From January 15, 2024: To supplement Bar code, QR code, and DataMatrix Code (DMC) to the drug labels in Vietnam?
From January 15, 2024: To supplement Bar code, QR code, and DataMatrix Code (DMC) to the drug labels in Vietnam?
Currently, there are no regulations on drug labeling that drug labels must have a Bar code, QR code, and DataMatrix Code (DMC).
The Minister of Health has just issued Circular 23/2023/TT-BYT on amendments to Circular 01/2018/TT-BYT prescribing labeling and package inserts of drugs and medicinal materials.
The issue of other contents shown on drug labels is specified in Clause 2, Article 35 of Circular 01/2018/TT-BYT as follows:
In addition to the compulsory information prescribed in this Circular and before selling drugs on the market, the responsible entity may write other information on the drug label and/or package insert which has been approved by a regulatory authority without giving a notification and obtaining the approval from a regulatory authority provided that it must satisfy the requirements in Clause 3 of this Article. In such case, the responsible entity shall ensure the accuracy of additional information. To be specific:
a) Affix or alter anti-fraud stamps as well as other security warnings and anti-counterfeit contents on drug labels to help fight against counterfeit products or recognize their products;
b) Change the form or color of the package insert; the size of the secondary package label or the primary package label;
c) Add or alter the telephone number, zip code, web address or email address of any relevant entity responsible for the drug or of the brand owner;
d) Add or alter the symbol ® behind the drug name or behind the company’s name or logo; change logo of any relevant entity responsible for the drug;
dd) Change the position of the registration number or import license number, the position of the secondary label, or the position of batch number, expiry date or manufacturing date on the label;
e) Add information in another language which is translated from the information in Vietnamese language as approved by the Ministry of Health according to the application for drug registration or the application for the license to import drugs without registration number.
Accordingly, the addition of Bar code, QR code, DataMatrix Code (DMC) is added to the above regulations as follows:
Add point g after point e, clause 2, Article 35 as follows:
“g) Bar code, QR code, DataMatrix Code (DMC) or another appropriate code shall be added to the label in order to serve the tracking of electronic instructions for use and electronic labeling of goods according to the roadmap set by the Minister of Health of Vietnam.”
Thus, Bar code, QR code, DataMatrix Code (DMC) or another appropriate code shall be added to the label in order to serve the tracking of electronic instructions for use and electronic labeling of goods according to the roadmap set by the competent authority. The competent authority approves when the provisions in Clause 3, Article 35 of Circular 01/2018/TT-BYT are met, no notification is required and approval from the competent authority is not required, but the facility is responsible for recording the label is solely responsible for the accuracy of the additional information.
From January 15, 2024: To supplement Bar code, QR code, and DataMatrix Code (DMC) to the drug labels in Vietnam?
How are the responsibilities for labeling drugs, medicinal ingredients and drug use instructions regulated?
Pursuant to the provisions of Article 6 of Circular 01/2018/TT-BYT, the responsibility for labeling of drugs and medicinal ingredients and package inserts is regulated as follows:
- Entities responsible for labeling of drugs or medicinal ingredients, including secondary labels and package inserts, must ensure that the information on labels must be truthful, clear and accurate, and reflect the nature of drugs or medicinal ingredients.
- With regard to drugs or medicinal ingredients manufactured in Vietnam:
+ The manufacturer and/or registrant are responsible for labeling and package inserts of drugs or medicinal ingredients manufactured and/or registered;
+ Health facilities that are allowed to prepare traditional drugs in accordance with regulations in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy and health facilities that are allowed to produce and prepare drugs in accordance with regulations in Clause 2 and Clause 3 Article 85 of the Law on Pharmacy are responsible for labeling of their drugs prepared or produced;
+ Drugstores that prepare prescription drugs and sell them in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy are responsible for labeling of their prescription drugs prepared.
- With regard to imported drugs or medicinal ingredients:
+ The importer and/or registrant of drugs are responsible for labeling and package inserts of drugs having registration numbers;
+ The importer and/or registrant of medicinal ingredients are responsible for labeling of imported medicinal ingredients;
+ The importer is responsible for labeling and package inserts of imported drugs without registration numbers.
- With regard to medicinal ingredients divided into smaller package units in course of wholesale or retail: Pharmacy business establishments that divide drugs into smaller package units are responsible for affixing secondary labels in conformity with regulations in Clause 2 and Clause 3 Article 7 of Circular 01/2018/TT-BYT.
In what cases do drugs not have to be registered before being circulated in Vietnam?
Pursuant to the provisions of Clause 1, Article 54 of the Law on Pharmacy 2016, drugs must be registered before free sale in Vietnam, except for:
- Drugs prepared by prescription at drugstores as specified in Point b Clause 1 Article 47 the Law on Pharmacy 2016; drugs manufactured or prepared at health facilities as specified in Article 85 the Law on Pharmacy 2016;
- Imported drugs specified in Clause 2 Article 60 the Law on Pharmacy 2016;
- Traditional drugs specified in Clause 1 and Clause 2 Article 70 the Law on Pharmacy 2016.
Circular 23/2023/TT-BYT takes effect from January 15, 2024.
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