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

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

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.

Reference: Thompson Reuter

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