DECISION

PROMULGATION OF THE HANDBOOK FOR INTRODUCTION AND ADVERTISEMENT OF DRUGS

HEAD OF DRUG ADMINISTRATION OF VIETNAM

Pursuant to the Decree No. 188/2007/ND-CP dated December 27, 2007 on functions, missions, authority and organizational structure of the Ministry of Health;

Pursuant to the Decision No. 53/2008/QD-BYT dated December 30, 2008 on functions, missions, authority and organizational structure of the Drug Administration of Vietnam under the Ministry of Health;

Pursuant to the Circular No. 13/2009/TT-BYT dated September 01, 2009 by the Ministry of Health on guidelines for introduction and advertisement of drugs;

At the request of the Manager of  Medical and Cosmetic Introduction and Advertisement - Drug Administration of Vietnam,

DECIDES:

Article 1. This Decision is enclosed with the Handbook for introduction and advertisement of drugs

Article 2. This Decision comes into force from the date that it is signed.

Article 3. Chief of Office, Management of Medical and Cosmetic Introduction and Advertisement , Manager of Legal affairs and Integration - Drug Administration of Vietnam, Heads of organizations concerned shall be responsible for implementing this Decision./.

HANDBOOK

INTRODUCTION AND ADVERTISEMENT OF DRUGS
(Enclosed to the Decision No. 180/QD-QLD dated June 14, 2011)

I/ Objectives

The handbook for registration of medical introduction and advertisement adheres to regulations by the Government and Ministry of Health on drug advertisement. It provides specific guideline for organizations’ preparation of applications for introduction and advertisement of drugs and for administration of activities in introduction and advertisement of drugs in order to establish a general foundation for organizations’ introduction and advertisement of drugs in overt and transparent manners.

II/ Legislative documents

- Pharmacy Law No. 34/2005-QH11 dated June 14, 2005.

- Ordinance No. 39/2001/PL-UBTVQH10 dated November 16, 2011 by the Standing Committee of the National Assembly on advertisement.

- Government’s Decree No. 24/2003/ND-CP dated March 13, 2003 on details for the implementation of the Ordinance on Advertisement.

- Government’s Decree No. 45/2005/ND-CP dated April 06, 2005 on penalties against administrative violations in the medical sector.

- Government’s Decree No. 37/2006/ND-CP dated April 04, 2006 on details on trade introduction activities in the Commercial Law.

- Government’s Decree No. 68/2009/ND-CP dated August 06, 2009 on amendments to Section 7, Article 4 of the Government’s Decree No. 37/2006/ND-CP dated April 04, 2006.

- Circular No. 43/2003/TT-BVHTT dated July 16, 2003 by Ministry of Culture and Information on guidelines for the implementation of the Government’s Decree No. 24/2003/ND-CP dated March 13, 2003 on details for the implementation of the Ordinance on Advertisement.

- Joint Circular No. 01/2004/TTLT-BVHTT-BYT dated January 12, 2004 by the Ministry of Culture and Information and Ministry of Health on guidelines for medical advertisement.

- Pursuant to the Circular No. 13/2009/TT-BYT dated September 01, 2009 by the Minister of Health on guidelines for introduction and advertisement of drugs;

- Circular No. 08/2009/TT-BYT dated July 01, 2009 by the Minister of Health on promulgation of the list of non-prescription drugs.

- Decision No. 45/2007/QD-BYT dated December 18, 2007 by the Minister of Health on promulgation of the list of medicinal ingredients permissible for radio and television advertisement.

- Decision No. 59/2008/QD-BTC dated July 21, 2008 by the Minister of Finance on amendments to the Decision No. 44/2005/QD-BTC dated July 12, 2005 by the Minister of Finance on collection, payment, management and utilization of fees for trade assessments regarding conditional business lines in the medical sector, for assessments of criteria and eligibility for medical and pharmaceutical practices and for licensing of importation, exportation and practitioners.

- Decision No. 04/2008/QD-BYT dated February 01, 2008 by the Minister of Health on promulgation of the regulation on prescription of drugs for outpatients.

- Continuous training programs for drug introducers.

(Details of such documents are expressed in Appendix I).

Joint Circular No. 01/2004/TTLT-BVHTT dated January 12, 2004 by the Ministry of Culture and Information and Ministry of Health on guidelines for medical advertisement regulates these prominent details: 

a) Ministry of Culture and Information shall be responsible for leading and cooperating with the Ministry of Health to conduct state management of medical advertisement within authority.

b) Ministry of Health shall be responsible for guiding function-based Departments and Health Departments to handle applications and issue receipts of advertisement registration.

c) Ministry of Health shall authorize agencies to take in and process applications for advertisement as follows:

- Department of Treatment shall handle applications for advertisement of medical care provided by foreign invested facilities and health facilities employing foreigners to directly conduct examinations and treatments by modern drug.

- Department of Traditional Medicine shall handle applications for advertisement of traditional medical care provided traditional medicine facilities that receive foreign investments or employ foreigners to directly conduct medical examinations and treatments.

- Department of Health Equipment and Works shall handle applications, by medical equipment traders that are foreign invested or sell imports, for medical equipment advertisement.

- General Department of Preventive Medicine and HIV/AIDS Control shall handle applications for advertisement of insecticidal and microbicidal chemicals and products for household and medical uses;

- Drug Administration of Vietnam shall handle applications for drug advertisement and for introduction of drugs to health officers.

- Vietnam Food Administration shall handle applications for advertisement of foodstuffs and food additives that it announces and certify with regard to quality and food hygiene and safety, respectively.

- Departments of Health shall handle these applications for advertisement:

+ Advertisement of medical care (including traditional medicine, cosmetic surgery and physical rehabilitation) provided by health facilities located within authority areas except for those under the authority of the Department of Treatment and Department of Traditional Medicine - Ministry of Health as per Point a, Section 2, Part III of the relevant Joint Circular.

+ Advertisement of medical equipment by their producers and traders located within authority areas except for those under the authority of the Department of Health Equipment and Works - Ministry of Health as per Point a, Section 2, Part III of the relevant Joint Circular.

+ Advertisement of foodstuffs and food additives by food producers and traders located within authority areas except for those under the authority of Vietnam Food Administration - Ministry of Health as per Point a, Section 2, Part III of the relevant Joint Circular.

+ Advertisement by cosmetics producers and traders of cosmetic products that bring about direct effects on human health

+ Handle applications for organization of seminars to introduce drugs to health officers and for issuance of professional practice cards to drug introducers.

d) Inspectorate of Health and Inspectorate of Culture - Information shall be responsible for independently or jointly inspecting medical advertisements and take actions against violations within authority according to the laws.

Drug Administration of Vietnam and Ministry of Health’s Inspectorate shall inspect the legal compliance of entities concerning drug introduction and advertisement within authority in Vietnam.

Provincial departments of health shall be responsible for inspecting legal regulations within their authority areas.

III/ Guideline for registration and assessment of drug introduction and advertisement

A- Registration of drug introduction and advertisement

1. Drug introduction

1.1. Non-registered introduction of drugs

Traders of drugs shall be entitled and bound to introduce drugs, which they register, produce, import and distribute, to health officers and consumers.

The following information of drugs introduced to health officers is not subject to registration with the Drug Administration of Vietnam: Drug information on label and package insert included in drug registration applications approved by Drug Administration of Vietnam.

1.1. Registered introduction of drugs

Traders of drugs or mandated units shall be permitted to introduce drugs that have valid registration numbers for sale in Vietnam.

Drugs not having registration number for sale in Vietnam but licensed for sale in another country shall only be introduced to health officers in seminars. Organizers of seminars for introduction of drugs to health officers in a locality must apply in writing to the relevant Department of Health.

Local traders of drugs and foreign enterprises’ representative offices in possession of a license for Vietnam-based operations in drug and medicinal ingredients shall be entitled to hold seminars with health officers for introduction of drugs licensed for production and sale in a foreign nation.

Drug traders operating in a foreign country must work with a Vietnamese trader or health organization, such as a hospital, health institute, medical training facility, medical society or pharmacy society, to carry out a drug introduction seminar in Vietnam.

The following information of drugs must be registered with the Drug Administration of Vietnam:

- Drug information on registered label and package insert, which adopts changes to proportion, shape, size, color, image or arrangement;

- Drug information on registered label and package inserts, which is amended.

- Drug information not available on registered label and package insert;

- Drug information collected through market surveillance;

- Independent or new studies on drugs.

Written materials for introduction of drugs to health officers must adhere to Article 14 of the Circular.

2. Advertisement of drugs

- Organizations can apply in writing for introduction or advertisement of drugs that they have registered under their name. Such organizations can mandate other entities in writing to apply for introduction or advertisement. An entity mandated must bear legitimate juridical personality.

- Non-prescription drugs as defined by the Ministry of Health and granted registration numbers in effect can be advertised on books, newspapers, magazines, fliers, news websites, corporate websites, advertisers’ websites, panels, poster, banner, luminescent, aerial or underwater items, means of transport, moving objects and other means of advertisement.

- Drugs to which Ministry of Health has granted registration numbers in effect for sale in Vietnam or contain active ingredients permitted by Ministry of Health for radio and television advertisement can be registered for advertisement on radio and television.

- Organizations promoting or advertising drugs shall be held liable for the content and legality of information disclosed through their introduction or advertisement of drugs.

- Drug advertisements must adhere to Article 21 of the relevant Circular.

3. Application for introduction and advertisement

3.1. Definition

Organizations must submit a sufficient application for each content (sample) of an advertisement on newspaper, magazine, flier, poster, items, etc. or a script for radio or television advertisement according to Clause 3.2.1.

Organizations must submit a sufficient application for each drug introduction in a seminar (that introduces one or various drugs in similar or varied contents or forms) according to Clause 3.2.2.

3.2. Composition of an application

3.2.1 An application for drug advertisement includes:

a) The filled-out form no 3a-TT for registration of drug advertisement;

b) Planned layout and content of the drug advertisement; video or audio materials with scripts of television or radio advertisements. Such script must give thorough description of images, spoken lines and sounds;

c) Written materials for reference and assessment of advertisements;

d) The copy of the package insert approved by Drug Administration of Vietnam;

dd) The copy of the product sale license or the copy of the decision on issuance of registration number, as issued by the Drug Administration of Vietnam (only the page indicating such decision and the appendix defining the drug to be advertised are required);

e) The copy of the applicant’s certificate of eligibility for pharmacy business or the foreign enterprise’s license for Vietnam-based operations in drug and medicinal ingredients;

g) The copy of the assessment fee receipt.

If the applicant is not the organization having registered the drug under its name, the papers in Point e shall be replaced with:

+ The letter of mandate made by the organization having registered the drug under its name to the organization applying for drug advertisement (as per Appendix II)

+ The mandated organization’s certificate of business registration.

Every document in the application must be fan stamped by the organization preparing the application. Only photocopies of documents as stated in Point d, dd and e of this Article are required; however, they must bear the official seal of the applicant for advertisement.

The planned advertisement material or script must be submitted in two copies. Upon finalization, 01 copy shall be retained by the managing authority and 01 copy shall be stamped by Drug Administration of Vietnam before delivered to the applicant for advertisement.

3.2.2. An application for drug introduction seminar includes:

- The planned agenda of the seminar (time, location);

- The content of each report, name and scientific title of the reporter;

- The filled-out form no 2a-QC for registration of seminar for introduction of drug to health officers;

- Written materials to be displayed or handed out in the seminar;

- Written materials concerning the drug to introduced in the seminar;

- Reference documents (if any).

Details of drug introduction in the seminar must suffice according to Section 2, Article 16 of the Circular No. 13/2009//TT-BYT dated September 01, 2009.

Juridical persons shall lodge applications according to Section 1, Article 3 of the Circular No. 13/2009/TT-BYT dated September 01, 2009.

Every document in the application must be fan stamped by the organization preparing the application.

4. The fee for assessment of an application for drug introduction or advertisement

- An applicant for introduction or advertisement of drugs as per Circular No. 13/2009/TT-BYT dated September 01, 2009 must pay the fee for application assessment to the authority that takes in applications according to the Decision No. 59/2008/QD-BTC dated July 21, 2008 by Ministry of Finance.

- Each content of drug introduction or advertisement shall incur an assessment fee on an application for introduction or advertisement of drug as follows:

a) These contents shall be deemed as an application:

- A content for introduction or advertisement of a drug that is produced in one content ratio or one dosage form;

- A content for introduction or advertisement of one product that appears in two or more forms of drugs containing similar ingredients but made in different content ratio, dosage form or administration route by one manufacturer;

- A content for introduction or advertisement of a drug to a target audience through various means (e.g. flier, poster, book, newspaper, etc.);

b) These contents shall not be deemed as an application:

- A variety of different contents are used to introduce or advertise one drug to a target audience. In this case, each of such contents shall be considered as one application.

- A content is used to introduce or advertise a variety of different drugs to one target audience. In this case, the information of each of the drugs shall be considered as one application.

5. Procedure for submission of applications for introduction or advertisement of drugs

(According to Appendix III)

6. Handling of reports

- Report handling agency: the office of Drug Administration of Vietnam (for reports sent by hand or by post) at 138A Giang Vo, Ba Dinh, Hanoi. Telephone: 0438464413.

- Relevant matters:

+ Complaints about applications for drug introduction and advertisement, which shall be reviewed and answered according to the Ministry of Health’s general procedure for handling of documents received and sent.

+ Inquiries regarding implementation of legal regulations on drug introduction and advertisement, which are answered and updated in Part IV of this Handbook and published on the website of the Drug Administration of Vietnam.

+ Reports on activities of drug introduction or advertisement in violation of regulations, which shall be taken in and settled according to the procedure for settlement of violations regarding drug introduction and advertisement in Part V of this Handbook.

B- Assessment of drug introduction or advertisement

1. Grounds for assessment of contents for drug introduction and advertisement

- Package insert approved by Drug Administration of Vietnam.

- Disquisitions on drug from the National pharmacopoeia or Martindale.

- Documents that substantiate citations shown in the contents for drug introduction or advertisement to be registered.

Though a package insert or label has been approved, its content shall not be included in an introduction or advertisement of drug if not conforming to this Handbook and legal regulations on drug introduction and advertisement.

2. Assessment:

- An assessment team of specialists (formed by decisions of the Head of the Drug Administration) shall assess the application

- The team bears the duty to assess the application for drug introduction and advertisement according to current regulations on drug introduction and advertisement and relevant documents.

- The team leader shall give direct instructions and assume liabilities for the team’s activities.

- The team leader shall only conclude the assessment of an application in the presence of at least two thirds of the members of the team. The team leader may organize a meeting with team members, if necessary, to reach unanimity.

- Team members involved in the assessment shall sign the record of assessment of the application and be held liable for all recommendations in such record.

3. Guideline for assessment of contents for drug introduction and advertisement

3.1. Presentation of citations and substantiating documents

3.1.1. Substantiating documents

- Substantiating documents with adequate information of clinical research (Part IV) must present sufficient information about: research aims, methodology, sampling size, steps, result, discussion, conclusion, etc.

- Substantiating documents must be updated and enclosed with the names of such documents, authors and publishing time.

- Information from an active ingredient research must be cited verbatim in the introduction or advertisement content that mentions such active ingredient.

+ The name of a proprietary drug can be cited from a proprietary drug research.

+ The enterprise sponsoring the research shall not cite the name of a proprietary drug if that research does not mention the name of such proprietary drug.

- Information from animal and in vitro studies cannot be cited in contents for drug introduction or advertisement.

- Substantiating documents in other foreign languages than English must be accompanied with a Vietnamese translation bearing the applicant’s seal.

- The applicant must be responsible for the legality and accuracy of substantiating documents.

3.1.2. Presentation

- Contents for drug introduction and advertisement must list (and number) reference documents according to regulations. Names of reference documents and methodology cannot be displayed in noticeable grand headlines.

- Ordinal numbers of reference documents must be specified after citations shown in contents for introduction or advertisement. Research findings must be specified in detail as general findings are insufficient.

3.2. Images prohibited from contents for drug introduction and advertisement:

- Obscene images against Vietnamese conventions;

- Images of animals and plants under national protection or images not related to drug, such as tiger, panther, bear, horse, barbed wire, cactus, flame, exaggerated expressions of pain or diseases, etc., which lead consumers’ misunderstandings.

- Images or symbols of health officers shall not be used for advertisement or recommendation of drugs.

- Images that exaggerate medical effects or do not suit or connect with the composition or effects of the drug.

3.2. These words and phrases are prohibited from contents for drug introduction and advertisement:

- Thuốc này là số 1, là tốt hơn tất cả (This drug is number 1 or the best);

- Sử dụng thuốc này là biện pháp tốt nhất (This drug is the best solution);

- Sử dụng thuốc này không cần có ý kiến của thầy thuốc (This drug can be used without professional counsels)

- Thuốc này hoàn toàn vô hại, không có tác dụng phụ, không có chống chỉ định, không có tác hại (This drug is completely harmless, does not have side effect, does not have contraindications, does not cause harms);

- Điều trị tận gốc, tiệt trừ (Absolute treatment)

- Hàng đầu, đầu bảng, đầu tay (top, board leading)

- Lựa chọn số 1 (Number one choice)

- Chất lượng tốt / đảm bảo 100% (Good quality / 100% guaranteed)

- An toàn (safe)

- Dứt, cắt đứt, chặn đứng, giảm ngay, giảm liền, giảm tức thì (End, cut, stop, reduce disease promptly, immediately or at once)

- Yên tâm (assured)

…

3.4 Test results and certificates from competent authorities, medals awarded to products and/or entities in exhibitions and clinical research findings lacking scientific or medical grounds cannot be used for introduction and advertisement of drugs.

Name, symbol, image, position, reputation and correspondence of medical or pharmaceutical organizations and health officers, patients’ letters of gratitude cannot be used to introduce or recommend drugs. For example:

+ Symbol and name of organizations and societies such as FDA, medical associations, heart associations, research institutes, etc.

+ Mails, research findings, meals.

+ ISO, GMP, GSP, GLP, etc.

+ Registration numbers given by Drug Administration of Vietnam and drug management authorities in other countries.

+ National names such as “German or European ingredient”.

3.5. Effect of each medicinal constituent

Effects of each constituent of a drug (though displayed on the package insert) must not be abused to over-advertise medicinal effects and cause confusion between each constituent’s effects and the drug’s effects.

3.6. Name and address of the producer

The producer’s name and address must be specified in full.

Television commercials: Foreign drug must be enclosed with the producer’s name and country of production while domestic drug must be enclosed with the producer’s trading name and logo.  

Inference of medicinal effects

Medicinal effects cannot be inferred, for example:

+ Kéo dài tuổi thanh xuân (Prolong youth)

+ Làn da mãi mãi tươi trẻ (Skin invigorated always)

+ Kéo dài tuổi thọ (Prolong age)

+ Bảo vệ cuộc sống (Protect life)

+ Được vóc dáng, được cả làn da (Keep shape and nourish skin at the same time)

...

3.8. Citations from substantiating documents cannot be inserted into radio advertisements or television commercials.

3.9. Indications

Only indications on approved package inserts are permissible.

If the package insert is not pertinent to the nature of the drug, it shall be revised according to the national pharmacopeia and Martindale.

3.10. Comparison that state an organization’s drug better than another’s is prohibited.

- Documents from studies that compare active ingredients without specifying names of any drug can be cited as graphs but not as conclusions for introduction or advertisement of drug (except for conclusions endorsed in the national pharmacopeia).

- If documents substantiating bioequivalence tests are available (the name of the tested drug must match the name of the drug registered for sale in Vietnam and/or the comparator in the innovator drug list made by WHO, FDA, EMEA), results of bioequivalence tests can be cited for introduction or advertisement of drugs. However, it must be stated that the drug is analyzed against a comparator, whose commercial name must not be revealed. If the name of the tested drug does not match the name of the drug registered for sale in Vietnam, the tested drug must be affirmed by managing authorities to be the drug registered in Vietnam.

3.11. Display of advertisement

Images and font size must be clear (VnTime3 11, color of images, words and numbers must be in contrast with the background color) Details of the product must be displayed in such a manner that helps readers distinguish different sections.

IV/ Inquiries about implementation of Circular No. 13/2009/TT-BYT dated September 01, 2009 by Ministry of Health on guidelines for introduction and advertisement of drugs.

(According to Appendix IV)

V/ Violations and penalties

1. Legal grounds

- Government’s Decree No. 45/2005/ND-CP dated April 06, 2005 on penalties against administrative violations in the medical sector.

- Government’s Decree No. 37/2006/ND-CP dated April 04, 2006 on details on trade promotion activities in the Commercial Law.

- Government’s Decree No. 68/2009/ND-CP dated August 06, 2009 on amendments to Section 7, Article 4 of the Government’s Decree No. 37/2006/ND-CP dated April 04, 2006.

- Circular No. 13/2009/TT-BYT dated September 01, 2009 by the Ministry of Health on guidelines for introduction and advertisement of drugs;

2. Principles for actions (Circular No. 13/2009/TT-BYT dated September 01, 2009 by the Ministry of Health on guidelines for introduction and advertisement of drugs)

- All organizations involved in violations (producer, distributor, applicant for drug registration or drug introduction and advertisement, etc.) shall be penalized as per regulations.

- For those committing initial violations, the Drug Administration of Vietnam shall consider their explanations and documents enclosed to weigh their violations and issue written warnings.

- For those repeating violations, the Drug Administration of Vietnam shall inform them in writing of prohibition from introduction and advertisement of drugs (for which violations were committed) according to their applications and from application for introduction and advertisement of drug in 3 to 12 months as per regulations. As follows:

+ An organization violating Section 14, Article 5 of the Circular cannot apply for introduction and advertisement of drug in 3 months. 

+ An organization violating Section 14, Article 5 of the Circular twice in a year cannot apply for introduction and advertisement of drug in 6 months.

+ An organization violating the Circular thrice in a year cannot apply for introduction and advertisement of drug in 12 months.

- Drug Administration of Vietnam shall publish their violations on its website and inform the relevant Inspectorate and competent authorities for actions as per the laws.

- Organizations and individuals committing violations shall be subjected to administrative penalties, advertisement suspension and revocation of registrations for the drugs involved, suspension or revocation of foreign enterprise’s license for Vietnam-based medical operations. Moreover, they may face criminal prosecution as per the laws.

3. Procedure for remedial actions

(According to Appendix V)