The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines

The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines

To:   

• Provincial/municipal Departments of Health;
• Hospitals, institutes with beds belong to the Ministry of Health;
• Applicants, manufacturers have drugs marketing in Vietnam.

After the official letter 6132/QLD-ĐK dated June 16, 2010 by Drug Administration of VN about way of writing indication, contra-indication and dosage of glucosamine-containing medicines and based on the conclusions of the advisory Board of the issuance of medicine registration numbers – Ministry of Health for indication of Glucosamine-containing medicines; to ensure objective for using drugs reasonably, safely and effectively, Drug Administration notify as follows:

1. Amending way of writing indication of glucosamine-containing medicines in the official letter 6132/QLD-ĐK dated June 16, 2010 by Drug Administration of VN is “Relief the mild to moderate symptoms of knee osteoarthritis”. The content of writing guidelines contra-indication, dosage of the drug is uniformly applied as the official letter 6132/QLD-DK dated June 16, 2010 by Drug Administration of Vietnam.
2. Suggest Provincial/municipal Departments of Health and hospitals, institutes with beds belong to Ministry of Health: inform medical units, companies on the local about the information related to indication of glucosamine at above item 1.
3. Applicants, manufacturers:
   • For glucosamine-containing medicines have been licensed for marketing:

• Within 3 months from the date of signing of this official letter. Request applicants, manufacturers to implement: edit the information of indication is “Relief the mild to moderate symptoms of knee osteoarthritis” in related parts of label, package insert and/or patient information leaflet.
• Updated form: Submit variation/supplement dossier information on label, package insert and/or patient information leaflet following the instruction at Annex II – Circular 22/2009/TT-BYT dated 24/11/2009 of the Ministry of Health, guiding medicine registration.
  • For drug registration dossiers with glucosamine-containing ingredient pending approval at Drug Administration of Vietnam:
• Drug Administration only considers grant registration numbers after applicants submitted variation/supplement documents of section indication as above mention at item 1 into related documents of dossier and satisfactory evaluation.

Drug Administration of Vietnam notifies units to know and implement.

The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines