The official letter 20534/QLD-ĐK Update the information about the use of Mifepristone in combination with Misoprostol for abortion

To:

– Provincial/Municipal Health Services

– Hospitals, institutes with beds directly under Ministry of Health

– Drug registration applicants

Minister of Ministry of Health issued Decision No. 4128/QĐ-BYT dated July 29, 2016 approving the document “National guidelines on reproductive health services”. Pursuant to the conclusions of the Drug Registration Advisory Council – Ministry of Health; aims to ensure the safe and effective use of drugs, Drug Administration of Vietnam requests as follow:

I. For drug registration applicants in Viet Nam:

1. For Mifepristone – containing drugs, Misoprostol – containing drugs for abortion indication granted registration numbers:

1.1. Within 03 months from signing date of this Official Letter, drug registration applicants are required to update and supplement information in the package insert of these drugs, specified:

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2. For Mifepristone – containing drugs, Misoprostol – containing drugs for abortion indication in process of approving at Drug Administration of Vietnam:

Drug Administration of Vietnam only considers to submit to Drug Registration Advisory Council after Drug registration applicants submit updated and supplement document about Indications, Dosage and Administration, Special warning and precautions for use and Contraindication section as prescribed in above instruction (in Section 1.1.1, 1.1.2, 1.1.3) in related part of registration dossier and be validated that meeting requirement.

II. Provincial/Municipal Health Services and Hospitals, institutes with beds directly under Ministry of Health

2.1. Notify medical facilities, drug business facilities in respective localities of enforcing to update and supplement information in the package insert of Mifepristone – containing drugs and Misoprostol – containing drugs for abortion indication as prescribed in section I and manage the abortion by to use drugs is conducted only in medical facilities in accordance with the regulation in Circular No. 43/2013/TT-BYT dated December 11, 2013 by Ministry of Health specifying detailing for assigning professional technicality lines for health facilities system”.
2.2. Intensify monitoring the ADR in the use process and circulation of the drugs, report ADR to National DI & ADR Centre (13-15 Le Thanh Tong, Hanoi) or Regional Centre for Drug Information and Adverse Drug Reactions Monitoring in Ho Chi Minh City (201B Nguyen Chi Thanh, Dis.5, Ho Chi Minh City).
Drug administration of Vietnam notifies the facilities to know and comply.
For General Director
Vice General Director
(Signed and Sealed)

Do Van Dong

DOWNLOAD FULL ENGLISH VERSION HERE: 20534_QLD_ĐK_2017_VNRAS_ENGLISH

Original letter here

Translated by Minh Van