Decision No. 195/QD-QLD dated June 29, 2011 of the Drug Administration of Vietnam promulgating drugs produced domestically are allowed to circulate in Vietnam

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Decision No. 195/QD-QLD dated June 29, 2011 of the Drug Administration of Vietnam promulgating drugs produced domestically are allowed to circulate in Vietnam
Issuing body: Effective date:
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Official number:195/QD-QLDSigner:Truong Quoc Cuong
Type:DecisionExpiry date:Updating
Issuing date:29/06/2011Effect status:
Known

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Fields:Medical - Health
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Effect status: Known

THE MINISTRY OF FINANCE

THE DRUG ADMINISTRATION OF VIETNAM

Decision No. 195/QD-QLD dated June 29, 2011 of the Drug Administration of Vietnam promulgating drugs produced domestically are allowed to circulate in Vietnam

DIRECTOR OF DRUG ADMINISTRATION OF VIETNAM

Pursuant to the Law on Pharmacy dated June 14, 2005;

Pursuant to the Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decision No. 53/2008/QD-BYT dated December 30, 2008 of the Minister of Health regulating functions, tasks, rights and organization structure of the Drug Administration of Vietnam directly under the Ministry of Health;

Pursuant to the Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on registration of drugs;

Pursuant to the Circular No. 06/2004/TT-BYT dated May 28, 2004 of the Ministry of Health guiding the production and processing of drugs;

At the proposal of Head of Drug Registration Department,

DECIDES:

Article 1. To promulgate 01 type of drug produced domestically that is allowed to circulate in Vietnam.

1. Oder party: Central Pharmaceutical one-member limited liability company No. 1

Address: 356A, Giai Phong street, Thanh Xuan district, Hanoi

2. Processor: (production site): Euvipharm Pharmaceutical Joint Stock Company

Address: Binh Tien 2 hamlet, Duc Hoa Ha commune, Duc Hoa, Long An

 

No.

Name, content

Package procedure

Standard

Age (month)

Registration number

1

Kalimate

(Calcium polystyrene sulfonate 5 gram)

30 packages x 5 gram medicinal power per box

TCCS

48

GC-0138-11

Article 2. Company must print the registration number supplied by the Ministry of Health to the drug mark and comply with all relevant to producing and circulating drug. The registration number is valid in 05 years from the signing date.

Article 3. To stop the validity of the registration number: VD-12734-10 at the Decision No. 339/QD-QLD dated October 25, 2010 of the Director of Drug Administration of Vietnam.

Article 4. This Decision takes effect from the issuing date.

Article 5. Directors of provincial and municipal Health Departments and directors of units having drug as in Article 1 shall implement this Decision./.

DIRECTOR

Truong Quoc Cuong

 

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