 More than 10 years since its implementation, Vietnam has revised and supplemented the regulatory framework for the pharmaceutical industry to reflect the realities of practice and to catch up with state policy.
The National Assembly passed Law on Pharmacy No. 105/2016/QH13, dated April 6, 2016 (the Law on Pharmacy 2016), which will supersede the Law on Pharmacy No. 34/2005/QH11, dated June 14, 2005 (the Law on Pharmacy 2005) on January 1, 2017. In comparison with the current Law on Pharmacy 2005, the Law on Pharmacy 2016 adds four chapters on state policies on pharmacy and pharmaceutical industry development, pharmacy practice, clinical pharmacy and management of drug prices. State policies Pharmacy practice certificate A backward looking provision of the Law on Pharmacy 2016 is the time limit for examination of the application dossier for obtaining a marketing authorisation licence for a new drug. This period is now increased from six months as regulated in the Law on Pharmacy 2005 to no longer than 12 months from the submission date of the proper application dossier. This is because, as explained by the competent authority, they need more time for examining the clinical trial results and bioequivalent study results, and this prolonged time limit conforms with international customs of about 18 months in some other countries. Management of drug prices The Law on Pharmacy 2016 no longer requires announcement of ceiling prices of medicines which are paid with the state budget and health insurance. The comparison between the drug prices at home and those in countries which have healthcare and commercial conditions similar to Vietnam’s is not prescribed in the Law on Pharmacy 2016. It is hoped that the Law on Pharmacy 2016 will encourage the development of the domestic pharmaceutical industry, and help state authorities manage pharmacy activities more effectively to ensure the quality of drugs delivered to end users. ––––––––––––– |
Pharmacy activities
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