| 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:
- 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.
- 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
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Vietnames and original letter here
Translated by Minh Van
