New Provisions on Drug and Drug Ingredient Labeling Regulations

Accordingly, certain new terms adjusted in the Pharmacy Law have been amended and supplemented, such as: Traditional medicine replacing Eastern medicine, herbal medicine replacing herbal-derived medicine; supplementing and stipulating the labeling content of compounded drugs prescribed and sold at pharmacies, and drugs compounded and manufactured in medical examination and treatment facilities to unify the labeling contents of circulating drugs on the market without requiring registration for circulation permits.

The Drug Administration Department believes that the labeling regulations for drugs produced and compounded in hospitals contribute positively to providing complete information on drug use for healthcare staff and help patients understand the benefits and risks of drugs, adhere to treatment guidelines appropriately, and ensure the rational and safe use of drugs.

Noting some identification signs on labels and drug instruction leaflets for certain types of drugs and raw materials for drugs such as: poisonous drugs, radioactive drugs, poisonous raw materials, radioactive raw materials, poisonous herbal medicine. Special caution regarding controlled raw materials must be printed in bold within a frame and placed on the main face of the label with the ingredient's name; cautions on poisonous drugs, radioactive drugs must be printed in bold capital letters on labels and drug instruction leaflets.

The regulation requiring labeling of caution signs for controlled raw materials, poisonous drugs, and radioactive drugs is aimed at warning about the risk of drug misuse, misidentification of drug raw materials, special storage, transportation, and usage precautions for patients, and providing complete information for healthcare staff during prescribing and instructions for patient use to be safe and effective.

Previously, the principles for naming commercial drugs were regulated in the drug registration circular. However, this content has been supplemented and specified in the labeling circular, wherein it has been amended with the regulation "drugs must not have different names if they share all the following criteria: active ingredient, herbal medicine, dosage form, route of administration, concentration, dosage, and manufacturer."

This new regulation addresses the issue of businesses using multiple brand names for drugs that share the same criteria in terms of dosage form, route of administration, concentration, dosage, and manufacturer but have different formulations, only differing in excipient composition.

To facilitate the management, inspection, and monitoring of pharmaceutical business activities related to the replacement and supplementation of Vietnamese language leaflets in Vietnam, the circular has specifically added more cases where supplemental labels, replacement, and supplementation of Vietnamese language leaflets in Vietnam are mandatory, and requires establishments to report to the Ministry of Health within one month from the completion of the replacement or supplementation of drug instruction leaflets in Vietnam.

Currently, drugs circulating on the market in commercial packaging must have Vietnamese language instruction leaflets, which are divided into two parts: instructions for healthcare staff and instructions for patients. These two parts contain a lot of duplication, and the requirement of having two parts in the packaging increases the size of the drug box and raises production costs due to additional printing. To address these issues, the new Circular has supplemented and removed the regulations requiring the drug instruction leaflet to comprise the two aforementioned parts, eliminating the patient use instructions.

The Circular also adds regulations on the publishing time for instruction leaflets of original specialty drugs and reference biologics that have been granted circulation registration certificates in Vietnam on the Drug Administration Department's Website. At the same time, it regulates the responsibility of manufacturers and registrars of generic drugs and similar biologics to refer to the instruction leaflets while preparing or updating the content of instruction leaflets for their generic drugs and similar biologics to align with those of the original specialty drugs and corresponding reference biologics in terms of concentration, dosage, active ingredient, dosage form, and route of administration during their circulation.

This regulation aims to ensure and gradually unify and synchronize the drug usage information for approved generic drugs and similar biologics in Vietnam in accordance with the drug usage information of corresponding original specialty drugs and reference biologics based on clinical dossiers and standardized, approved, and licensed instruction leaflets for these drugs in Vietnam.

Additionally, to facilitate and enhance the responsibility of enterprises, the circular specifically provides for several cases where manufacturers, registrars, and importers of drugs are permitted to include additional content on labels and instruction leaflets beyond the mandatory content required by the Circular. These additional contents do not require notification or approval from the Ministry of Health, although the establishment must take responsibility for the accuracy of the additional information.

Source: Dan Tri Vietnam Forum

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