NEW PROVISIONS ON LABELING AND PACKAGE INSERTS OF DRUGS
Beside requirement about labeling and package inserts of drugs and medicinal ingredients, Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health also prescribed about changing expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.
Accordingly, the package insert is an integral part of the drug label and contained in the secondary package. If a drug does not have the secondary package, the package insert must be printed or affixed on the primary package.
All information about the influence of drugs on pregnant women shall be provided. If such information is not available, the text "There is no controlled data in human pregnancy. The drug is only recommended for use during pregnancy when benefit outweighs risk" must be specified. Concurrently, all the reactions of the drug with other drugs and other reactions (e.g. with alcohol, foods, etc.) that may affect the effectiveness of the drug must be specified.
With regards to drugs on the list of State secrets and family remedies that allowed to omit certain herbal ingredients and contents or weights thereof, the package inserts must have the text "The drug recipients is the State secret" or "The drug recipients is the traditional secret".
This Circular takes effect on June 01, 2018.
