The official letter 18583/QLD-ĐK about update the package insert of intravenous Citicoline-containing drugs

To:

– Provincial/Municipal Health Services

– Hospitals, institutes with beds directly under Ministry of Health

– Drug registration applicants in Vietnam

To unify the indications and package insert of intravenous Citicoline-containing drugs, pursuant to the conclusions of the Drug Registration Advisory Council – Ministry of Health; in order 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

Notify medical facilities, pharmaceutical business facilities in respective localities of about update and supplement information in the package insert of intravenous Citicoline – containing drugs; At the same time, 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).

1. For drug registration applicants in Viet Nam:
2. For intravenous Citicoline–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 Indications, Dosage and Administration, Contraindications, Special warning and precautions for use, Undesirable effects sections to 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 by Ministry of Health on drug registration.

II. For registration dossiers of intravenous Citicoline–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 applicants submit updated and supplemented information of Indications, Dosage and Administration, Contraindications, Special warning and precautions for use, Undesirable effects in related part of registration dossier in accordance with the Annex enclosed with this Circular 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

The official letter 18583/QLD-ĐK about update the package insert of intravenous Citicoline-containing drugs

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18583_QLD_ĐK_2017_VNRAS_ENGLISH

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Translated by Minh Van