons such as natural disasters, calamities, epidemics, fire, etc., they are permitted to submit a delayed dossier as per regulations but no more than 12 months from the expiration date of dossier supplementation, accompanied by an explanatory document.

Step 5: If there are no further requests for amendment or supplementation, the Department of Medical Environment Management, Ministry of Health must proceed with the renewal of the registration number.

Refer to more details at Decision 3613/QD-BYT which is effective from November 30, 2024.

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