The official letter 456/QLD-ĐK about: registration, importing purchase orders of Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine, oral Nitroglycerin-containing drugs

318
The official letter 456/QLD-ĐK
The official letter 456/QLD-ĐK
The official letter 456/QLD-ĐK about: registration, importing purchase orders of Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine, oral Nitroglycerin-containing drugs
5 (100%) 11 votes
MINISTRY OF HEALTH

DRUG ADMINISTRATION OF VIET NAM

————————

SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

——o0o—–

N0 456/QLD-ĐK about: registration, importing purchase orders of Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine, oral Nitroglycerin-containing drugs Hanoi, January 11, 2018

To:      

Registration applicants, manufacturers of drugs circulating in Vietnam.

Pursuant to the conclusion of Drug Registration Advisory Council – Ministry of Health regarding to Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine and oral Nitroglycerin-containing drugs, in order to ensure the safe and effective use of drugs, Drug Administration of Vietnam requests as follow:

  1. Suspending receiving and approving importing purchase orders of finished products with Marketing Authorization has not yetbeen granted, application dossiers, extension dossiers and variations/supplement dossiers for marketing authorizations of Sulfaguanidin-containing drugs; oral single ingredient drugs containing Ephedrine and oral Nitroglycerin-containing drugs.
  2. About Sulfaguanidin-containing drugs; oral single ingredient drugs containing Ephedrine and oral Nitroglycerin-containing drugs with valid marketing authorization or prior the expiry date circulating on the market: within 6 months from date of issue this Official Letter, registrations applicants are required to report safety and efficacy of Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine and oral Nitroglycerin-containing drugs (according to Form 3A/TT, 3B/TT regulated in Cicular 44/2014/TT-BYT date November 25, 2014 by Ministry of Health on registration of drugs). Based on the reports of facilities, Drug Administration of Vietnam will consider decision on the circulation of these drugs.

Drug administration of Vietnam notifies the facilities to know and comply.

For General Director

Vice General Director

(Signed and Sealed)

Do Van Dong

The official letter 456/QLD-ĐK about: registration, importing purchase orders of Sulfaguanidin-containing drugs, oral single ingredient drugs containing Ephedrine, oral Nitroglycerin-containing drugs

DOWNLOAD FULL ENGLISH VERSION HERE

456_QLD_ĐK_2017_VNRAS_ENGLISH

Copy please refer vnras.com

Vietnames and original letter here

Translated by Minh Van

LEAVE A REPLY

Please enter your comment!
Please enter your name here