To:

- Departments of Health of provinces and\r\n centrally-governed cities;
\r\n - Ministry of Health’s hospitals and healthcare institutions equipped with\r\n medical beds;
\r\n - Entities applying for drug registration in Vietnam;

In order to attain objectives of using medicines\r\nappropriately, safely and effectively, and ensuring consistency in printing\r\nindications of drugs containing Alphachymotrypsin taken by the oral or\r\nsublingual route of administration, the Vietnam Drug Administration demands\r\nthat: 

I. Entities applying for drug registration in\r\nVietnam:

1. As regards medicines containing\r\nAlphachymotrypsin taken by the oral or sublingual route of administration which\r\nhave been endorsed by registration numbers: 

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

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

2. As regards applications for registration of\r\nmedicines containing Alphachymotrypsin taken by the oral or sublingual route of\r\nadministration which are processed for approval at the Vietnam Drug\r\nAdministration: 

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II. Departments of Health of provinces and\r\ncentrally-controlled cities and the Ministry of Health’s hospitals and\r\nhealthcare institutions with medical beds:

They must inform healthcare establishments and\r\npharmaceutical businesses under their management of any label replacement and\r\nprovide instructions for oral or sublingual administration of drugs containing\r\nAlphachymotrypsin as specified in subparagraph 1.1 above. 

For your information and compliance.

PP. THE\r\n DIRECTOR
\r\n THE DEPUTY DIRECTOR
\r\n
\r\n
\r\n
\r\n
\r\n Do Van Dong