Circular No. 14/2000/TT-BYT guiding the implementation of Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister regarding the labeling of vaccine and immunological products.

CIRCULAR

Guidelines for Implementing Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government on Labeling of Vaccine and Immunological Products

dated August 30, 1999, of the Prime Minister regarding the labeling of vaccine and immunobiological products

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Pursuant to Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government promulgating the Regulations on Labeling of Goods Circulating Domestically and Exported and Imported Goods, and Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade guiding the implementation of Decision No. 178/1999/QĐ-TTg of the Government, the Ministry of Health guides the labeling of vaccine and immunological products as follows:

The labeling of vaccine and immunological products must be carried out in accordance with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government promulgating the Regulations on Labeling of Goods Circulating Domestically and Exported and Imported Goods; Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade guiding the implementation of Decision No. 178/1999/QĐ-TTg of the Government, and the following provisions:

I. LABEL CONTENTS:

A. REQUIRED CONTENTS:

1. Name of vaccine, immunological product

In accordance with Article 6 of the Regulations on Labeling of Goods Circulating Domestically and Exported and Imported Goods issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government.

2. Name and address of the production facility:

a. The name of the production facility is the full name of the production facility recorded in the relevant legal documents related to the establishment of that production facility. The trade name may also be added but its size must be smaller and not bolder than the full name.

b. If the vaccine, immunological product is completely produced at one production facility, the name of the production facility is the name of that manufacturer.

c. If the vaccine, immunological product is packaged from semi-finished products made by other manufacturers, the name and address of the packaging facility and the name and address of the production facility producing the semi-finished products must be indicated.

d. Address includes: house number, street (village, hamlet), ward (commune), district (county, city), city (province), country name.

3. Name and address of the trader responsible for the goods:

In accordance with Article 7 of the Regulations, the name and address of the trader responsible for the goods are the name and address of the trader registered for business activities. The address includes: house number, street (village, hamlet), ward (commune), district (county, city), city (province).

4. Composition of the vaccine, immunological product:

a. Fully list the composition of the vaccine, immunological product.

b. Units of measurement: in accordance with Table 1, Section 3, Part A, Chapter II of Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade.

5. Packaging specifications (quantity of vaccine, immunological product) and form of the vaccine, immunological product:

a. The packaging specification of the vaccine, immunological product is the quantity or volume of the vaccine, immunological product in the commercial package.

b. The preparation form of the vaccine, immunological product is recorded according to the form in the package containing the vaccine, immunological product (for example: lyophilized form, solution form, powder form...).

6. Registration number, batch number, date of manufacture, expiration date, storage conditions and period, applicable standards:

a. The registration number is issued by the Ministry of Health of Vietnam (Preventive Medicine Department) for the vaccine, immunological product to certify that the vaccine, immunological product has been registered for circulation in Vietnam.

b. Batch number is defined by the production facility.

c. Date of manufacture (time of completion of production of the vaccine, immunological product) and expiration date (period beyond which the vaccine, immunological product is not allowed to circulate and cannot be used): recorded in accordance with Section 6, Part A, Chapter II of Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade.

d. Storage conditions: are mandatory requirements regarding the environment to prevent changes in efficacy, safety, and stability of the vaccine, immunological product.

e. Applicable standards: are quality standards applied by the manufacturer to the vaccine, immunological product.

7. Indications, method of use, contraindications, adverse effects (if any):

a. The indication for use on the label must be consistent with the effect of the vaccine, immunological product.

b. Method of use: clearly record the route of administration, dosage, dose division, time, frequency of use...

c. Contraindications: if there are contraindications, they must be clearly stated for cases requiring contraindication and cases requiring caution.

d. Adverse effects: clearly record the adverse effects, unwanted effects of the vaccine, immunological product and measures for handling.

In this section, only essential information is required to be recorded.

B. NON-REQUIRED CONTENTS:

In addition to the contents that must be displayed on the label of vaccines and immunological products, additional necessary information can be included based on the specific requirements of each type of vaccine and immunological product, but it must not contradict the laws and this Circular, and must not obscure or mislead the required contents on the label. Non-required contents may include: code numbers, barcodes, symbols, marks used as trademarks... For imported vaccines and immunological products used in national programs or humanitarian aid, the outer packaging of the vaccine and immunological product must print the phrase: "Donated vaccine (immunological product), not for sale" or "National program vaccine (immunological product), not for sale" (printed by the importing unit after importation).

II. INSPECTION, AUDIT AND HANDLING OF VIOLATIONS:

1. Production and trading units of vaccines and immunological products must be subject to inspection by the Ministry of Health, Provincial Health Departments, and be subject to specialized audit by the Ministry of Health's Inspectorate and Provincial Health Departments' Inspectorates.

2. Violations of the law on labeling of vaccine and immunological products shall be handled according to the form prescribed by Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government promulgating the Regulations on Labeling of Goods Circulating Domestically and Exported and Imported Goods.

III. IMPLEMENTATION PROVISIONS

1. This Circular takes effect fifteen days after the date of issuance.

2. Vaccines and immunological products produced domestically or imported into Vietnam before the effective date of this Circular and still within their shelf life may continue to circulate with the approved label until the end of their shelf life.