Circular 01/2018/TT-BYT ON DRUG, PHARMACEUTICAL INGREDIENT LABELING AND PACKAGE INSERT

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Circular 01/2018/TT-BYT
Circular 01/2018/TT-BYT
Circular 01/2018/TT-BYT ON DRUG, PHARMACEUTICAL INGREDIENT LABELING AND PACKAGE INSERT
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MINISTRY OF HEALTH                    SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

No. 01/2018/TT-BYT Hanoi, January 18, 2018

 

CIRCULAR

ON DRUG, PHARMACEUTICAL INGREDIENT LABELING
AND PACKAGE INSERT
Pursuant to the Law No. 105/2016/QH13 dated April 06, 2016 on Pharmacy;
Pursuant to the Government’s Decree No. 54/2017/NĐ-CP dated May 08, 2017on detailing a number of articles and guidelines for implementation of the Law on Pharmacy;
Pursuant to the Government’s Decree No. 43/2017/NĐ-CP dated April 14, 2017 on goods labels;
Pursuant to the Government’s Decree No. 75/2017/NĐ-CP dated June 20, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Health;
At the request of General Director of Drug Administration of Vietnam;
The Minister of Health promulgates a Circular on drug and pharmaceutical ingredient labeling and package insert.

Chapter I
GENERAL PROVISIONS

Article 1. Scope

1. This Circular regulates contents, labeling of drugs, pharmaceutical ingredients and package insert for marketing; changing the shelf-life already stated on the label of drug due to national defense, security, control and prevention disease, restore natural disaster.
2. Drugs and pharmaceutical ingredients below do not belong to the scope of this Circular:
a) Drugs and pharmaceutical ingredients for exporting without marketing authorization in Vietnam;
b) Imported drug for non-commercial purposes specified in Clause 1, Article 75 of the Government’s Decree No. 54/2017/NĐ-CP dated May 08, 2017 on detailing a number of articles and guidelines for implementation of the Law on Pharmacy (hereinafter called Decree No. 54/2017/NĐ-CP);
c / Imported drugs used to meet urgent requirements for national defense, security, control and prevention disease, restore natural disasters prescribed in Clause 1, Article 67 of Decree No.54/2017/NĐ -CP.

Circular 01/2018/TT-BYT ON DRUG, PHARMACEUTICAL INGREDIENT LABELING AND PACKAGE INSERT

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