Circular No. 23/2023/TT-BYT amends and supplements certain provisions of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health, concerning drug labeling, raw materials for drugs, and the drug user guide.

CIRCULAR

Amending and supplementing some articles of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health on labeling of drugs, raw materials for drugs, and drug user instructions

On the basis of The Drug Law No. 105/2016/QH13 dated April 6, 2016;

Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling;

Decree No. Decision No. 111/2021/NĐ-CP dated December 9, 2021 of the Government amending and supplementing certain provisions of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling;

Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law;

Decree No. Decision No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions under the management of the Ministry of Health;

Decree No. Decision No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department.

The Minister of Health issues this Circular to amend and supplement some articles of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health on labeling of drugs, raw materials for drugs, and drug user instructions.

Article 1. Amending and supplementing some articles of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health on labeling of drugs, raw materials for drugs, and drug user instructions

1. Supplement Clause 3 and Clause 4 after Clause 2, Article 3 as follows:

“3. The label and user instruction sheet of radioactive drugs do not necessarily have to be attached to the commercial packaging but can be provided to treatment facilities along with the drug delivery record or affixed to the packaging used for storage, transportation, and preservation of the drug.

4. For imported drugs that have been granted circulation registration certificates in emergency situations for national defense, security, disease prevention and control, disaster relief, the user instruction sheet may be affixed to the outer packaging.”

2. Amend and supplement Clause 1, Article 5 as follows:

“1. Imported drugs and raw materials for drugs whose original labels do not fully display all required information compared to the labels approved by the Ministry of Health, the importer may supplement the Vietnamese label after customs clearance. The supplementary label must comply with the approved drug label and must be completed before the drug is put into circulation and must retain the original label.”

3. Amending and supplementing Clause 2 of Article 5 as follows:

“2. In the following cases, the Vietnamese user instruction sheet may be supplemented or replaced after customs clearance:

a) Imported drugs that already have a circulation registration certificate in Vietnam and have a Vietnamese user instruction sheet in the commercial packaging but have not updated the content of the user instruction sheet according to the requirements of the Ministry of Health, except for drugs that do not require a user instruction sheet as specified in Points a, b, c, and d of Clause 1, Article 13 of this Circular;

b) Imported drugs without a circulation registration certificate in Vietnam and without a Vietnamese user instruction sheet in the commercial packaging, except for drugs that do not require a user instruction sheet as specified in Points a, b, c, d, and d of Clause 1, Article 13 of this Circular.

c) Imported drugs that have been granted circulation registration certificates in emergency situations for national defense, security, disease prevention and control, disaster relief, and do not have a Vietnamese user instruction sheet in the commercial packaging.”

4. Amending and supplementing Point b of Clause 3, Article 5 as follows:

“b) Supplementing or replacing the Vietnamese user instruction sheet shall be carried out at the secondary packaging unit (secondary packaging) of the entity that meets the Good Manufacturing Practice (GMP) principles and standards according to the scope of the Certificate of Compliance for Pharmaceutical Business Conditions;

If the user instruction sheet is affixed to the direct contact packaging of the drug as stipulated in Clause 2, Article 3 of this Circular, the supplementation or replacement of the user instruction sheet shall be carried out at the packaging unit of the entity that meets the GMP principles and standards or at the drug storage warehouse that meets the Good Storage Practice (GSP) principles and standards before the drug is put into circulation.”

5. Supplementing Point d after Point c of Clause 3, Article 5 as follows:

“d) The supplementary or replaced Vietnamese user instruction sheet must be consistent with the user instruction sheet approved by the Ministry of Health and must be completed before the drug is put into circulation.”

6. Amending and supplementing Point e of Clause 3, Article 14 as follows:

“e) It shall not be identical or similar to the name of drugs that have been granted circulation registration certificates by other registering entities, except for drugs specified in Point a of Clause 1, Article 6 and Point a of Clause 1, Article 10 of Circular No. 16/2023/TT-BYT dated August 15, 2023, issued by the Minister of Health on the registration for circulation of processed drugs and technology transfer drugs in Vietnam;”

7. Abolishing the provision at Item 6 of Point c of Clause 1, Article 15.

8. Amending Item 1 of Point a of Clause 1, Article 16 as follows:

“Fully listing the name and quantity, weight, or concentration of each active ingredient and herbal component in the drug formula, semi-finished product for the smallest dosage unit or the smallest packaging unit. For liquid and semi-solid drugs with multi-dose packaging: The active ingredient content is expressed as a percentage (% weight/weight or weight/volume).”

9. Replacing the phrase "In case the original label records the production date, expiration date, batch number in a foreign language" in Point a of Clause 3, Article 29 with the phrase "In case the original label records the production date, expiration date, batch number".

10. Amending Item 2 of Point c of Clause 3, Article 29 as follows:

“- Expiration date after opening the primary packaging for the first time for undosed forms such as eye drops, nasal sprays, ear drops, multiple-use creams, gels, and multi-dose liquid oral medications;”

11. Supplementing Point g after Point e of Clause 2, Article 35 as follows:

“g) Adding barcode, QR code, DataMatrix Code (DMC), or suitable types of codes on the drug label to enable electronic retrieval of drug user instructions and to implement electronic labeling of goods according to the roadmap set by the Minister of Health.”

12. Amending and supplementing Clause 3, Article 38 as follows:

"3. The entities registering drugs and manufacturing drugs have the responsibility to update and supplement the contents in the drug usage guide for generic drugs in accordance with the usage guidance contents of brand-name origin drugs listed in the Essential Medicine List, as published on the electronic information website of the Drug Administration Department, as follows:

a) The drug usage guide of generic drugs (having the same active ingredient, concentration, dosage, formulation, route of administration as the brand-name origin drug) must ensure consistency with the usage guidance of the brand-name origin drug. For other information in the drug usage guide of generic drugs such as expiration date, excipient components, quality standards, bioavailability parameters, pharmacokinetic data, adverse drug reactions, clinical study results may differ from those of the brand-name origin drug. Information about adverse drug reactions in the drug usage guide of generic drugs shall not be less than that of the brand-name origin drug, except for adverse reactions related to excipients which are not present in the composition of the generic drug;

b) Within twelve months from the date the Drug Administration Department publishes and posts the drug usage guide of brand-name origin drugs on its electronic information website according to Clause 1 and Clause 2 of this Article, the entity registering drugs and the manufacturer of generic drugs have the responsibility to self-review and update the label and usage guide content in accordance with the drug usage guide of brand-name origin drugs for the information specified in Clause 2 of this Article, without the need to notify the Ministry of Health, except in cases where the Ministry of Health has other requirements."

Article 2. Effective Date

This Circular takes effect from January 15, 2024.

Article 3. Transitional Provisions

1. Drugs and raw materials for drugs produced or imported before January 1, 2025 can continue to circulate and use labels and drug usage guides approved by the Ministry of Health until the expiration date of the drug batch or raw material batch.

2. Labels and drug usage guides in applications for issuance, extension, change, or addition to the registration for circulation submitted to the receiving agency before the effective date of this Circular but still under processing shall be applied according to the regulations at the time of submission, except in cases where the registering entity voluntarily implements the provisions of this Circular from the effective date of the Circular.

By no later than January 1, 2025, labels and drug usage guides must comply with the provisions of this Circular before putting the drug on the market.

Article 4. Responsibilities for Implementation

1. The Drug Administration Department shall be responsible for:

a) Develop regulations and implementation timelines for labeling goods electronically for drugs circulating on the market to be promulgated by the Minister of Health;

b) Organize guidance and implementation of the provisions of this Circular.

2. The Director of the Ministry's Office; the Director of the Drug Administration Department; the Inspector General of the Ministry; the heads of units under and affiliated with the Ministry of Health; the Directors of Provincial Health Departments; the heads of health sector facilities; organizations and individuals engaged in drug registration activities are responsible for implementing this Circular.

3. During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.