Online drug price registration and declaration officially implemented.
On November 26th, the Drug Administration of Vietnam (Ministry of Health) announced the launch of online public services at level 4 in the field of drug registration and drug price declaration/re-declaration.
Speaking at the announcement ceremony, Deputy Minister of Health Le Quang Cuong said that the implementation of information technology and online solutions in drug price management aims to accelerate administrative procedure reforms, creating maximum convenience for businesses and units in the industry. This also maximizes the transparency of administrative procedures handled by state management agencies.
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| Illustrative photo: VNA. |
Earlier in March, the Drug Administration announced and put into use the "Online software system for issuing product registration numbers for cosmetic products."
These two online public services will utilize the digital signature of the Government Cipher Committee for delivering online results.
According to Deputy Minister Cuong, with the level 4 online public service system, businesses can submit drug registration applications and declare/re-declare drug prices, pay fees and charges, track the processing progress, and receive processing results entirely online.
For drug price declaration and re-declaration activities, the entire process of receiving, circulating, processing documents, and publishing and responding to businesses is carried out entirely online, with no contact between businesses and regulatory agencies.
For drug registration, all technical and administrative documents and product information are submitted directly through the software. Businesses only submit hard copies of legal documents issued by competent authorities not under the Ministry of Health of Vietnam or the Drug Administration of Vietnam, such as CPP, GMP, Pharmaceutical Production and Business Licenses, Representative Office Establishment Licenses, etc., for the Drug Administration of Vietnam to verify and submit the drug sample directly or via mail.
For legal documents issued by the Vietnamese Ministry of Health, the Drug Administration will implement an inter-agency coordination mechanism in line with the administrative procedure reform policy, saving time and costs for citizens and businesses.
The implementation of online public services at level 4 in the field of drug registration and drug price declaration/re-declaration began in the first quarter of 2016 and was piloted for six months.
During the pilot phase, to facilitate businesses and ensure uninterrupted operations in the initial implementation period, businesses are still allowed to submit drug registration and price declaration documents in paper form, as currently stipulated.
According to Vietnam+



