Vietnam: New Regulations in for Pharmaceuticals

On March 29, 2013 the Ministry of Health issued a Circular amending and supplementing the Law on Pharmacy 2005.

Under the Law on Pharmacy 2005, the Ministry of Health is responsible for granting all pharmaceutical certificates. Under the new Circular amending the law, the Ministry of Health has authorized the Provincial Department of Health to grant certificates for foreign-owned enterprises’ drug manufacturing, drug maintenance, drug testing and import of drugs. The amendment took affect May 14th, 2013.

New regulatory forms issued with the Circular include forms for:

  • A grant of pharmaceutical trading license
  • The original pharmaceutical practice certificate of the professional manager corresponding to the pharmaceutical trading form
  • A copy of the business registration certificate for individual businesses or the enterprise registration certificate which is certified or signed by its owner
  • Technical documents stipulated by the Health Ministry for pharmaceutical trading establishments subject to appraisal