Chương VII Nghị định 54/2017/NĐ-CP : Hồ sơ, trình tự thủ tục và thẩm quyền xác nhận nội dung thông tin, quảng cáo thuốc

Chapter VII

CERTIFICATION OF DRUG INFORMATION AND DRUG ADVERTISEMENTS

Section 1. CERTIFICATION OF DRUG INFORMATION

Article 105. Methods of provision of drug information

Information shall be provided for medical practitioners by using the following methods:

1. Provision of drug information via sale representatives.

2. Publishing of documents containing drug information.

3. Holding pharmaceutical conferences.

Article 106. Applicants for certification of drug information

1. The following entities may apply for certification of drug information:

a) Establishments applying for drug registration in Vietnam;

b) Representative offices in Vietnam authorized by the overseas establishments that apply for drug registration in Vietnam;

c) Vietnamese pharmacy business establishments authorized by the establishments mentioned in Clause 1a of this Article;

d) Vietnamese drug importers, which may only provide information about the drugs they import using the method specified in Clause 3 Article 105 of this Decree.

2. Applicants for drug registration, including those authorizing the entities mentioned in Clause 1b or 1c of this Article to apply for certification of drug information, and Vietnamese drug importers applying for certification of drug information shall take responsibility for the information provided.

Article 107. Issuance and reissuance of the certification of drug information and adjustment of certified drug information

1. The certification of drug information shall be issued in the following cases:

a) The certification of drug information is applied for the first time;

b) The certification of drug information was issued but the applicant for drug registration, drug name, ingredients, concentration, dosage form, indications, contraindications, dosage, uses for special cases, warnings or drug safety information is changed.

2. The certification of drug information shall be reissued in the following cases:

a) The certification of drug information is lost or damaged;

b) The issuer makes an error on the certification of drug information.

3. Certified drug information may be adjusted in case of changes other than those specified in Clause 1b of this Article.

Article 108. Application for the certification of drug information

1. An application for the certification of drug information which is provided using the method mentioned in Clause 2 Article 105 of this Decree consists of:

a) Form No. 01 in Appendix VI enclosed herewith;

b) A design of the document containing drug information;

c) Specimens of the label and package insert approved by the Ministry of Health;

d) Reference documents about the drug information to be certified (if any);

dd) The marketing authorization;

e) The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; the certificate of eligibility for drug business if the applicant is a Vietnamese pharmacy business establishment;

g) In case the applicant for certification of drug information is authorized by the applicant for drug registration, the authorization document.

2. An application for the certification of drug information which is provided using the method mentioned in Clause 3 Article 105 of this Decree consists of:

a) Form No. 02 in Appendix VI enclosed herewith;

b) Drug information;

c) Specimens of the label and package insert approved by the Ministry of Health;

d) Reference documents about the drug information to be certified (if any);

dd) the marketing authorization or the license for drug import;

e) The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; the certificate of eligibility for drug business if the applicant is a Vietnamese pharmacy business establishment;

g) In case the applicant for certification of drug information is authorized by the applicant for drug registration, the authorization document;

h) The agenda of the pharmaceutical conference.

Article 109. Composition of the application for reissuance of the certification of drug information

1. Form No. 03 in Appendix VI enclosed herewith.

2. A design of the drug information sheet or the drug information.

3. A confirmation that the error is made by the issuer in the case mentioned in Clause 2b Article 107 of this Decree.

Article 110. Composition of an application for adjustment to certified drug information

1. Form No. 04 in Appendix VI enclosed herewith which specifies the adjustment and reasons for adjustment.

2. Documents proving the adjustment.

Article 111. Documents in the applications for issuance and reissuance of the certification of drug information and application for adjustment of certified drug information

1. Documents mentioned in Clause 1c, Clause 1dd, Clause 2c and Clause 2dd of Article 108 shall be copies.

2. Documents mentioned in Clause 1d, Clause 1e, Clause 2d, Clause 2e of Article 108 and Clause 2 of Article 110 of this Decree shall be copies bearing the seal of the applicant if they are issued by the Ministry of Health or certified true copies if they are not issued by the Ministry of Health.

3. Documents mentioned in Clause 1g and Clause 2g of Article 108 of this Decree shall be original copies or certified true copies.

4. Documents mentioned in Clause 3 of Article 109 of this Decree shall be original copies.

5. Documents mentioned in Clause 1b and Clause 2b of Article 108 and Clause 2 of Article 109 of this Decree are 02 original copies.

6. Each application for issuance or reissuance of the certification of drug information shall contain:

a) 01 specimen of the design mentioned in Clause 1 Article 108 of this Decree or 01 sheet of drug information mentioned in Clause 2 Article 108 of this Decree for a drug;

b) 01 specimen of the design mentioned in Clause 1 Article 108 of this Decree or 01 sheet of drug information mentioned in Clause 2 Article 108 of this Decree for more than one drug that have the same active ingredients and route of administration, the same manufacturer but different concentrations or dosage forms.

7. Documents shall be printed on A4 paper sheets and bear fan stamping of the applicant for the certification of drug information.

Article 112. Presentation of drug information

1. Drug information shall satisfy the following requirements:

a) Information is sufficient according to Clause 5a Article 76 of the Law on Pharmacy; information and images not related to the drug or use of the drug and similar information and images specified in Article 126 of this Decree are not permitted;

b) Reference documents and extracts therefrom are specified. The extracts must be accurate without addition or removal of information which leads to misunderstanding of the safety and efficacy of the drug;

c) The drug information is written in Vietnamese language, except for untranslatable information;

d) Minimum font size: 12; Font: VnTime or Times New Roman; Page: A4.

2. The text “Tài liệu thông tin thuốc” (“Drug information”) must be displayed on the top of all pages. Pages of a multi-page document must be numbered. The first page must contain the table of content and the text “Số Giấy xác nhận nội dung thông tin thuốc của Bộ Y tế…/XNTT/…, ngày ... tháng ... năm ...” (“Number and date of the certification of drug information issued by the Ministry of Health: …”)

3. In case of a pharmaceutical conference, the drug information must include the names and academic ranks of the speakers, whose medical or pharmaceutical qualifications are suitable for the drug introduced.

Article 113. Procedures for issuance of the certification of drug information

1. The applicant shall submit the application for the certification of drug information to the competent authority specified in Article 116 of this Decree.

2. Within 15 days from the day on which the satisfactory application is received, the receiving authority shall give the applicant Form No. 05 or Form No. 06 in Appendix VI enclosed herewith. If the application is rejected, the receiving authority shall respond and provide explanation in writing.

3. If the application is not satisfactory, the receiving authority shall request the applicant in writing to complete the application. To be specific:

a) The written request shall specify necessary adjustments and/or additions;

b) Within 15 days from the day on which the supplemented application is received, the receiving authority shall give the applicant Form No. 05 or Form No. 06 in Appendix VI enclosed herewith or reject the application and provide explanation.

c) Within 90 months from the day on which additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. Otherwise, the application will be rejected.

4. While the application is being processed, the receiving authority shall suspend granting the confirmation and issue a notification of the suspension if the information about drug safety and efficacy in the package insert is found unsatisfactory or not updated as requested by competent authority or according to instructions given or recognized by the Ministry of Health. The suspension will be lifted when the applicant submits adjusted or updated information that ensures safety of drug users.

5. At least working 03 days before providing drug information using the method mentioned in Clause 3 Article 105 of this Decree, the holder of the certification of drug information shall send a notification of the time and location and a copy of the certification of drug information to the Department of Health of the province where drug information is provided.

If the time or location is changed, the Department of Health shall be informed at least 01 working day before drug information is provided.

6. The application will be rejected if the applicant, including authorized applicants mentioned in Clause 1b and Clause 1c Article 106 of this Decree, commits any of the following violations:

a) Legal documents issued by regulatory authorities in the application for certification of drug information are falsified or forged;

b) The drug information is provided or the drug advertisement is run before its contents are certified by a competent authority or against the contents certified by a competent authority;

c) A certificate not recognized by the Ministry of Health, another organization’s or individual’s name, symbol, images, letters or reputation is included in the drug information or advertisement.

d) A clinical trial result, pre-clinical trial result, test result or bioequivalence study result not recognized by the Ministry of Health is included in the drug information or advertisement;

dd) Drug information is provided or drug advertisement is run despite the change in its contents that requires another certification of drug information or drug advertisement specified in Clause 1b Article 107 or Clause 1b Article 120 of this Decree.

7. From the day on which the violation is notified by a competent authority, the applicant shall be suspended from submitting the application for the certification of drug information or drug advertisement for:

a) 01 – 02 years in the cases specified in Clause 6a of this Article;

b) 06 – 12 months in the cases specified in Clause 6b, Clause 6c or Clause 6d of this Article;

c) 03 – 06 months in the cases specified in Clause 6dd of this Article.

Article 114. Procedures for reissuance of the certification of drug information

1. The applicant for reissuance of the certification of drug information shall submit an application to the competent authority in accordance with Article 116 of this Decree.

2. Within 10 working days from the day on which the satisfactory application is received, the receiving authority shall give the applicant Form No. 05 or Form No. 06 in Appendix VI enclosed herewith.

Article 115. Procedures for adjusting certified drug information

1. The applicant for adjustment to certified drug information shall submit an application to the competent authority in accordance with Article 116 of this Decree.

2. Within 07 working days from the day on which the application is received, the applicant may make the adjustment if no response is given by the receiving authority. If the adjustment is rejected, the receiving authority shall respond and provide explanation in writing.

Article 116. Power to issue, reissue the certification of drug information and adjust certified drug information

1. The Ministry of Health has the power to issue, reissue the certification of drug information and adjust information it confirms in the cases specified in Clause 2 Article 105 of this Decree.

2. Departments of Health of provinces have the power to issue, reissue the certification of drug information and adjust information they confirm in the cases specified in Clause 3 Article 105 of this Decree.

Article 117. Effect of the certification of drug information

1. The certification of drug information is effective nationwide.

2. The certification of drug information does not have a specific expiration date and shall be invalidated in the following cases:

a) The marketing authorization or the license for drug import is revoked;

b) A change to drug information is made that requires issuance of another certification of drug information according to Clause 1b Article 107 of this Decree.

Section 2. CONFIRMATION OF DRUG ADVERTISEMENT CONTENTS

Article 118. Means of advertising drugs

Drugs may be advertised through the means of advertising defined by advertising laws.

Article 119. Applicants for confirmation of drug advertisement contents

1. The following entities may apply for confirmation of drug advertisement contents:

a) Establishments applying for drug registration in Vietnam;

b) Representative offices in Vietnam authorized by the overseas establishments that apply for drug registration in Vietnam;

c) Vietnamese pharmacy business establishments authorized by the establishments mentioned in Clause 1a of this Article.

2. Applicants for drug registration, including those authorizing the entities mentioned in Clause 1b or 1c of this Article to apply for confirmation of drug advertisement contents, shall take responsibility for the drug advertisement contents.

Article 120. Issuance and reissuance of the certification of drug advertisement contents and adjustment thereto

1. The certification of drug advertisement contents shall be issued in the following cases:

a) The certification of drug advertisement contents is applied for the first time;

b) The certification of drug advertisement contents was issued but the applicant for drug registration, drug name, ingredients, concentration, dosage form, indications, contraindications, dosage, uses for special cases, warnings or drug safety information is changed.

2. The certification of drug advertisement contents shall be reissued in the following cases:

a) The certification of drug advertisement contents is lost or damaged;

b) The issuer makes an error on the confirmation of drug advertisement contents.

3. Certified drug advertisement contents may be adjusted in case of changes other than those specified in Clause 1b of this Article.

Article 121. Application for the certification of drug advertisement contents

1. An application for the certification of drug advertisement contents, except for advertisements in the form of conferences, conventions or events, consists of:

a) Form No. 01 in Appendix VI enclosed herewith;

b) The graphic design of the drug advertisement; the audio or video track of the advertisement on audio or video news and other means of audio and video advertisements defined by advertising laws;

c) Specimens of the label and package insert approved by the Ministry of Health;

d) Reference documents about the drug advertisement contents to be certified (if any);

dd) The marketing authorization;

e) The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; the certificate of eligibility for drug business if the applicant is a Vietnamese pharmacy business establishment;

g) In case the applicant for the confirmation of drug advertisement contents is authorized by the applicant for drug registration, the authorization document.

2. An application for the certification of contents of drug advertisement in the form of a conference, convention or event consists of:

a) Form No. 02 in Appendix VI enclosed herewith;

b) The drug advertisement contents;

c) Specimens of the label and package insert approved by the Ministry of Health;

d) Reference documents about the drug advertisement contents to be certified (if any);

dd) The marketing authorization;

e) The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; the certificate of eligibility for drug business if the applicant is a Vietnamese pharmacy business establishment;

g) In case the applicant for the confirmation of drug advertisement contents is authorized by the applicant for drug registration, the authorization document;

h) The expected agenda of the conference, convention or event.

Article 122. Application for reissuance of the certification of drug advertisement contents

1. Form No. 03 in Appendix VI enclosed herewith.

2. The graphic design, audio or video track of the advertisement or contents of the advertisement to be certified.

3. An confirmation that the error is made by the issuer in the case mentioned in Clause 2b Article 120 of this Decree.

Article 123. Composition of an application for adjustment to certified drug advertisement contents

1. Form No. 04 in Appendix VI enclosed herewith which specifies the adjustment and reasons for adjustment.

2. Documents proving the adjustment.

Article 124. Documents in the application for certification of drug advertisement contents and adjustment thereto

1. Documents mentioned in Clause 1c, Clause 1dd, Clause 2c and Clause 2dd of Article 121 shall be copies.

2. Documents mentioned in Clause 1d, Clause 1e, Clause 2d, Clause 2e of Article 121 and Clause 2 of Article 123 of this Decree shall be copies bearing the seal of the applicant if they are issued by the Ministry of Health or certified true copies if they are not issued by the Ministry of Health.

3. Documents mentioned in Clause 1g and Clause 2g of Article 121 of this Decree shall be original copies or certified true copies.

4. Documents mentioned in Clause 3 of Article 122 of this Decree shall be original copies.

5. Documents mentioned in Clause 1b and Clause 2b of Article 121 and Clause 2 of Article 122 of this Decree are 02 original copies.

6. Each application for issuance or reissuance of the confirmation of drug advertisement contents shall contain:

a) 01 specimen of the graphic design or audio track or video track of the advertisement mentioned in Clause 1 Article 121 of this Decree or 01 specimen of the drug advertisement mentioned in Clause 2 Article 121 of this Decree for a drug;

b) 01 specimen of the graphic design or audio track or video track of the advertisement mentioned in Clause 1 Article 121 of this Decree or 01 specimen of the drug advertisement mentioned in Clause 2 Article 121 of this Decree for more than one drug that have the same active ingredients and route of administration, the same manufacturer but different concentrations or dosage forms.

7. The documents shall be printed on A4 papers. In case of advertisements on billboards, the drug advertisement contents may be printed on an A3 paper with specific ratio. All documents in the application must bear the applicant’s seal. If the advertisement object is three-dimensional, a description on A3 paper with the following information shall be included:

a) The object;

b) Numbers and dimensions of the sides;

c) The ratio of the specimen to the real object.

Article 125. Requirements applied to drug advertisement contents

1. The drug advertisement contents shall comply with the following documents:

a) The label and package insert approved by the Ministry of Health;

b) The treatise on the drug in the National Pharmacopoeia of Vietnam;

c) Related instructions provided or recognized by the Ministry of Health.

2. The drug advertisement contents have the following compulsory information:

a) Drug name;

b) Active ingredients or herbal materials in the approved package insert. Names of herbal materials must be written in Vietnamese language. Names of untranslatable foreign herbal materials may be written in Latin language;

c) Indications;

d) Uses;

dd) Dosage;

e) Contraindications and warnings for special users (pregnant women, breast-feeding women, children, old people, people having chronic diseases);

g) Cautions and what to avoid when using the drug;

h) Side effects and adverse effects;

i) Name and address of the manufacturer;

k) The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);

l) The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;” (“Number and date of the certification of drug advertisement contents issued by the Ministry of Health: …”) at the end of the first page;

m) Pages of a multi-page document must be numbered. The first page must specify the number of pages and contain the table of content;

n) Reference documents and extracts therefrom are specified. The extracts must be accurate without addition or removal of information which leads to misunderstanding of the safety and efficacy of the drug.

3. The contents of an audio or video advertisement must contains sufficient information specified in Points a, b, c, e, i, k Clause 2 of this Article. Information mentioned in Points a, b, c, e, k Clause 2 of this Article must be read aloud. If the drug consists of 03 or more active ingredients, each of them or the groups of vitamins, minerals and herbal materials must be read aloud.

4. Contents of advertisements on online newspapers, websites, electronic devices, advertising screens and other means of advertising defined by advertising laws:

a) The contents of an advertisement that has sounds shall comply with regulations of Clause 3 of this Article;

b) The contents of an advertisement without sounds shall comply with regulations of Clause 2 of this Article.

If the advertisement is an audio or video track that has multiple pages or footages, the pages or footages must be continuous and stay still for viewers to read all information; the page or footage that contains product information must be still for viewers to read such information. The script must specify how the pages of a multi-page advertisement are shown.

Such an advertisement must not advertise more than one drugs to avoid confusion.

5. The contents of an outdoor advertisement shall be shown on one side of the board and contains the information specified in Points .a, b, i, k, l Clause 2 of this Article. If the advertisement contains information about the effects and indications of the drug, sufficient information specified in Clause 2 of this Article must be provided.

6. Voice and text in a drug advertisement shall comply with the Law on Advertising.

7. Minimum font size: 12; Font: VnTime or Times New Roman; Page: A4.

8. The script must clearly describe the graphics, dialogues, text and music.

9. A drug advertisement may only provide information about the drug and may not provide information not related to the drug.

Article 126. Information and images banned from drug advertisements

1. Information and images prescribed in the Law on Advertising.

2. Information that causes misunderstanding about the ingredients, effects, indications or origin of the drug.

3. Information causing the viewers to believe that the drug is the best, the drug can be used without physician’s counsel, the drug is completely harmful, the drug has no contraindications or adverse effects.

4. Words or images that exaggerate the effects of the drug.

5. Information that equates effects of some ingredient of the drug with effects of the drug.

6. The following words and phrases: “điều trị tận gốc”, “tiệt trừ”, “chuyên trị” (“complete treatment"), “hàng đầu”, “đầu bảng”, “đầu tay” (“best”, “top”), “lựa chọn”, “chất lượng cao” (“high-quality”), “đảm bảo 100%” (“100% guarantee”), “an toàn” (“safe”), “dứt”, “cắt đứt”, “chặn đứng” (“stop”, “end”), “giảm ngay”, “giảm liền”, “giảm tức thì” (“relieve instantly”), “khỏi ngay”, “khỏi hẳn” (“treat instantly”), “yên tâm”, “không lo”, “khỏi lo” (”no worries”), “khuyên dùng” (“recommended”), “hotline”, “điện thoại tư vấn” (“hotline”).

7. The following indications:

a) Treatment of tuberculosis or leprosy;

b) Treatment of sexually transmitted diseases;

c) Treatment of insomnia;

d) Aphrodisiac indications;

dd) Treatment of cancers or tumors;

e) Drug detoxification;

g) Treatment of diabetes mellitus or similar metabolic disorders;

h) Treatment of viral hepatitis or new dangerous diseases.

8. Drug or medicinal material quality test results.

9. Pre-clinical study results.

10. Clinical study results or bioequivalence study results that have not been recognized by the Ministry of Health.

11. Names, positions, letters of other organizations or individuals used for advertising purposes.

12. Origin of the drug or medicinal material used for advertising purposes.

13. Image, name or symbol of a health worker.

14. Images of an animal or plant on the list of priority protected endangered, precious and rare species.

15. Words that are expressed as advice or tips that recommend the drug.

16. Images of patients used for description of symptoms or effects of the drug that are not conformable with relevant documents and instructions provided or recognized by the Ministry of Health.

Article 127. Procedures for issuance and reissuance of the certification of drug advertisement contents and adjustment to certified drug advertisement contents

1. The applicant for the certification of drug advertisement contents or adjustment to certified drug advertisement contents shall submit an application to the Ministry of Health.

2. Procedures for issuance and reissuance of the certification of drug advertisement contents or adjustment to certified drug advertisement contents are the same as the procedures specified in Article 113, Article 114 and Article 115 of this Decree.

Article 128. Power to issue, reissue the certification of drug advertisement contents and adjust certified drug advertisement contents

The Ministry of Health has the power to issue, reissue the certification of drug advertisement contents and adjust certified drug advertisement contents.

Article 129. Effect of certification of drug advertisement contents

1. The certification of drug advertisement contents does not have a specific expiration date and shall be invalidated in the following cases:

a) The marketing authorization expires;

b) The marketing authorization is revoked;

c) A change to drug information is made that requires issuance of another certification of drug advertisement contents according to Clause 1b Article 120 of this Decree;

d) A regulatory body recommends that the use of the drug should be restricted or supervised by medical practitioners;

dd) The drug contains an active ingredient or herbal material that has been removed from the list of OTC drugs promulgated by the Minister of Health.

2. When the marketing authorization is renewed, the certification of drug advertisement contents will be automatically renewed with the same duration as that of the marketing authorization.