Market background

Vietnamese pharmaceutical production and supply capacity is weak. It spends more than USD 1 billion every year on imported drugs. UK medicinal and pharmaceutical products accounted for 11% of total imports in 2013 with a value of £33 million, an increase of 21% year-over-year. (DIT, 2016)

Authorisation

Source: Thompson Reuter

To be distributed in Vietnam, a drug must have a marketing authorisation (MA) number issued by the Drug Administration of Vietnam (DAV) under the Ministry of Health (MOH). Under the Law on Pharmacy No. 105/2016/QH13 (adopted by the National Assembly of Vietnam on 6 April 2016), an MA number for a drug should be issued within 12 months of the receipt of a complete application dossier. In practice, the timeline for issuance of an MA number for a drug can range from 12 to 30 months. Drugs granted MA numbers can be imported into Vietnam without an import licence.

Exceptions

Source: Thompson Reuter

Drugs used for certain special purposes can be imported into and distributed in Vietnam without MA numbers if they are granted import licences.

The exceptions include:

  • Finished drug products containing active ingredients (with or without MA numbers) which are in insufficient supply for treatment demands.
  • Rare drugs.
  • Drugs with:
    • the same trade name, active ingredients, concentration and dosage form as an original brand name drug that is granted a certificate of free sale in Vietnam;
    • the same manufacturer as the original brand name drug or an authorised manufacturer; and
    • a price lower than that of the original brand name drug being sold in Vietnam, at the request of the Minister of Health.
  • Drugs used for emergency demands of national defence and security, prevention and elimination of epidemics, disaster recovery or need for special treatment.
  • Drugs used for health programs of the state.
  • Drugs for aid or humanitarian aid.
  • Drugs used for clinical trials, bioequivalence studies, bio-availability assessments, as samples for registration, testing, or scientific research, or for display at fairs or exhibitions.
  • Drugs used for other non-commercial purposes.
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