Officially apply online drug registration and declaration

On November 26, the Drug Administration of Vietnam (Ministry of Health) announced level 4 online public services in the field of drug registration and declaration and re-declaration of drug prices.

Medicine trading activities at a GPP-standard ECO pharmacy in Ho Chi Minh City. (Photo: Phuong Vy/VNA)

Speaking at the announcement ceremony, Deputy Minister of Health Le Quang Cuong said that the application of information technology and online solutions in drug price management activities aims to promote administrative procedure reform, creating maximum convenience for businesses and units in the industry. This work also maximizes the publicity of administrative procedure settlement processes of State management agencies.

Previously, in March, the Drug Administration of Vietnam announced and put into use the "Online software system for issuing reception numbers for Cosmetic Product Declaration Forms."

These two online public services will apply the digital signature of the Government Cipher Committee in returning online results.

According to Deputy Minister Cuong, with the level 4 online public service system, businesses can submit drug registration applications and declare and re-declare drug prices, pay fees and charges, monitor the processing process and receive file processing results entirely online.

For drug price declaration and re-declaration activities, the entire process of receiving, circulating, processing records and announcing and responding to businesses is carried out entirely online, with no contact between businesses and management agencies.

For drug registration activities, all technical documents, administrative documents and product information are submitted directly via the software. Enterprises 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, License for pharmaceutical production and trading, License to establish a representative office... for the Drug Administration of Vietnam to compare and submit directly or by post the drug sample.

For legal documents issued by the Vietnamese Ministry of Health, the Drug Administration of Vietnam will have a connection mechanism according to the policy of administrative procedure reform, saving time and costs for people and businesses.

The implementation of level 4 online public services in the field of drug registration and declaration and re-declaration of drug prices began in the first quarter of 2016 and was piloted for six months.

During the pilot period, to facilitate businesses and ensure that they do not disrupt operations during the initial implementation phase, businesses are still allowed to submit paper registration and drug price declaration documents as currently implemented./.

According to VIETNAM+