Thông tư 23/2023/TT-BYT sửa đổi, bổ sung một số điều tại Thông tư 01/2018/TT-BYT quy định ghi nhãn thuốc, nguyên liệu làm thuốc và tờ hướng dẫn sử dụng thuốc

CIRCULAR

AMENDMENTS TO CIRCULAR NO. 01/2018/TT-BYT DATED JANUARY 18, 2018 OF MINISTER OF HEALTH OF VIETNAM PRESCRIBING LABELING AND PACKAGE INSERTS OF DRUGS AND MEDICINAL MATERIALS

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

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

Pursuant to the Government’s Decree No. 111/2021/ND-CP dated December 09, 2021 providing amendments to the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017 on good labeling;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to some articles related to business conditions under state management of the Ministry of Health of Vietnam;

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

At the request of Director General of Drug Administration of Vietnam,

The Minister of Health of Vietnam promulgates a Circular providing amendments to Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of Vietnam prescribing labeling and package inserts of drugs and medicinal materials.

Article 1. Amendments to Circular No. 01/2018/TT-BYT dated January 18, 2018 of Minister of Health of Vietnam 

1. Clause 3 and Clause 4 are added following Clause 2 Article 3 as follows:

“3. Labels and package inserts of radioactive drugs are not required to be accompanied with their commercial packages but can be accompanied with drug delivery records sent to treatment facilities or stuck or affixed to packages used for storage or transport of drugs.

4. Package inserts of imported drugs which have been granted marketing authorization for national defense and security, epidemic prevention and control, disaster or calamity recovery purpose may be affixed to their secondary packages.”

2. Clause 1 Article 5 is amended as follows:

“1. If the original label of a drug or medicinal material imported into Vietnam does not contain sufficient compulsory information as approved by the Ministry of Health, the importer shall be allowed to affix the secondary label in Vietnamese language after the grant of customs clearance. Such secondary label must contain appropriate information as approved by the Ministry of Health of Vietnam and be affixed before the drug is placed on the market while the original label is kept unchanged.”

3. Clause 2 Article 5 is amended as follows:

“2. Importers shall be granted customs clearance in order to add or replace package inserts in Vietnamese language in Vietnam in the following cases:

a) Imported drugs which have been granted the marketing authorization in Vietnam and have the package inserts in Vietnamese language contained in their commercial packages but have been not yet updated with compulsory information as regulated the Ministry of Health of Vietnam, except the cases where package inserts are exempted according to provisions of Points a, b, c and d Clause 1 Article 13 hereof;

b) Imported drugs which are not yet granted marketing authorization in Vietnam and do not have the package inserts in Vietnamese language contained in their commercial packages, except the cases where package inserts are exempted according to provisions of Points a, b, c, d and dd Clause 1 Article 13 hereof.

c) Imported drugs which have been granted marketing authorization by the Ministry of Health of Vietnam for national defense and security, epidemic prevention and control, disaster or calamity recovery purpose and do not have the package inserts in Vietnamese language contained in their commercial packages.”

4. Point b Clause 3 Article 5 is amended as follows:

“b) Package inserts in Vietnamese language shall be added or replaced by the secondary packaging division of a facility that has GMP certificate in conformity with the scope of the Certificate of eligibility for pharmacy business;

Package inserts which have been affixed to primary packages of drugs as prescribed in Clause 2 Article 3 of this Circular may be added or replaced by the packaging division of a facility that has GMP certificate or the storage facility that has GSP certificate before drugs are placed on the market.”

5. Point d is added following Point c Clause 3 Article 5 as follows:

“d) The package inserts in Vietnamese language to be added or replaced must be conformable with the package insert approved by the Ministry of Health of Vietnam, and such addition or replacement must be completed before drugs are placed on the market.”

6. Point e Clause 3 Article 14 is amended as follows:

“e) The trade name of drug should not be identical or similar to the name of drugs granted marketing authorization of another facility, except drugs specified in Point a Clause 1 Article 6 and Point a Clause 1 Article 10 of the Circular No. 16/2023/TT-BYT dated August 15, 2023 of the Minister of Health of Vietnam;”

7. Paragraph 6 Point c Clause 1 Article 15 is abrogated.

8. Paragraph 1 Point a Clause 1 Article 16 is amended as follows:

“The names of active ingredients or herbal ingredients and concentrations or contents thereof in a smallest single dose or packaging unit of drugs or semi-finished drugs shall be specified. Regarding multi-dose liquid or semi-solid drugs, the content of active ingredients shall be expressed as the weight/weight or weight/volume concentration (%).”

9. The phrase “Trường hợp nhãn gốc ghi ngày sản xuất, hạn dùng, số lô sản xuất bằng tiếng nước ngoài” (“Where the manufacturing date, expiry date and batch number are written on the original label in a foreign language”) in Point a Clause 3 Article 29 is replaced with the phrase “Trường hợp nhãn gốc ghi ngày sản xuất, hạn dùng, số lô sản xuất” (“Where the manufacturing date, expiry date and batch number are written on the original label”).

10. Paragraph 2 Point c Clause 3 Article 29 is amended as follows:

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

11. Point g is added following 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."

12. Clause 3 Article 38 is amended as follows:

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

a) The package insert of a generic drug (which has the same active ingredients, concentration/content, dosage form and administration route as the original brand-name drug) must be conformable with that of the corresponding original brand-name drug. Other information on the package insert of the generic drug, including: expiry date, excipients, quality standards, bioavailability, pharmacokinetics, adverse effects and clinical test results, may be different from that on the original brand-name drug. The package insert of the generic drug must provide more information on adverse effects than that of the corresponding original brand-name drug, except adverse effects of the original brand-name drug related to an excipient which is not included in the generic drug;

b) Within 12 months from the date on which the Drug Administration of Vietnam announced and published package inserts of original brand-name drugs on its website as prescribed in Clause 1, Clause 2 of this Article, registrants and manufacturers of generic drugs shall review and update information on labels and package inserts of their products in conformity with package inserts of original brand-name drugs in terms of the information mentioned in Clause 2 of this Article without giving notification to the Ministry of Health of Vietnam, unless otherwise requested by the Ministry of Health of Vietnam.”

Article 2. Effect

This Circular comes into force from January 15, 2024.

Article 3. Transition

1. Drugs or medicinal materials manufactured or imported before January 01, 2025 shall continue to be placed on the market with the labels and package inserts which have been approved by the Ministry of Health of Vietnam until the expiry date of the drug or medicinal material batch.

2. Labels and package inserts included in applications for issuance, renewal or revision of marketing authorization which have been submitted to competent authorities before the effective date of this Circular and are under consideration may comply with regulations of law in force at the submission date, unless the registrant voluntarily applies this Circular from the effective date thereof.

By January 01, 2025, labels and package inserts must meet the requirements laid down in this Circular before drugs are placed on the market.

Article 4. Responsibility for implementation

1. The Drug Administration of Vietnam shall:

a) Develop and submit regulations and roadmap for electronic labeling of drugs placed on the market to the Minister of Health of Vietnam for promulgation;

b) Provide guidelines for and implement this Circular.

2. The Chief of the Ministry Office; the Director of the Drug Administration of Vietnam; the Ministry’s Chief Inspector; heads of units/departments of and affiliated to the Ministry of Health of Vietnam; Directors of provincial Departments of Health; heads of specialized health authorities; relevant organizations and individuals involved in registration of drugs are responsible for the implementation of this Circular.

3. Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health of Vietnam (via the Drug Administration of Vietnam) for consideration./.