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The Decision 2557/2002/qd-Byt: On "regulation Of Information, Advertising For Medications And Cosmetics Directly To Human Health"

Original Language Title: Quyết định 2557/2002/QĐ-BYT: Về việc ban hành “Quy chế thông tin, quảng cáo thuốc dùng cho người và mỹ phẩm ảnh hưởng trực tiếp đến sức khỏe con người”

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The decision on issuing "information regulation, advertising for medicines and cosmetics directly to human health" _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MINISTER of health pursuant to Decree No. 68/CP dated 11/10/1993 of the Government Regulation, functions, tasks, powers and organization of the Ministry of health;
The base ad Ordinance No. 39/2001/PL-UBTVQH10 on 16/11/2001;
Pursuant to Decree No. 59/2002/ND-CP dated 4/6/2002 of the Government on the abolition of certain licenses and replace a number of licenses equal to other management methods;
Pursuant to decision No. 547-QD/TTg issued on 23/8/1996 of the Prime Minister on the establishment of the Vietnam pharmaceutical Management Bureau affiliated to the Ministry of health;
At the suggestion of Mr. Vietnam Drug Administration Bureau Chief;
Article 1 DECISION. Attached to this decision "information regulation, advertising for medicines and cosmetics directly to human health" in article 2. This decision has effect from the date of 4/7/2002 and replaces decision No 322/BYT-QĐ dated 28/2/1997 of the Ministry of Health issued the "regulation of information, advertising drugs and cosmetics for people" article 3. The he, she: Chief, Chief Inspector, Director of the Vietnam drug administration, Director of treatment, Director of the service in the Health Ministry Of Vietnam General Director, Director of the Health Department of the province, the central cities of health and heads of departments, heads of relevant units responsible for the implementation of this decision.
 

 



Ministers (signed) Nguyen Phuong Parking REGULATION INFORMATION DRUG ADS for MEN, cosmetics DIRECT IMPACT to HUMAN HEALTH (attached to decision No. 2557/2002/QD-BYT on 4/7/2002 of the Minister of health) Chapter 1: GENERAL PROVISIONS article 1. Drugs used for cosmetic effect, people directly to human health (hereinafter referred to as the drug and cosmetics) is the kind of special goods, directly affect human health. So the ad information of medicines, cosmetics must be truthful, objectively accurate in order to guide the use of drugs, cosmetics are reasonably safe, consistent with national policies in Vietnam on the drug.
Article 2. Scope and objects 1. Adjustment range a) is the Ministry of Health issued the registration number circulating in Vietnam are advertising information for medical officers b) Smoking is not yet allowed to circulate in Vietnam but were allowed to circulate in other countries was the medical officer for information through workshop c) Medication buy sale, no need of a physician are advertising to the public information on books, newspapers, leaflets and on other advertising media.
d) are the main active ingredients are in the category are advertising to the public on radio and television by the Ministry of Health issued publicly advertised on radio and television.
e) is located in the cosmetics category by the Ministry of health to manage 2. Objects held, personal drug business, cosmetics or authorized units are active participants of information drug ads, according to the provisions of this regulation.
Article 3. In this regulation a of the term here is understood as follows: 1. drug information is a document of appointment, contraindications, dosage, unwanted effects, prevention when used for special groups of people (children, pregnant women, breastfeeding women, the elderly and other objects). The information should be considered in connection with clinical trials of the drug. Drug information is a reference document on the basis of the information already prescribed, the patient information and relevant documents.
2. drug information activity is the activity provides information on smoking of the unit, the individual responsible for drug information to meet the information requirements of the facilities, individuals are direct medical practice, pharmacy or by users.
3. Drug ads include the activities introduced by drug manufacturers, drug distribution directly conduct or distribute or sponsor, authorize an other unit conducted to promote the prescription, supply, sale and/or the use of drugs on the basis of rational drug use.
4. Drug ads for health officials is the active drug ads for those with professional qualifications of medical, pharmacy.
5. The introduction of the drug's medicinal business units on the territory of Vietnam are the unit assigned the task of introducing the drug for medical officers.
6. drug advertising to the public on the other advertising media is the advertising activities are conveyed on the media have not mentioned in this regulation.
7. The Seminar introduced the drug is a living science to introduce drugs or thematic discussion on one or a number of issues related to drugs for medical officers. The workshop introduced the drug because the unit contacts the organization or coordination and/or sponsor a Vietnam's medical institutions.
8. cosmetic advertising including referral activities, inform, promote a cosmetic about the name, features, effects etc. to help users choose and use the right products and promote the process of production, sale and/or using cosmetics.
Article 4. The content of information, products, advertisements must ensure objectivity, accurate, honest, and clear science.
Article 5. Information operations unit, advertising drugs, cosmetics, who directly provide drug information products shall bear responsibility for the content of the information provided and information activities, drug ads, her cosmetics.
Chapter 2: information, DRUG ADS for the drug information article 6 I.. The Ministry of health, the Department of health, the central cities, health industry, pharmaceutical, medical facility is responsible for the Organization, join the drug information activities within the profession in management unit.
Article 7. The only drugs business unit provides information on smoking is full of scientific facts have been proven. Source, origin of the information, the person providing the information, the time of providing the information must be clear.
Article 8. Medical officer only received official information about the drug from the unit is provided with information about the drug or the drug information according to the report template has been defined.
Article 9. The Ministry of health (the Vietnam pharmaceutical Management Bureau) the Department of health of the province of the central cities (hereafter referred to collectively as the Health Department) performs the function of State management of drug information.
Article 10. The business units are responsible for monitoring and timely reporting on the Vietnam pharmaceutical Management Bureau (QLDVN) the new information is discovered by a drug compared with the information already in the registration records of the drug, the declining quality of expression of the smoking, harmful effects of smoking by the business unit.
Article 11. Treatment facility, the medical officer is responsible for tracking and reporting the quality defects of the drug, making the harmful reactions of smoking on the heart monitor harmful drug reactions (ADR).
II. Ad article 12 pills. The content used to advertise a drug must fit with the following documents: 1. use manual has been the Ministry of health or equivalent governing body of the country, which allow the production, circulation and that drugs approved.
2. a treatise on drugs that have been recorded in the national mail Pharmacy or in the documents on the drug have been internationally recognized.
Article 13. In the drug ads, do not have the following behavior: 1. Use of material or financial benefits in any form to affect drug users, physician to promote the prescription, the use of drugs.
2. Taking advantage of register allow circulation of QLDVN Bureau to drug ads.

3. Use the name, logo, images, units of the drug or medicine, organization of medical officers to advertising, we recommend the use of drugs.
4. Using the mail type, clinical study results are not yet enough scientific basis, not enough medical evidence to drug ads.
5. In the name of medication, dosage, the advertising content of a medicine bag (the packaging off the sidelines smoking) to retail establishments for use as envelopes for the drug to the patient.
6. the advantage of testing results, medal by the Expo for the product. ... in the drug ads.
7. To distribute or to place drug retailers to distribute to the public those information materials, advertising drugs used for medical officers.
A. drug ads for medical officer article 14. Advertising content for medical officers include the following information: 1. name the drug.
-Special pharmacy Name (by the manufacturer)-international non-proprietary Name (INN) or the original name (Generic name) 2. Name of active ingredient: called follow the international nomenclature does not have copyright or original name 3. Manufactured formula 4. Dosage 5. Specify 6. How to use 7. Side effects and harmful response 8. Contraindications and things to 9. 10. Drug interactions Name and address of the manufacturer, wholesale smoking 11. Catalogue of documents has been used refer to article 15. The active form of the drug ads for medical officers.
1. Through "The introduction of the drug".
2. Release the drug advertising material 3. The workshop introduced the drug.
4. Exhibits, introducing smoking conferences, seminars for medical cadres.
Article 16. Drug ads for medical officers through the introduction of drugs.
1. introduction of the standard drugs.
a. is the pharmacist, or physician (for medicine), or medical herbalists, salaries (for traditional medicine).
b. has been recruiting training units, training and the Department of health of generation (where the closed unit headquarters) check, confirm.
-Have sufficient knowledge of the drugs which they assigned referrer, there is understanding of the law, the regulation of pharmacy related.
-Card People introduce drugs.
c. have full health and not being prejudice to criminal responsibility.
2. The liability of the drug introduction: a. just introduced these drugs that they are recruiting units assigned.
b. just introduced the smoking was allowed to circulate in VIETNAM and just introduced the drug information has been browse QLDVN Bureau.
c. when the works introduced the drug to wear the tag "People introduce drugs" and must be the consent of recipients of information new drug be conducted to introduce the drug.
d. collect the reports of harmful reactions, reports related to the quality of the drugs to reflect promptly with the unit that they represent. The unit is responsible for synthesizing and report on the Department of health (QLDVN).
Article 17. The case of The introduction of smoking would like to introduce the drug activity in a local (from the province that the introduction of the drug card) must then be approved by the local health department where they intended to introduce the drug.
Article 18. The introduction of the drug not be used physical benefits to cause emotional, convinced the medical officers prescribe, drug consumption by their units, not sell drugs or drug consignment form.
Article 19. The unit is responsible for recruiting and training, send records to the Department of health to check the card level, "Who introduced the drug" and must comply with the current rules of the State of the responsibility of the employer.
Article 20. The rights and responsibilities of the medical basis for the introduction of drugs: 1. check the implementation responsibility of the introduction of the drug has been prescribed in item 2 article 16 of this regulation.
2. The head of the Department of health reviews the practical needs and conditions of the unit to the specific provisions on the composition, location, time to The introduction of the drug be conducted to introduce the drug to medical officers in his unit.
3. operational review of The introduction of the drug. The case of The introduction of the pill violates this regulation must suspend the right operation of The introduction of the drug in his unit and reported violations of The introduction of the drug with the Health Department.
Article 21. Released promotional material for medical staff 1. All forms of advertising of drugs for medical officers must be drafted according to the provisions of article 14 of this regulation.
2. the documents and quotations to illustrate the advertising content retrieved from the magazine, reports science ... to be honest, update and specify the document name, author name, time published material.
3. Brochures, advertisements for medical officers must have the words "material used for medical officers" at the top of all pages. For those documents include many pages, the first page must specify the section details on products viewed in page (specific page numbers) and print clearly: (a) the number of votes received the registration record advertising department QLDVN and (b) the day, month, year in the document.
4. Brochure, advertisements for medical staff only valid 1 year from when printing, release. After one year the unit would like to continue to introduce, drug ads have to register again.
Article 22. The workshop introduced the drug for medical staff 1. Just hosted a workshop to introduce the drug was granted a registration number that allows circulating in Vietnam or were allowed to produce, circulate in other countries.
2. Introduce each drug products in the workshop must be fully the following: a. the name of the drug:-special pharmacy Name (by the manufacturer).
-Copyright International Name or the name of the root.
b. the amount/concentration of the active ingredient.
c. form d. e. pharmacokinetics pharmacodynamics clinical information: f. specify; dosage; How to use; contraindications; things to beware, note when using; side effects; harmful reaction and processing; interactions between the drugs; cases of overdose and how to handle.
g. information on dosage: dosage formulations; preserving; term of use; packing.
h. information on the classification of drugs like: poison, drugs, drugs, drugs sold by mental direction, sell does not need a doctor's application.
i. name, address of the manufacturer. Name, home address, wholesale.
3. The report of the workshop is the professional staff have extensive experience using the drugs were introduced.
4. for units, alien drug business would like to open a seminar introducing smoking to Vietnam in collaboration with a medical unit in Vietnam such as: hospitals, Medical Institute, training medical personnel, business establishments, smoking, occupational medicine, pharmacy associations such as the society of Pharmacology , The society for traditional medicine, medicinal Association Vietnam 5. Within 10 days after the end of the workshop the workshop organization unit must submit the written report of the results of the workshop to the Health Department of the province (where the unit register the content workshops) Article 23. Galleries flock introduced smoking Conference, Conference of medical officers: 1. The Unit organized, chaired the Conference, workshops like to introduce smoking, featured during the Conference, the Conference must be notified in writing to the Department of health at (which hosts the Conference, workshop) 2. All activities of drug ads, referral units have featured drug swarms in conferences, workshops are in accordance with the provisions of this regulation and other provisions of the law.
Article 24. Funding for conferences of medical officers to the unit, the individual is entitled to funding, the material for the meeting of the medical staff but must ensure the following conditions: 1. The sponsor must be on a voluntary basis, and with no conditions attached.
2. The use of funding in accordance with the current regulations of the Government of Vietnam

3. All activities of drug advertising, introduction of the sponsor at the Conference are in accordance with the provisions of this regulation and other provisions of the law.
The content has been defined in this also applies when the individual business units, drugs, and cosmetics sponsor for tv programs, radio.
B. drug ads to the public article 25. The advertising of medicines to the public 1. On books, newspapers, magazines, leaflets.
2. On the media television, Radio 3. Through Expo 4. On the mass media.
Article 26. The content, the image used in the ad for the public must be concise, common, consistent with the level of understanding of the masses. Do not use the sentences, words, images or sound triggers the following type of impression for the public.
-Use of this drug is the best remedies-Don't need the opinion of a physician-this drug totally harmless-this drug has no contra-indications, no side effects, harmful reaction ... Article 27. A drug ad content to the public must have the following information: 1. name-name of the miscellaneous (by the manufacturer)-the active ingredient or the original name (the name gerenic) 2. Specify 3. How to use 4. Contraindications and/or recommends in particular: for pregnant women who are breastfeeding, children, people with chronic diseases.
5. Things to avoid, note when using the medication 6. The name, the address of the manufacturing facility, drug distribution 7. The lyrics said "read carefully the user manual before use" in the case of drug advertising to the public on television, radio items 1, 2, 4 and 7 are read to, clearly Article 28. Not be advertised to the general public the addictive drug, poison, drugs, mental direction must prescribe medication, state management agencies have the authority recommended was not allowed to use or the use of physician supervision. Not be advertised as smoking products (food supplements) is not medicine. Not to be taken the following specified on an ad for the public: 1. Treatment of tuberculosis 2. Specifies the treatment of sexually transmitted diseases 3. My sister plan to treat severe infections or bacterial infection spread 4. My sister plan to treat chronic insomnia 5. The specified sexual characteristics 6. Indicated for the treatment of cancer, tumor diseases 7. Specifies the treatment of diabetes mellitus or other metabolic disorder diseases similar to Article 29. Drug advertising to the public on television, radio: 1. Ministry of Health announced the list of the main active ingredient in a drug advertised on television, radio, this category was added to adjust each time.
2. the following conditions are advertising on television, radio.
a) Have the main active substances is in the catalogue advertised on television broadcasting by the Ministry of Health issued b) as part of the active drug is located in the directory of poison, drug, drug addiction-causing mental direction according to the current regulation c) Have appropriate dosage and easy use d) article 30 stable quality. Drug ads through the fair, the exhibition 1. Only features the herds in the fair, the exhibition was the Ministry of health (QLDVN) registry.
2. Where'd featured swarms, introduced the smoking has not been the Ministry of health (QLDVN) the Windows registry or other advertising activities must be the Ministry of health (QLDVN) to consider and agree in writing.
Article 31. Drug advertising to the public on the other advertising media.
Only drug ads to the public on other advertising media when the media that convey content information prescribed in paragraphs 1, 2, 4, 7 article 27 of this regulation and to ensure the regulations are relevant.
Article 32. The first page of the promotional materials for the public must be in: (a) the number of votes received the registration record advertising department QLDVN and (b) the date, month and year the document information. When supplemented, modified the promotional materials for the public, then the units must register again.
Chapter 3: the COSMETICS AD Article 33. Cosmetic advertising is done on the mass media such as radio, television, books, newspapers, magazines, brochures by the business unit cosmetics make or sponsor, authorize other units made.
Article 34. The information in the cosmetics ad must match the document proving the safety and efficacy of cosmetics.
Article 35. A cosmetics ad content to the public must have the following information: 1. name (set by the manufacturer) 2. Ingredients (outlined the major active decisions to cosmetic effects) 3. The effect (outlined the effects of cosmetics).
4. How to use (how to use true) 5. Things to avoid when using (stated things to avoid if there are, for example: do not use this cosmetics in addition to the Sun).
6. The name, address of cosmetics production unit.
When the cosmetic advertising on tv, radio media items 1, 3, 5 to be read to, obviously.
Article 36. The following acts prohibited in cosmetic advertising 1. The cosmetics ads not yet circulated in Vietnam 2. Those ads have not been proven to 3. Use the name and position of the Organization of the medical officer of health, personal credibility, the type of correspondence to cosmetic advertising activities 4. Form of advertising not consistent with American style, pure continue Vietnam 5. Use text, photos, sound triggers the following type of impression for the public: a) this is the No. 1 cosmetics, is better than all.
b) use this cosmetics is best measure c) cosmetic completely harmless, no side effects, no irritation, etc.
Article 37. The following products cannot be advertised to the general public: 1. Cosmetics under the skin 2. Cosmetics that use is likely to cause injury to the eyes, the ears, the desert 3. When used in cosmetics must have the guidance of a physician.
Chapter 4: PROCEDURE for RECEIVING INFORMATION, advertising the DRUG, cosmetic Articles 38. The Ministry of health (QLDVN) to receive, resolve registration profile information, drug ads and authorization for the Department of health made the following work: 1. check your level and the level of drug referral card 2. Of receiving and treating documents introductory workshop for medical officers in the province 3. Of receiving and treating documents cosmetics Ad Article 39. Profile, who intro card procedure smoking 1. To be issued the card who introduced the drug, pharmaceutical business unit in Vietnam records sent medical Facility where the unit headquarters or Representative Office 2. The card records introduced the drug include: a Single person card recommended) referral (form 1a) b) resumes (certified by the authorities or local authorities) c) a copy of a valid post-graduation d) health certificate e) catalog item is assigned referrer f) certificate of competence level, ethics after 15 working days from the date of receipt of a valid application, the Department of health to answer the unit in writing, no case-level tags must clearly state the reason 3. The Department of health is responsible for inspecting, evaluation, each person's knowledge under the provisions of this regulation before the introduction card. (Drug referral Card form 1b)
4. The card who introduced the drug worth 2 years from the date of issue to be given back "card people introduce drugs" unit shall submit the records before the card expires may 1. Units have people introduce drugs to recover and return the card who introduced the drug agency authority granted in the following cases: a) Who introduced the drug changed the work b) Who introduced the drug only the task of introducing the drug c) expired medication referral Card use

Article 40. Of receiving and treating documents workshops introduce smoking 1. The drug business unit in Vietnam before the Seminar introduced the drug for medical officers in the province would have to submit medical records.
2. The profile of drug introduction workshop for medical officers include: a) registration workshop introduced the drug for medical officers (form 2a) b) workshop program (expected).
c) contents of each report, the name and title of the scientific report.
d) material intended featured swarms released at the seminar e) relevant documents of smoking was introduced at the workshop f) The reference 3. All materials contained in the file are marked borders of establishment units 4. Upon receipt of the application, the Department of Health reported to the unit send a voucher of receiving profile (form 2b). On the day of the vote received on profile is getting medical records.
5. After 15 working days from the date of receiving documents, if the Health Department does not have the required text amendments, supplements, the unit was organized as the content submitted.
6. The case of the Department of health has required text amendments and supplements.
a) in the text require additional amendments are stated specifically, details: adds the document, modify content, adding content ... b) units are modified, supplemented in accordance with the content specified in the request text revisions, additions and posted on the Department of health content seminar has been modified and supplements. Receipt of additional amendments have been shown on the window to health. After 5 working days, counting from the date of the seminar contents were modified, supplemented if the Health Department does not have the required text amendments, supplements, the unit was organized as the content was modified.
7. The Unit sent records of registration the workshop responsible for prior notice (at least 7 days) for the Department of health to receive registration documents about a specific place and time officially organized the seminar.
Article 41. Of receiving and treating documents cosmetics ad 1. The business unit cosmetics in Vietnam want cosmetic ads must send advertisements about cosmetic Medical Facility (Where the unit headquarters).
2. cosmetic ads records including: a) Ad profile registration form (form 3a) b) form, contents (expected) will advertise my products. If advertising on television, radio must send scripts, videotapes, tape. The script must clearly describe the portion images, lyrics, music.
c) documents verifying the advertising content.
3. All materials contained in the file are marked borders of establishment units.
4. Upon receipt of the application, the Department of health will inform the unit to send a vote of receiving profile (form 3b). On the day of the vote received on profile is getting medical records.
5. After 15 working days from the date of receiving documents if the Health Department does not have the required text amendments, supplements, the unit is right to advertise as the content submitted.
6. The case of the Department of health has required text amendments and supplements: a) in the text require additional amendments are stated specifically, details: adds the document, modify content, adding content ... b) units are modified, supplemented in accordance with the content specified in the requested text revisions , the addition of the Department of health and Department of health sent the advertising content has been modified and supplemented. The date the profile was modified and supplemented is shown on the window to health. After five working days from the date of receiving the advertising content has been modified and supplemented if the Health Department does not have the required text amendments, supplements, the unit was advertised as the content was modified.
7. In the case of units have additional amendments but not according to the content outlined in the text requires amendment, addition of the Department of health, the Department of health will assess the registration records and the register of records not yet advertised the content submitted. In this case, the Department of health will inform the unit to send a receipt of votes and profile evaluation cycle be repeated from the beginning.
8. Within 10 days after the release, print promotional materials register ad profile to submit: 2 publications (case of advertising on books, newspapers, magazines, flyers ...) or 2 tapes (tv ads) or 2 casset tapes (audio ads) about the health department where receiving the ad profile. Publications, video casset tape, posted on the Department of health must have the same content, with the form of publications, videotapes, tape casset was advertising and must have the signature verification, stamp of the sending unit.
Article 42: receiving and treating documents information drug ads.
1. The business unit smoking Vietnam want to drug ads must send the registration records of the Ministry of health drug ads (QLDLVN) 138A Giang Vo, Hanoi. Envelopes contain records stating: the registration profile information, drug ads.
2. Records of information drug ads include: a) registration profile information, drug ads (form 4a) b) form, contents (expected) will advertise the drug. Advertising on television, radio must send the draft scripts, videotapes, tape. The script must clearly describe the portion images, lyrics, music.
c) documents verifying the advertising content.
d) sheets of manual medicine was browsing have QLDVN their stamp Bureau.
e) The reference 3. All materials contained in the file are marked borders of establishment units.
4. Upon receipt of the registration application, the QLDVN Bureau will notify the unit send a voucher of receiving profile (form 4b). On the day of the vote received on profile is QLDVN Bureau received profile.
5. After 15 working days from the date of receiving a valid profile if the QLDVN Bureau does not have the required text amendments, supplements, the unit is right to advertise as the content submitted.
6. The case of QLDVN Bureau has requested text revisions, supplements a) request in writing amendments and supplements are stated specifically, details: adds the document, modify content, adding content ... b) units are modified, supplemented in accordance with the content specified in the text require modification supplements and QLDVN Bureau send advertising content has been modified and supplemented. Receipt of additional amendments have been shown on the window to Bureau of QLDVN. After 5 working days from the date of receiving the advertising content was modified, supplemented if no text QLDVN Bureau requires additional amendments it was advertised as the content was modified.
7. In the case of units have modified, supplemented but not according to the content outlined in the text requires amendment, addition of the QLDVN, the QLDVN Bureau Bureau will assess the registration records and the register of records not yet advertised the content submitted. In this case the QLDVN Bureau will notify the sending unit by receiving one vote profile profile and profile evaluation cycle be repeated from the beginning.
8. In the past 10 days since the release of the documents, print drug ads units ad profile registration must submit: publications (case of advertising on books, newspapers, magazines, flyers ...) or 2 tapes (tv ads) or 2 casset tapes (audio ads) about the QLDVN Bureau. Publications, videotapes, tape casset posted about QLDVN Bureau must have the same content, with the form of publications, videotapes, tape casset was advertising and must have the signature verification, stamp of the sending unit.

43 things. For the unit is authorized to conduct or cosmetics advertising information, drug ads of a another unit in addition to the documents specified in article 41, article 42 of this regulation should be more authoritative paper of cosmetics production unit or units owned registry of smoking it.
Article 44. Information materials, medicines, cosmetics ad out value in the following cases: 1. the registry has expired.
2. withdraw the registration of Drugs or medication, cosmetic state management agencies have the authority recommended was not allowed to use.
3. the change in information for drugs or cosmetics.
Individual units have documented information, advertising drugs, cosmetics expired value is responsible for the notification and recall.
Chapter 5: PROCESSING of breach of article 45. The unit, the violation of these rules, depending on the level of violation will be suspension or administrative sanction or withdraw the registry of drug items in violation or arrested save for criminal liability in accordance with the law.
Chapter 6: Article 46 ENFORCEMENT TERMS. These rules are effective from the date of 04/07/2002 and replaced the regulation of information, advertising drugs and cosmetics for people attached to decision No. 322/BYT-QĐ dated 28/02/1997 of the Ministry of health.
Article 47. The units and individuals within and outside the health sector (even units, foreign individuals) are practicing medicine, pharmacy or activities in the field of information, advertising. The units have drugs, cosmetics are the Ministry of health for travelling in Vietnam, the units and individuals involved in information activities, advertising drugs, cosmetics on the territory of Vietnam is responsible for enforcement of this regulation.
Article 48. Vietnam pharmaceutical Management Bureau, Inspector of the Ministry of health, the Department of health, health care industry his responsibility to guide the Organization examined, inspected the implementation of this regulation.
The Association, the professions of medicine, medicinal herbs enhance the advocacy, mobilization, education, monitoring units, the members of his organization in the implementation of this regulation.
 
 

PPC/HO CHI MINH CITY health department number: .../the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness WORKSHOP PROFILE RECEIVING VOTES, about SMOKING medical city............ receiving registration workshop, introducing the smoking numbers: (record of the vote registration workshop, introducing the smoking of the unit).
Of units: (write the name of the profile registration unit).
Address: (address of the profile registration unit).
Phone: (write your phone number registration unit).
The date of the workshop registration records, introducing smoking: day/month/year.
The number of votes received: ***/hai * last number of years receiving records/QCMP.
The name province/city, day ... month ... year ....
Heads of unit (specify title) (signature, stamp) and the name of the person signing.
Form 1a of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness CARD APPLICATION PEOPLE INTRODUCE DRUGS dear: Department of health province (City)............
1. The name of the unit sent to introduce smoking: 2. Address: 3. Phone numbers, Fax, E-mail: 4. The number of active licenses of the unit: 5. List of recommended level cards: The introduction of the drug name, date/STT/birth professionalism of residence at 6. (Write the name of the filing) commitment has and will organize a training class, training and regular training for the people who introduced the drug (1) knowledge of drugs which they will introduce and (2) The relevant professional regulations.
7. Please submit this form: ă copies of diplomas or certificates as defined in article 16 of the regulations.
ă ă each resume health certificate by certificate of competence ă, level, quality, ethics of each person.
On ... ... ... ... ... ... in 200 ...
Heads of unit (name, stamp).
Specify signer name.
Model 1b TEMPLATE TAG PEOPLE INTRODUCE DRUGS DRUG REFERRAL CARD (1) full name, professional level (2) name of owner (3) cards have a value to the end of the day.../.../... (3) the Department of health province (1) signer title (3) numbers:. ../SYT-QLD (3) sign your name and last name of person signing (3) photos (3 x 4) seal notes: @ 5.5 x 9.0 cm card size Font and the font size + @ (1): VnTimeH, 10, bold + (2): VnTime, 14, bold + (3): VnTime, 10 cards PEOPLE INTRODUCE DRUGS (1) DS. Nguyen Huy Hung Great Northern company valuable Card to the end on 12/02/02 of the HANOI Health Department Deputy Director: 12/SYT-QLD sign Nair Family Photo (3 x 4) seal the form 2a of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness WORKSHOP PROFILE REGISTRATION , GIỚI THIỆU THUỐC
Số:.............................................................
Dear medical city........
1. registration unit name: 2. Address: 3. Phone numbers, Fax, E-mail: 4. The number of active licenses: 5. name, Surname, phone number of the person or the Department responsible for registration: 6. list of registered drugs seminar for health officials: the number of SUSPECTED drug registration number Name of object 1 2 3 7th seminar. Location and time scheduled seminar: 8. submit documents:-workshop program (expected).
-The content of each report.
-Material intended for display, introduced at the workshop.
-The reference.
9. The commitment of the unit drug workshop registration: we have researched information regulation, advertising for medicines and cosmetics directly to human health are attached to decision No............./2002/QD-BYT of the Minister of health, and are committed to comply with the provisions of regulation because of the health and interests of the patient.
The name province/city, day ... month ... year ...
Heads of unit (specify title) (signature, stamp) and the name of the person signing.
Form 3a of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness REGISTRATION Cosmetics AD PROFILE:..........................................
Dear medical city........
1. registration unit name: 2. Address: 3. Phone numbers, Fax, E-mail: 4. The number of active licenses: 5. name, telephone number of the person or the Department responsible for registration: 6. list of registered cosmetic advertising.

STT cosmetic registration number or Name of the vote to receive a published standard of quality HH of cosmetics advertising 1 2 3 7th. The materials include:-content (expected) of each ad.
-The document verifying the advertising content of each cosmetic.
8. The commitment of American advertising subscription products.
We have studied carefully the information regulations, advertising for medications and cosmetics directly to human health are attached to decision No............./2002/QD-BYT of Minister of health and committed to compliance with the regulations the regulations because of the health and interests of the user.
The name province/city, day ... month ... year ...
Heads of unit (specify title) (name, stamp) full name of the registrant.


PPC/HO CHI MINH CITY health department number: .../the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness of RECEIVING VOTES the AD PROFILE COSMETIC medical city............ receiving registration documents of cosmetics ads: (write the registration number of votes the ad profile of cosmetics units).
Of units: (write the name of the profile registration unit).
Address: (address of the profile registration unit).
Phone: (write your phone number registration unit).
The date of the registration dossier for cosmetics ad: day/month/year.
The number of votes received: ***/hai * last number of years receiving records/QCMP.
The name province/city, day ... month ... year ...
Heads of unit (specify title) (signature, stamp) and the name of the person who signed the form 4a of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness REGISTRATION PROFILE information, DRUG ADS:.............................................
Dear Vietnam pharmaceutical Management Bureau 1. Registration unit name: 2. Address: 3. Phone numbers, Fax, E-mail: 4. The number of active licenses: 5. name, Surname, phone number of the person or the Department responsible for registration: 6. list of registered medicines information, promotion: STT drug registration number Name and object forms TT , QC



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7. The materials include:-expected information content, advertising of each drug.
-The document verifying the advertising content of each drug.
-A copy of active content license to practice.
8. The commitment of the unit register information, drug ads: we have researched information regulation, advertising for medicines and cosmetics directly to human health are attached to decision No......../2002/QD-BYT of the Minister of health, and are committed to comply with the provisions of regulation because of the health and interests of the patient.
The name province/city, day ... month ... year ...
Heads of unit (specify title) (signature, stamp) and the name of the person signing.
Form 4b MOH VIETNAM PHARMACEUTICAL MANAGEMENT BUREAU (Bureau of QLDVN hanging seal) of the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness of RECEIVING VOTES the AD PROFILE SMOKING Vietnam drug administration took over the record number of drug ads: registration (registration number records records of drug ad unit).
To: (name registration unit).
Address: (address of the profile registration unit).
Phone: (write your phone number registration unit).
The date of the registration records drug ads: day/month/year.
The number of votes received: ***/hai * last number of years receiving/QLD-TT.
T. L DIRECTOR of VIETNAMESE DRUG ADMINISTRATION CHIEF QLTT, QC of MEDICINES-cosmetics (signature, stamp) and name of person signing