On January 18, 2018, the Ministry of Health (MoH) of Vietnam issued Circular No. 01/2018/TT-BYT (Circular 01) on the labeling of pharmaceuticals (referred to hereinafter as “drugs” for brevity). This circular will take effect from June 1, 2018, and will replace the current drug labeling regulations (Circular No. 06/2016/TT-BYT).
Circular 01 includes four chapters and 40 articles, providing guidelines on: (1) labels of finished product drugs and drug raw materials; (2) package inserts of finished drugs; and (3) changing the shelf life indicated on the label of finished drugs in special cases.
In light of the new circular, some notable changes will be forthcoming, including, among others:
Requirements for Package Inserts of Finished Drugs
Under current regulations, the package insert (PI) must include two separate sections, one with information for patients and the other with information for healthcare professionals. Under the new regulations, the PI will include only one section, containing general information for both patients and healthcare professionals. The simpler PI will reduce the time spent preparing the language for the PI and preparing packaging samples when registering drugs.
Package Insert Replacement after Finished Drug Is Imported into Vietnam
Under current regulations, a PI may not be replaced or supplemented after the finished drug is imported into Vietnam. Under the new Circular, this restriction is loosened, and a PI can be replaced or supplemented in Vietnam in the following circumstances:
Entities in Charge of Imported Drug Labeling
The responsible entities for drug labeling have been changed under the new circular, effectively releasing offshore manufacturers from labeling responsibility.
Circular 01 provides the following transitional provisions: