Công văn 22098/QLD-ĐK năm 2017 về thống nhất thông tin chỉ định đối với thuốc chứa Alphachymotrypsin dùng đường uống, ngậm dưới lưỡi do Cục Quản lý Dược ban hành

In order to attain objectives of using medicines appropriately, safely and effectively, and ensuring consistency in printing indications of drugs containing Alphachymotrypsin taken by the oral or sublingual route of administration, the Vietnam Drug Administration demands that: 

I. Entities applying for drug registration in Vietnam:

1. As regards medicines containing Alphachymotrypsin taken by the oral or sublingual route of administration which have been endorsed by registration numbers: 

1.1. Within duration of 03 months of signature of this document, these entities shall be obliged to make a change in indications printed on labels and leaflets of these medicines under the instructions specified in Alphachymotrypsin treatises of the 2015 National Pharmacopoeia, specifically as follows: “Indications: For treatment of oedema developed after trauma, surgery and burn injury”.

1.2. Manner of change: These entities shall make such change as per Clause 4 Article 9 of the Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health on drug registration.

2. As regards applications for registration of medicines containing Alphachymotrypsin taken by the oral or sublingual route of administration which are processed for approval at the Vietnam Drug Administration: 

The Vietnam Drug Administration may consider forwarding these applications to the Advisory Board for grant of the certificate of drug and medical ingredient marketing authorization - a subordinate entity of the Ministry of Health, only after entities applying for drug registration have already submitted supplements required by the instruction given in subparagraph 1.1 above to respective parts of applications and certified as conforming to stated requirements.  

II. Departments of Health of provinces and centrally-controlled cities and the Ministry of Health’s hospitals and healthcare institutions with medical beds:

They must inform healthcare establishments and pharmaceutical businesses under their management of any label replacement and provide instructions for oral or sublingual administration of drugs containing Alphachymotrypsin as specified in subparagraph 1.1 above. 

For your information and compliance.

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