Circular 23/2023/TT-BYT amend Circular 01/2018/TT-BYT providing for the labeling of drugs and drug materials and package inserts

CIRCULAR

Amending and supplementing a number of articles of the Minister of Health’s Circular No. 01/2018/TT-BYT dated January 18, 2018, providing for the labeling of drugs and drug materials and package inserts

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Pursuant to the Law on Pharmacy dated April 6, 2016;

Pursuant to the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling;

Pursuant to the Government’s Decree No. 111/2021/ND-CP dated December 9, 2021, amending and supplementing a number of articles of the Government’s Decree No. 43/2017/ND-CP of April 14, 2017, on goods labeling;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of regulations related to business investment conditions under the state management of the Ministry of Health;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam;

The Minister of Health promulgates the Circular amending and supplementing a number of articles of the Ministry of Health’s Circular No. 01/2018/TT-BYT dated January 18, 2018, providing for the labeling of drugs and drug materials and package inserts.

Article 1. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 01/2018/TT-BYT dated January 18, 2018, providing for the labeling of drugs and drug materials and package inserts

1. To add Clause 3 and Clause 4 after Clause 2 Article 3 as follows:

“3. The labels and package inserts of radioactive drugs are not required to accompany the commercial packagings but may be provided to the treatment facilities with the drug delivery dossiers or affixed to the packagings for the purpose of storing, transporting and preserving radioactive drugs.

4. For the imported drugs are granted the circulation registration certificates in case of emergency for national defense, security, disease prevention and control, overcoming the consequences of natural disasters and catastrophes, the package inserts may be affixed to the exterior packagings.”

2. To amend and supplement Clause 1 Article 5 as follows:

“1. If the original labels of drugs or drug materials imported into Vietnam do not contain full information compared to the labels approved by the Ministry of Health, the importer must add the supplementary labels in Vietnamese language after customs clearance. Additional supplementary labels must be consistent with the labels approved by the Ministry of Health and must be added before drugs are sold on the market while the original labels remain unchanged.”

3. To amend and supplement Clause 2 Article 5 as follows:

“2. In the following cases, package inserts in Vietnamese language are supplemented or replaced after customs clearance:

a) Imported drugs have the circulation registration certificates in Vietnam but the content of the package inserts in Vietnamese language of the commercial packagings has not yet been updated as regulated by the Ministry of Health, except for the cases where the drug package inserts are not required as prescribed at Points a, b, c and d Clause 1 Article 13 herein;

b) Imported drugs do not have the circulation registration certificates in Vietnam and the package inserts in Vietnamese language of the commercial packagings are unavailable, except for the cases where the drug package inserts are not required as prescribed at Points a, b, c, d and dd Clause 1 Article 13 herein;

c) Imported drugs have been granted the circulation registration certificates by the Ministry of Health in case of emergency for national defense, security, disease prevention and control, overcoming the consequences of natural disasters and catastrophes but the package inserts in Vietnamese language of the commercial packagings are unavailable.”

4. To amend and supplement Point b Clause 3 Article 5 as follows:

“b) Package inserts in Vietnamese language are added or replaced at the secondary packaging divisions of facilities that attain principles and standards of Good Manufacturing practices of drugs (GMP) in conformity with the scope of the Certificate of eligibility for pharmacy business;

In case the package inserts are affixed to the interior packagings of drugs according to Clause 2 Article 3 of this Circular, the addition or replacement of the package inserts shall be performed at the packaging divisions of facilities that attain principles and standards of Good Manufacturing Practices of drugs (GMP) or warehouses for preserving drugs and drug materials that attain the principles and standards of Good Storage Practices of drugs (GSP) before drugs are sold on the market.”

5. To add Point d after Point c Clause 3 Article 5 as follows:

“d) Additional or replacement use instructions in Vietnamese language must be compliant with those approved by the Ministry of Health and must be implemented before drugs are sold on the market.”

6. To amend and supplement Point e Clause 3 Article 14 as follows:

“e) Be identical or similar to the name of drugs that have been granted the circulation registration certificates of another facilities, except for drugs specified at Point a Clause 1 Article 6 and Point a Clause 1 Article 10 of the Minister of Health’s Circular No. 16/2023/TT-BYT dated August 15, 2023, specifying the marketing authorization of drugs manufactured through contract manufacturing and drugs manufactured through technology transfer in Vietnam;”

7. To abolish the provisions of Item 6 Point c Clause 1 Article 15.

8. To amend Item 1 Point a Clause 1 Article 16 as follows:

“The names, contents and amount or concentrations of each pharmaceutical ingredient, medicinal material in the recipes of drugs, semi-finished drugs for the smallest dose or package. For liquid and semi-solid drugs with multi-dose packagings: Content of ingredient is recorded in % concentration (mass/mass or mass/volume).”

9. To replace the phrase “In case the manufacturing date, expiry date and batch number are written on an original label in a foreign language” at Point a Clause 3 Article 29 with the phrase “In case the manufacturing date, expiry date and batch number are written on an original label”.

10. To amend Item 2 Point c Clause 3 Article 29 as follows:

“- The shelf life after opening the interior packagings for the first time for drugs without divided dose such as eye drops, nose drops, ear drops, ointment, multi-use gel and orally administered multi-dose liquid drugs;”

11. To add Point g after Point e Clause 2 Article 35 as follows:

“g) Adding bar codes, QR codes, DataMatrix Codes (DMC) or appropriate codes on the labels of drugs to retrieve the electronic use instructions and writing the labels of goods by an electronic method according to the roadmap regulated by the Minister of Health.”

12. To amend and supplement Clause 3 Article 38 as follows:

“3. Registrants and manufacturers shall update and supplement information on package inserts of generic drugs in conformity with use instructions on the List of corresponding brand name specifics published on the website of the Drug Administration of Vietnam as follows:

a) Package inserts of generic drugs (has the same active ingredient, concentration, content, dosage form, and route of administration as the brand name specific) must be compliant with use instructions of the corresponding brand name specifics. For other information in the package inserts of generic drugs such as: expiry dates, compositions of excipients, quality standards, bioavailability, pharmacokinetics, unwanted effects and clinical test results may differ from brand name specifics. Information about unwanted effects in the package inserts of generic drugs must not be less than that of the corresponding brand name specifics, except for unwanted effects of the brand name specifics related to the compositions of excipients that are not included in the generic drugs;

b) Within 12 months from the date on which the Drug Administration of Vietnam announces and publishes package inserts of brand name specifics on its website under Clause 1, Clause 2 of this Article, registrants and manufacturers of generic drugs must review and update information on labels and use instructions in accordance with package inserts of brand name specifics for information mentioned in Clause 2 of this Article without giving notification to the Ministry of Health, unless otherwise requested by the Ministry of Health.”

Article 2. Effect

This Circular takes effect from January 15, 2024.

Article 3. Transitional provisions

1. Drugs and drug materials that are manufactured or imported before January 1, 2025 may continue to be circulated and continue to use samples of labels and package inserts approved by the Ministry of Health until the expiration date of the drugs and drug materials.

2. Labels and package inserts in dossiers for grant, extension, change, or supplementation of circulation registration certificates already submitted to the dossier-receiving agencies before the effective date of this Circular, which are in the process of resolving, shall be applied according to regulations at the time of dossier submission, except for the cases the registrants voluntarily comply with the provisions of this Circular from its effective date.

By January 1, 2025 at the latest, drug labels and package inserts must satisfy the regulations of this Circular before the drugs are sold on the market.

Article 4. Responsibility for implementation

1. The Drug Administration of Vietnam shall:

a) Develop regulations and roadmaps for electronical labeling of drugs sold on the market, and submit them to the Minister of Health for promulgation;

b) Provide guidance and implement this Circular.

2. The Chief of the Ministry Office, the Director of the Drug Administration of Vietnam, the Chief of the Ministry Inspectorate, Heads of affiliated units of the Ministry of Health, Directors of Departments of Health of provinces and centrally-run cities, Heads of healthcare facilities, organizations and individuals operating in the drug registration sector shall implement this Circular.

3. Any difficulties arising in the course of implementation should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement./.