As of the end of 2021, there were 22,000 valid drug circulation registration certificates. Of this number, 12,896 certificates will expire in the period from 2011 to December 31, 2022 if the certificates cannot be extended.

In fact, the problem was anticipated by the Government in Q3 2021, when the Covid-19 pandemic reached its peak and social distancing on a large scale had a big impact, hindering the management of the anti-epidemic apparatus.

Patients affected

With the spirit of ‘special tasks needs special policies’, the National Assembly shows its companionship with the Government when releasing Resolution 12 on December 30, 2021 which helped to promptly remove difficulties and problems during the implementation of measures to fight the pandemic.

The resolution showed the strong determination of the National Assembly’s Standing Committee to ensure sufficient supply of drugs for treatment, and create favorable conditions for enterprises to manufacture and distribute drugs in accordance with the laws.

Clause 5 of Article 6 of the resolution said: “For certificates of drugs and medicinal ingredients that expire from the day the resolution takes effect to the day before December 31, 2022, and which cannot follow procedures for an extension because of the pandemic, the drugs will still be allowed to be in use until the end of December 31, 2022.”

The extension of the expired registration for drug circulation has not been implemented over the last three months. Customs agencies and other agencies say the words “cannot follow procedures for an extension for the drug circulation because of the pandemic” is not clear enough, which leads to different ways of interpretation. 

They said they need to see a document of the Ministry of Health which gives detailed guidance about drugs that are subject to the regulation to allow customs clearance, and they will only allow customs clearance of Covid-19 treatment drugs.

Meanwhile, the National Assembly’s Standing Committee only requires ministries to give guidance to implement Clauses 1 and 2 of the article, and doesn’t require detailed guidance for Clause 5.

The lack of effective cooperation among state management agencies, and the confusion of the Ministry of Health in implementing the National Assembly’s Resolution 12 have caused difficulties for pharmacy firms. Many drugs and medical ingredients cannot get customs clearance, leading to a risk of supply disruption and lack of drugs for treatment.

According to the Vietnamese Pharmaceutical Association (VPA), over 500 circulation registration certificates have expired, including drugs that serve the treatment of Covid-19, including antibiotics, and drugs to treat chronic diseases and vaccines. Some pharmacy firms said they have hundreds of registration numbers which have not been extended and many certificates expired in Q1 2022.

If nearly 13,000 registration certificates expire in the time from now to the end of December and cannot be extended, the risk of drug supply disruption will affect millions of patients, especially when Covid-19 developments are unpredictable. 

The number of newly Covid-19 infected patients is on the decrease, but it is still high (23,000 infections on April 11), and 99 percent of infections are being treated at home.

Resolution 12 needs to be strictly observed

The quick implementation of Resolution 12, including the regulation on automatically extending circulation registration certificates to the end of December 2022, is the prerequisite for enterprises to operate legally, avoid drug supply interruption, and prevent negative effects for treatment.

Analysts said there is no need to require the extension for circulation of the drugs which have been used for many years in Vietnam and globally. Their quality has been confirmed, and there is no violation in quality. 

Van Thieng