Amending, supplementing a number of regulations on announcement of eligibility to produce preparations

On October 10, 2024, Government issues Decree No. 129/2024/ND-CP on amending, and supplementing several Articles of Decree No. 91/2016/ND-CP dated July 01, 2016 on the management of insecticidal or germicidal chemicals and preparations for household and medical use, and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles concerning business investment conditions under state management of the Ministry of Health.

Amend, and supplement the announcement of eligibility to produce preparations as follows:

- Before producing preparations, a production establishment’s at-law representative shall send its dossier of announcement prescribed in Article 7 of this Decree directly, or online or by post to the provincial-level Health Department of the locality where the production establishment is headquartered. The establishment may produce preparations after the information specified in Clause 2 of this Article is disclosed by the provincial-level Health Department on its website.

-  Within 3 working days from the date on which the production establishment's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the production establishment.

-  Within 15 days after having one of the changes in the name, address and telephone number, the production establishment shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

Announcement of eligibility to produce preparations

Amend, and supplement regulations on announcement of eligibility for assay

-  Within 3 working days from the date on which the assaying establishment 's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the assaying establishment; and the list of assay processes that the assaying establishment announces its eligibility to undertake.

-  Within 15 days after having one of the changes in the name, address and the list of assay processes that the assaying establishment announces its eligibility to undertake, the assaying establishment shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

This Decree takes effect on November 30, 2024.
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