263/qd-Qld Decision: On The List Of 10 Foreign Drugs (Drugs Have First Active, Coordinated The First Active Substances Or Dosage Was First Registered In Vietnam-Post Number K ...

Original Language Title: Quyết định 263/QĐ-QLD: Về việc ban hành danh mục 10 thuốc nước ngoài (thuốc có hoạt chất lần đầu, phối hợp hoạt chất lần đầu hoặc dạng bào chế lần đầu đăng ký tại Việt Nam - số đăng k...

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Number: 263 /QĐ-QLD

Hanoi, day 01 Month 10 the year 2013


V. Release of the category 1. 0 foreign medicine (drug Yes.

active first, coordination of the first or the cytoplasm.

It was first registered in Vietnam. -registration number is valid for 02 years.

were issued by the number of registered regioners in Vietnam-the 83



The Law School, June 14, 2005;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government Regulation, mandate, authority, and organizational structure of the Ministry of Health;

Base Decision Base 53 /2008/QĐ-BYT December 30, 2008 by Secretary of State Y Yes. About regulation. function of the functions, duties, powers and organizational structures of the Qu Bureau Stop. Pharmacy of the Ministry of Health and Decision No. 3106 /QĐ-BYT on August 29, 2011 by the Minister of Health for the amendment, added Article 3 Decision No. 3 53 /2008/QĐ-BYT December 30, 2008 Here. The Ministry of Health regulates the function, duties, powers, and organizational structure of the Department of Management. c of the Ministry of Health;

The Digital Base. 22 /2009/TT-BYT 24/11/2009 of the Ministry of Health regulates the registration of the drug;

The advisory base of the Board of Consultative Affairs registers the drug-the Ministry of Health;

Consider the Chief of the ph. There. Subscriptions to the Drug Administration,


What? 1. It was issued by the decision of this decision, a list of the first 10 drug-based foreign medicines, coordinated first or first-class operations in Vietnam-registered registered numbers for the first time in Vietnam-the number of registered countries in Vietnam-83 years.

What? 2. The manufacturer and the registered drug company is responsible for supplying the drug into Vietnam in accordance with the registered document records with the Ministry of Health. The registration number issued by the Ministry of Health must be printed on the label. Registration number VN2-... -13 has a 2-year value since the date of the decision.

What? 3. During the circulation, the company registers the drug, the manufacturer must coordinate with the treatment facilities to perform according to the existing regulations on prescription drugs (for prescription drugs) and to monitor the effect, safety, the undesirable effect of the drug, and the medication. on the Vietnamese and aggregate, the report follows the current regulation every 06 months on the Bureau of Pharmacology.

What? 4. The manufacturer and the drug registry must fully approve the laws of Vietnam and the Ministry of Health regulations on importing drugs and circulating drugs in Vietnam; if there is any change in the course of the drug circulation in the country and in Vietnam. Men must report directly to the Department of Pharmacology-the Ministry of Health of Vietnam.

What? 5. This decision comes into effect since the date of the issue.

What? 6. The Director of the Department of Health of the Provinces, the central city, the executive producer and the registered company with the drug at Article 1 is responsible for the decision.


Zhang Qiang