The official letter 18366/QLD-ĐK Update the package insert of Metformin-containing drug for the treatment of type 2 diabetes

To:       

– Provincial/Municipal Health Services

– Hospitals, institutes with beds directly under Ministry of Health

– Drug registration applicants in Vietnam

Based on the review of clinical studies on the safety of metformin in patients with mild to moderate renal impairment. On April 08, 2016, US Food and Drug Administration (US FDA) requested manufacturers, distributors and drug registration applicants to supplement information on expanding the use of metformin in some patients with kidney function reduction and update recommendations on the use of drug on these patients in the package insert.

Following Official Letter No. 24812/QLD-TT dated December 21, 2016 by Drug Administration of Vietnam regarding providing information about the safety and efficacy of metformin-containing drug to healthcare professionals; and 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 Provincial/Municipal Health Services and Hospitals, institutes with beds directly under Ministry of Health

Continuing to notify medical facilities, pharmaceutical business in respective localities about the information related to recommendation as prescribed in Official Letter No. 24812/QLD-TT dated December 21, 2016 by Drug Administration of Vietnam and guideline in Annex of this Official Letter; At the same time, to intensify monitoring the ADR in the use process and circulation of the drugs, report ADR (if any) 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).

II. For drug registration applicants in Vietnam:

1. For Metformin-containing drugs 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 Dosage and administration, Contraindications, Special warning and precautions for use sections on the label and package insert in accordance with the Annex enclosed with this Official letter.
1.2. Form of update: Drug registration applicants automatically update pursuant to the regulation under Clause 4 Article 9 Circular 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health on drug registration.

2. For registration dossiers of Metformin-containing drugs 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 applicant submit updated and supplement information of Dosage and administration, Contraindications, Special warning and precautions for use in related part of registration dossier in accordance with the Annex enclosed with this Official letter and be validated that meeting requirement.
Drug administration of Vietnam notifies the facilities to know and comply.

For General Director

Vice General Director

(Signed and Sealed)

Nguyen Tat Dat

MINISTRY OF HEALTH                                        SOCIALIST REPUBLIC OF VIETNAM

DRUG ADMINISTRATION OF VIET NAM                    Independence – Freedom – Happiness

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ANNEX

The revised/supplemented content of Metformin-containing drugs

(Attached to Official Letter No.18366/QLD-ĐK dated November 08 2017 by Drug Administration of Vietnam)

[ For all concurrent Metformin-containing drugs, information on the label and package insert must be revised (supplement or amend) in order to reflect the information provided below]

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The official letter 18366/QLD-ĐK update the package insert of Metformin-containing drug for the treatment of type 2 diabetes

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18366_QLD_DK_2017_ENGLISH_VNRAS

Translated by Minh Van

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