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Drug certificate expiry leads to risk of medicine shortfall

HCMC – Vietnam may face a medicine shortage as over 40% of drug registration certificates will expire at the end of the year, the Ministry of Health said.

According to the ministry, Vietnam has issued over 24,000 drug registration certificates. Some 10,000 are expected to expire on December 31, while the figure will amount to nearly 14,000 next year.

Pharmaceutical supplies have met the demand this year, but the nation will be at risk of drug shortage if the ministry does not promptly extend the expiry dates of the circulation certificates for nearly 14,000 drugs.

Given the current capacity, it took the ministry a month to extend 500 certificates and 24 months for all 14,000 near-expiry certificates.

If new regulations are not issued, a huge volume of pharmaceutical products will be banned under the 2016 law on pharmacies, adversely affecting socioeconomic conditions.

Meanwhile, the shortage would impact medical services and incomes at hospitals, as patients may go abroad for medical treatment, health experts said, adding that pharmaceutical firms may suspend or limit their business activities, worsening unemployment in the pharmaceutical sector.

Thus, the ministry has proposed the Government allow certificates of circulation registration that expire between January 1, 2023, and December 31, 2014, to remain valid.

Medicine circulation registration is aimed at ensuring drugs are circulated in line with regulations and used safely and effectively. If the certificates of circulation registration expire, firms must propose an extension for them.

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