According to the Drug Administration of Vietnam (Ministry of Health), of the nearly 500 drugs and pharmaceutical ingredients whose circulation registration certificates were newly granted or extended this time, 325 domestically produced drugs were newly granted; 130 drugs and pharmaceutical ingredients were extended; the rest are drugs in the bioequivalent list.
Of the drugs and pharmaceutical ingredients that are newly granted or renewed, more than 90% of the drugs and pharmaceutical ingredients are newly granted or renewed within 5 years.
The Drug Administration of Vietnam requires drug manufacturing and registration establishments to be responsible for: Producing drugs in accordance with the records and documents registered with the Ministry of Health and must print or affix the registration number issued by the Vietnamese Ministry of Health on the drug label.
Specially controlled drugs may only be produced and put into circulation when there is a Certificate of eligibility for pharmaceutical business. The scope of business of specially controlled drugs is suitable for the scope of operation of the facility, meeting the provisions of Clause 5, Article 143 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law on Pharmacy.
At the same time, update drug quality standards according to regulations on drug quality and drug ingredients.
The Drug Administration of Vietnam requires drug manufacturers and drug registration establishments to update drug labels and drug instructions according to regulations on drug labeling, drug ingredients and drug instructions within 6 months from the date of signing and promulgating this Decision, in the form of changing and supplementing drug circulation registration certificates.
Coordinate with treatment facilities to comply with current regulations on prescription drugs, monitor safety, effectiveness, and adverse effects of drugs on Vietnamese people, and synthesize and report according to regulations.
The drug registration facility must ensure that the operating conditions are maintained during the validity period of the drug and drug ingredient registration certificate. In case the operating conditions are no longer met, the registration facility must be responsible for changing the registration facility according to regulations within 30 days from the date the registration facility no longer meets the operating conditions.
Drug manufacturing facilities must ensure the operating conditions of the manufacturing facility during the validity period of the drug and drug ingredient circulation registration certificate.
Previously, the Drug Administration also extended the drug circulation registration certificate according to Resolution 80 of the National Assembly for nearly 400 types of drugs and pharmaceutical ingredients to serve the drug use needs of the people and medical examination and treatment facilities...
According to the Drug Administration of Vietnam, up to now, the Department has issued new and renewed circulation registration certificates according to the 2016 Pharmacy Law and Resolution 80 of the National Assembly for over 14,000 drugs and pharmaceutical ingredients. Thereby, it has maintained over 23,000 drugs with valid circulation registration certificates, ensuring the supply of drugs.
At the same time, deploy solutions to ensure vaccine procurement; develop a list and mechanism for reserving and purchasing drugs at risk of shortage at medical examination and treatment facilities...
