| MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIET NAM |
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ——o0o—–
|
| No. 22098/QLD-ĐK: Unifying indications of drugs containing Alpha chymotrypsin following by oral route, sublingual route | Hanoi, December 26, 2017 |
To:
– Provincial/Municipal Health Services
– Hospitals, institutes with beds directly under Ministry of Health
– Drug registration applicants
Aims to ensure the safe and effective use of drugs and unify the indications of drugs containing Alpha chymotrypsin following by oral route or sublingual route, Drug Administration of Vietnam requests as follow:
I. For drug registration applicants in Viet Nam:
1. For drugs containing Alpha chymotrypsin following by oral route or sublingual route granted registration numbers:
1.1. Within 03 months from signing date of this official letter, drug registration applicants are requested to conduct the change of writing therapeutic indications of this medicine on the label and instruction for use ……………………
Dowload file for full version…
1.2. Form of update: drug registration applicants conduct the update pursuant to the regulation under Clause 4 Article 9 Circular 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health on drug registration.
2. For registration dossiers of drugs containing Alpha chymotrypsin following by oral route or sublingual route in process of approving at Drug Administration of Vietnam:
Drug Administration of Vietnam only considers to submit to Drug Registration Advisory Committee after Drug registration applicant submit supporting document of indications in related part of registration dossier as per above instruction in Section 1.1 and be validated that meeting requirement.
II. Provincial/Municipal Health Services and Hospitals, institutes with beds directly under Ministry of Health
Report to medical facilities, drug business facilities in respective localities about the change of label and instruction for use of drugs containing Alpha chymotrypsin following by oral route or sublingual route in above section 1.1.
Drug administration of Vietnam notifies the facilities to know and comply.
For General Director
Vice General Director
(signed and sealed)
Do Van Dong
Copy please to refer vnras.com
The official letter No. 22098/QLD-ĐK Vietnamese version and original letter here
DOWNLOAD FULL ENGLISH VERSION HERE: 22098_QLD_ĐK_2017_ENGLISH
Translated by Minh Van
