The official letter 5750/QLD-ĐK updating pharmacology information of hydrazine-containing medicines

The official letter 5750/QLD-ĐK Updating pharmacology information of hydrazine-containing medicines

Respectfully to:

• Departments of Health of central-affiliated cities and provinces.
• Hospitals, medical facilities with beds under the ministry of Health
• Registering company have drugs circulating in Vietnam

Recently, The European medicines agency (EMA) carried out analyzing and evaluating the safety of hydrazine-containing medicines and offer new measures to minimize the risk of effect on heart rhythm when using such medicines.
Following letter number 20391/QLD-TT dated November 2nd 2015 of drug administration of Vietnam on providing information for medical staffs about the safety of hydrazine-containing medicines and based on the conclusions of advisory council for granting drug visa numbers – Ministry of Health, in order to ensure rational, safe and effective use of medicines, Drug of administration of Vietnam requires:

I. With respect to Departments of Health of central-affiliated cities and provinces and Hospital, medical facilities with beds under the ministry of Health

Continue informing to medical facilities, local pharmaceutical business units about information related to the warning of EMA which was stated in letter number 20391/QLD-TT dated November 2nd 2015 of DAV and the guidance specified in the annexes of this letter; enhance monitoring undesirable effects of drugs in the process of use and circulation; send the ADR reports (if any) to the national center of Drug Information and Adverse drug reactions (13-15 Le Thanh Tong Str., Hanoi) or the regional center of Drug information and adverse drug reactions in Ho Chi Minh City (201B Nguyen Chi Thanh Str., District 5, Ho Chi Minh City)

II. With respect to registering company having drugs circulating in Vietnam

1. For Hydrazine-containing medicines which were granted visa numbers:

1.1. Within 3 months from the signature date of this letter, require the registering companies to update, supplement information about posology and method of administration, contraindications, warnings and precautions, drug interactions and other kinds of interaction, undesirable effects on the labels, package inserts as per the contents of the annexes attached with this letter.
1.2. Updating method: Registering companies implement automatic update according to Clause 4 Article 9, Circular number 44/2014/TT-BYT dated November 25th 2014 on drug registration of Ministry of Health.

2. For registration dossiers of hydrazine-containing medicines which are pending:

Drug administration will only consider granting visa numbers when registering companies have already submitted documents to update, supplement information as specified in point 1.1 of this letter to relevant parts of registration dossiers and the dossiers met the requirements.
Drug administration informs the units to know and implement./.

DEPUTY DIRECTOR GENERAL OF DRUG ADMINISTRATION OF VIETNAM

NGUYEN TAT DAT

The official letter 5750/QLD-ĐK Updating pharmacology information of hydrazine-containing medicines

DOWNLOAD FOR FULL ENGLISH VERSION

5750_QLD_ĐK_2017_VNRAS_ENGLISH

COPY PLEASE REFER TO vnras.com

TRANSLATED BY DAN TIGER