Chương I Thông tư 01/2018/TT-BYT: Những quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Circular provides for information on labels, methods for labeling and package inserts of drugs and medicinal ingredients sold on the market; change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.

2. This Circular does not apply to labels of:

a) Drugs and medicinal ingredients which are used for export but not yet registered in Vietnam;

b) Drugs imported for non-commercial purposes as regulated in Clause 1 Article 75 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”);

c) Drugs imported to meet urgent need of national defense and security, epidemic control or disaster recovery as regulated in Clause 1 Article 67 of the Decree No. 54/2017/ND-CP.

Article 2. Interpretation of terms

For the purpose of this Circular, the terms below are construed as follows:

1. “commercial package of a drug” means the package that envelops the drugs and the package insert and is sold together with drugs. Commercial packages of drugs include primary package, secondary package, and probably intermediate package.

2. “intermediate package” means the package which is used to wrap one or some units of drugs that already have primary packages and contained in the secondary package.

3. “batch number” means a series of numbers or letters or both that helps recognize the batch of drug or medicinal ingredient and permits the trace of history of a batch of drugs or medicinal ingredients, including all production stages, quality inspections and sale of that batch of drugs or medicinal ingredients.

4. “original label” means the label that is first affixed by the manufacturer on the commercial packages of the drug or medicinal ingredient.

Article 3. Positions of labels of drugs or medicinal ingredients and package inserts

1. Positions of labels of drugs or medicinal ingredients shall follow regulations in Article 4 of the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017 on good labeling (hereinafter referred to as “Decree No. 43/2017/ND-CP”).

2. Package insert is an integral part of the drug label and contained in the secondary package. If a drug does not have the secondary package, the package insert must be printed or affixed on the primary package.

Article 4. Sizes of labels, sizes of letters and numbers on labels, colors of text, symbols, and pictures on the labels, languages on labels and package inserts

1. Sizes of labels, sizes of letters and numbers on labels, colors of text, symbols, and pictures on the labels of drugs or medicinal ingredients and package inserts shall follow regulations in Article 5 (excluding regulations in Point b Clause 2 Article 5) and Article 6 of the Decree No. 43/2017/ND-CP.

2. Compulsory information on a label of drug or medicinal ingredient and the package insert must be written in Vietnamese language, except for some contents which may be written in other Romance languages as regulated in Clause 4 Article 7 of the Decree No. 43/2017/ND-CP.

Article 5. Affixing secondary labels and addition or replacement of package inserts in Vietnam

1. If the original label of drugs or medicinal ingredients imported into Vietnam does not contain sufficient compulsory information as regulated by the Ministry of Health, the importer must keep the original label unchanged and affix the secondary labels in Vietnamese language in conformity with regulations of the Ministry of Health before such imported drugs or medicinal ingredients are sold on the market.

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

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

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

3. Principles and locations for affixing secondary labels and adding or replacing package inserts in Vietnam:

After the customs clearance is granted, importers of drugs or medicinal ingredients mentioned in Clause 1 and Clause 2 of this Article must affix the secondary labels, add or replace package inserts in Vietnamese language according to the following principles:

a) Secondary labels shall be affixed in a drug or medicinal ingredient storage facility that has GSP certificate of the importer;

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;

c) Affixing secondary labels or adding or replacing package inserts in Vietnamese language in Vietnam should avoid influencing the quality of drugs or medicinal ingredients.

4. In case of addition or replacement of package inserts in Vietnamese language as regulated in Point b Clause 3 of this Article, the secondary packaging facility must properly comply with GMP guidelines in course of adding or replacing package inserts as regulated in Point b Clause 3 of this Article and also submit reports to the Ministry of Health to serve the fulfillment of pharmacy business management and inspection tasks. To be specific:

a) Reports must be submitted within one (01) month from the completion of the addition or replacement of package inserts in Vietnam;

b) A report must contain the following compulsory contents: Name of importer; name of drug; registration number or import license number; batch number; manufacturing date; expiry date; quantity of drugs of which package inserts have been added or replaced.

5. The entity responsible for labeling shall supervise and cooperate with the facility in charge of affixing secondary labels or adding or replacing package inserts and assume responsibility for quality of drugs or medicinal ingredients during the affixing of secondary labels or addition or replacement of package inserts.

Article 6. Responsibility for labeling of drugs and medicinal ingredients and package inserts

1. 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.

2. With regard to drugs or medicinal ingredients manufactured in Vietnam:

a) The manufacturer and/or registrant are responsible for labeling and package inserts of drugs or medicinal ingredients manufactured and/or registered;

b) 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;

c) 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.

3. With regard to imported drugs or medicinal ingredients:

a) The importer and/or registrant of drugs are responsible for labeling and package inserts of drugs having registration numbers;

b) The importer and/or registrant of medicinal ingredients are responsible for labeling of imported medicinal ingredients;

c) The importer is responsible for labeling and package inserts of imported drugs without registration numbers.

4. 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 herein.