Code of sales PReMA 2010

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Code of sales PReMA 2010 11/30/10, 2:12 PM 1

Transcript of Code of sales PReMA 2010

Code of sales PReMA 2010 11/30/10, 2:12 PM1

  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠  “ √ ∫— ≠

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§”π”........................................................................................................ 4

§«“¡‡ªìπ¡“............................................................................................. 4

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1 𑬓¡....................................................................................................... 6

2 À≈—°°“√................................................................................................... 8

3 ¢âÕ°”Àπ¥∑—Ë«‰ª ¢Õß°“√∑”°“√μ≈“¥.................................................... 10

4 «‘∏’°“√ à߇ √‘¡°“√μ≈“¥.......................................................................... 14

4.1 º≈‘μ¿—≥±å........................................................................................ 14

4.2 √“§“................................................................................................ 14

4.3 °“√ à߇ √‘¡º≈‘μ¿—≥±å..................................................................... 14

4.3.1 °“√‚¶…≥“μ“¡ ◊ËÕ∑—Ë«‰ª....................................................... 16

4.3.2 °“√ à߇ √‘¡°“√¢“¬‚¥¬μ√ß∂÷ߺŸâ∫√‘‚¿§................................ 20

4.3.3 °“√ à߇ √‘¡°“√¢“¬‚¥¬μ√ß∂÷ߺŸâª√–°Õ∫°“√√â“π§â“............ 20

4.3.4 °“√‡º¬·æ√à‚¶…≥“·≈–ª√–™“ —¡æ—π∏å................................ 22

4.4 ºŸâ·∑π‡«™¿—≥±å................................................................................ 24

4.5  ∂“π∑’Ë·≈–°“√®—¥®”Àπà“¬............................................................. 24

5 °“√∫√‘À“√............................................................................................... 24

6 °“√ªØ‘∫—μ‘μàÕ¢âÕ√âÕ߇√’¬π........................................................................ 26

7 °“√·∑√°·´ß........................................................................................... 30

8 «—π∑’Ë¡’º≈ªØ‘∫—μ‘........................................................................................ 30

Code of sales PReMA 2010 11/30/10, 3:58 PM2

C O N T E N T SC O N T E N T S

Section Page

INTRODUCTION.............................................................................. 5

BACKGROUND............................................................................... 5

COMMITMENTS OF PHARMACEUTICAL RESEARCH AND

MANUFACTURERS ASSOCIATION (PReMA)............................... 5

1 DEFINITIONS................................................................................... 7

2 PRINCIPLES.................................................................................... 9

3 GENERAL PROVISION APPLICABLE TO ALL MARKETING

PRACTICES..................................................................................... 11

4 METHODS OF PROMOTION.......................................................... 15

4.1 Product.................................................................................... 15

4.2 Price......................................................................................... 15

4.3 Promotion............................................................................. 15

4.3.1 Advertising Though General Media........................ 17

4.3.2 Direct Advertising to Consumer.............................. 21

4.3.3 Direct Promotion to Drugstore Operators.............. 21

4.3.4 Advertising and Public Relations Practices........... 23

4.4 Sales Representatives ........................................................ 25

4.5 Location and Product Distribution..................................... 25

5 ADMINISTRATION........................................................................... 25

6 COMPLAINTS PROCEDURE.......................................................... 27

7 SANCTIONS..................................................................................... 31

8 OPERATIVE DATE........................................................................... 31

Code of sales PReMA 2010 11/30/10, 2:12 PM3

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√–‡∫’¬∫§«∫§ÿ¡Õ¬à“߇¢â¡ß«¥ ‡ªìπÕÿμ “À°√√¡∑’ËμâÕß„™âß∫ª√–¡“≥≈ß∑ÿπ∑’Ë Ÿß„π°“√«‘®—¬æ—≤π“·≈–®”‡ªìπμâÕßæ—≤π“π«—μ°√√¡º≈‘μ¿—≥±å„À¡à Ê Õ¬à“ßμàÕ‡π◊ËÕß §«∫§Ÿà‰ª°—∫§«“¡‡ªìπ‡≈‘»„π¥â“π°“√¢“¬·≈–°“√μ≈“¥

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¥â“π°“√Õπ“¡—¬¢Õß¡«≈¡πÿ…¬å ‚¥¬°“√§‘¥§âπ«‘®—¬·≈–æ—≤𓇫™¿—≥±å Õÿª°√≥å ·≈–‡§√◊ËÕß¡◊Õ∑“ß°“√·æ∑¬å™π‘¥„À¡àÊ √«¡∂÷ß°“√º≈‘μ·≈–∑”°“√μ≈“¥º≈‘μ¿—≥±å∑’Ë¡’§ÿ≥¿“懪ìπ∑’ˇ™◊ËÕ∂◊Õ·≈–‡ªìπ‰ªμ“¡¡“μ√∞“π°“√ªØ‘∫—μ‘∑’Ë¥’∑’ˇªìπ∑’ˬա√—∫„π√–¥—∫ “°≈

Code of sales PReMA 2010 11/30/10, 2:13 PM4

5PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

PReMA CODE OF SALES & MARKETING PRACTICES FORDRUGSTORE, DRUGSTORE OPERATOR AND DRUGSTORE OPERATOR

WHO SELLS PHARMACEUTICAL PRODUCTS 3rd EDITION, 2011

IntroductionPharmaceutical Research & Manufacturers Association (PReMA) repre-

sents companies who are engaged in the research and development, manufac-turing, trading or importing of pharmaceutical products. Membership, as ordinarymembers, associate members or honorary members, is open to companies whoare registered in accordance with the law of the Kingdom of Thailand.

BackgroundThe pharmaceutical industry is distinct from other industries in that it is

highly regulated, requires expensive up front investment in research, anddepends on constant product innovation and excellence in sales and marketing.

All companies shall be fully cognisant of the activities that they aresupporting and must critically examine these activities to ensure they meet thefollowing criteria:

❒ Enhance medical knowledge to the drugstore operators in order tobenefit to the consumers,

❒ Enhance the quality use of medicines,❒ Do not bring discredit to the industry,❒ Can successfully withstand public, professional and community

scrutiny,❒ Conform to professional and community standards.The voluntary adoption of this Code is in accordance with the key

objectives of the Association as set out in Section 40 of the PReMA Articles ofAssociation.

An important feature of this Code is that ALL members voluntarily acceptto observe and adhere to the provisions of the Code as a condition of theirmembership with the Association.

COMMITMENTS OF PHARMACEUTICAL RESEARCH & MANUFAC-TURERS ASSOCIATION (PReMA)

Members of PReMA are committed to the improvement of the health ofmankind through research and development of new medicines/devices and theproduction and marketing of pharmaceutical products of reliable quality, inaccordance with internationally defined standards of good practice.

Code of sales PReMA 2010 11/30/10, 2:13 PM5

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¥â«¬æ—π∏°‘®∑’Ë¡’μàÕ°“√ √â“߇ √‘¡ ÿ¢¿“æ∑’Ë¥’  ¡“™‘° ¡“§¡®÷ß¡’¿“√–Àπâ“∑’Ë·≈–§«“¡√—∫º‘¥™Õ∫„π°“√„Àâ¢âÕ¡Ÿ≈·≈–§«“¡√Ÿâ∑’Ë∂Ÿ°μâÕ߇°’ˬ«°—∫º≈‘μ¿—≥±å¢Õßμπ·°àºŸâª√–°Õ∫°“√√â“π§â“‡æ◊ËÕ„À⇰‘¥§«“¡‡¢â“„®™—¥‡®π‡°’ˬ«°—∫°“√„™â¬“·≈–‡¿ —™¿—≥±åÕ¬à“ß∂Ÿ°μâÕß·≈–‡À¡“– ¡

 ¡“™‘°®–μâÕߥ”‡π‘π°‘®°√√¡ à߇ √‘¡º≈‘μ¿—≥±å (°“√ªØ‘∫—μ‘∑“ß°“√μ≈“¥) ¥â«¬¡“μ√∞“π∑“ß®√‘¬∏√√¡¢—Èπ Ÿß °“√„Àâ¢âÕ¡Ÿ≈‡°’ˬ«°—∫º≈‘μ¿—≥±å ®–μâÕßÕ¬Ÿà„π≈—°…≥–∑’ˇªìπ°“√™à«¬ºŸâª√–°Õ∫°“√√â“π§â“ æ—≤π“∫√‘°“√∑’Ë„Àâ°—∫ºŸâªÉ«¬„À⥒¢÷Èπ·≈–‡ πÕ¢âÕ¡Ÿ≈¥â«¬§«“¡‡ªìπ°≈“߇ªìπ®√‘ß ·≈–¥â«¬°√–∫«π°“√𔇠πÕ∑’ˇÀ¡“– ¡ ·≈– Õ¥§≈âÕß°—∫°ÆÀ¡“¬·≈–√–‡∫’¬∫¢âÕ∫—ߧ—∫∑’ˇ°’ˬ«¢âÕß °“√Õ«¥Õâ“ß √√æ§ÿ≥·≈–«‘∏’„™â¢Õߺ≈‘μ¿—≥±å®–μâÕß„™âÀ≈—°∞“π∑“ß«‘∑¬“»“ μ√å∑’ˬ◊π¬—π‰¥â ¢âÕ¡Ÿ≈¥â“πº≈¢â“߇§’¬ß ·≈–Õ“°“√‰¡àæ÷ߪ√– ß§å ¢âÕÀâ“¡„™â ·≈–¢âÕ§«√√–«—ß ®–μâÕß𔇠πե⫬§«“¡™—¥‡®π

Õπ÷Ëß  ¡“™‘°®–º¥ÿ߉«â´÷Ë߇°’¬√μ‘»—°¥‘Ï·Ààß«‘™“™’槫∫§Ÿà‰ª°—∫°“√ªØ‘∫—μ‘μ“¡À≈—°‡°≥±å∑“ß°“√¢“¬·≈–°“√μ≈“¥π’È

1. 𑬓¡1.1 §”«à“ ç ¡“§¡é À¡“¬∂÷ß  ¡“§¡ºŸâ«‘®—¬·≈–º≈‘μ‡¿ —™¿—≥±å1.2 §”«à“ çÀ≈—°‡°≥±åé À¡“¬∂÷ß À≈—°‡°≥±å∑“ß°“√¢“¬·≈–°“√μ≈“¥ ”À√—∫

 ¡“™‘°μàÕ√â“π§â“¢Õß ¡“§¡ ºŸâ«‘®—¬·≈–º≈‘μ‡¿ —™¿—≥±å1.3 §”«à“ ç à߇ √‘¡º≈‘μ¿—≥±åé À¡“¬∂÷ß °‘®°√√¡∑“ß°“√μ≈“¥·≈–¢âÕ¡Ÿ≈¢à“« “√∑’Ë

®—¥À√◊Õ ‚¥¬¡’®ÿ¥¡ÿàßÀ¡“¬„À⇰‘¥°“√ —Ëß„™â¬“∑’ˇªìπ‡¿ —™¿—≥±å¢ÕߺŸâ¥”‡π‘π°“√ Õ’°∑—È߬—ß√«¡∂÷ß°‘®°√√¡„πÀπâ“∑’Ë¢ÕߺŸâ·∑π‡«™¿—≥±å¢Õß∫√‘…—∑ ·≈–«‘∏’°“√ à߇ √‘¡°“√¢“¬„π√Ÿª·∫∫μà“ß Ê ‡™àπ°“√„Àâ¢âÕ¡Ÿ≈º≈‘μ¿—≥±å„π∑ÿ°√Ÿª·∫∫ °‘®°√√¡°“√ª√–™“ —¡æ—π∏å °“√‚¶…≥“∑“ß ◊ËÕÕ‘‡≈§‚∑√π‘° å ◊ËÕπ‘μ¬ “√/ ‘Ëßæ‘¡æå·≈– ◊ËÕ∂÷ß°≈ÿࡇªÑ“À¡“¬‚¥¬μ√ß∑“߉ª√…≥’¬å °“√ÕÕ°√â“πÀ√◊Õ‡¢â“√à«¡„ππ‘∑√√»°“√ °“√„™â‚ μ∑—»πŸª°√≥å ‡™àπ  ◊ËÕ‡∑ª∫—π∑÷°‡ ’¬ß ¿“æ¬πμ√å ·ºàπ‡ ’¬ß ¿“æπ‘Ëß·≈–«’¥’∑—»πåÕÿª°√≥å· ¥ß¢âÕ¡Ÿ≈∑“߮Ղ∑√∑—»πåÀ√◊Õ‡§√◊ËÕß©“¬¿“æª√–‡¿∑Õ◊Ëπ μ≈Õ¥®π°“√·®°μ—«Õ¬à“ߺ≈‘μ¿—≥±å„Àâ∑¥≈Õß °“√„Àâ¢Õߢ«—≠ ·≈–°“√®—¥°“√μâÕπ√—∫À√◊Õ√—∫√Õß ·μà∑—Èßπ’ȉ¡à§√Õ∫§≈ÿ¡∂÷ß°“√ª√–°“»‡ª≈’Ë¬π¿“™π–À’∫ÀàÕ §”‡μ◊Õπ∂÷ߺ≈¢â“߇§’¬ß °“√‡√’¬°‡°Á∫¬“§◊π ∑’ˉ¡à‡ªìπ°“√∫Õ°·®âß √√æ§ÿ≥¬“„𧔪√–°“»π—Èπ

1.4 §”«à“ 燿 —™¿—≥±å√â“π§â“é μ“¡À≈—°‡°≥±åπ’È À¡“¬∂÷ß º≈‘μ¿—≥±å ”‡√Á®√Ÿª ‡¿ —™‡§¡’¿—≥±å º≈‘μ¿—≥±å°≈ÿà¡™’««—μ∂ÿ∑’Ë„™â„π°“√«‘π‘®©—¬ ∫”∫—¥ ∫√√‡∑“√—°…“ À√◊ÕªÑÕß°—π‚√§ À√◊Õ§«“¡‡®Á∫ªÉ«¬¢Õß¡πÿ…¬å ´÷Ëß¡’°“√ à߇ √‘¡º≈‘μ¿—≥±å

1.5 §”«à“ 纟âª√–°Õ∫°“√√â“π§â“é „Àâ¡’§«“¡À¡“¬§√Õ∫§≈ÿ¡∂÷ߺŸâ√—∫Õπÿ≠“μ ºŸâ¥”‡π‘π°“√ ·≈–ºŸâ¡’Àπâ“∑’˪ؑ∫—μ‘°“√„π√â“π§â“π—ÈπÊ

Code of sales PReMA 2010 11/30/10, 2:13 PM6

7PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

As a part of their commitment to healthcare, PReMA members have anobligation and responsibility to provide accurate information and education abouttheir products to healthcare providers and users in order to establish a clearunderstanding of the appropriate use of the medicines/pharmaceutical products.

Promotional activities (marketing practices) must be conducted with highethical standards. All product information shall be designed to help drugstoreoperators improve service to patients. Information must be provided with objec-tivity, truthfulness and in good taste and must conform to all relevant laws andregulations. Claims for therapeutic indications and conditions of use must be basedon valid scientific evidence. Clear statements with respect to side effects, contra-indications, and precautions shall be included.

High standards of ethical behavior and conduct shall apply equally tomarketing of pharmaceutical products.

1. DEFINITIONS1.1 The term “Association” or “PReMA” means the Pharmaceutical

Research & Manufacturers Association.1.2 The term “Code” means Code of Sales & Marketing Practices for

Drugstore, Drugstore Operator and Drugstore Operator who Sells Pharmaceuti-cal Products of the Pharmaceutical Research & Manufacturers Association.

1.3 The term “product promotion” refers to the marketing and informa-tional activities undertaken, organized or sponsored by a pharmaceuticalcompany with the objective to encourage the prescribing of its pharmaceuticalproducts. The term also includes the activities of sales representatives and allother aspects of sales promotion in whatever form they may occur. Examples ofpromotion include but are not limited to: product information presented in anyform; public relation activities; advertising via electronic media, journal/print anddirect mail; participation in exhibitions; use of audio cassettes, films, records,slides, tapes and video recordings; the use of any other data storage and viewingdevices reproduced on television; visual display units; the provision of samples,gifts and hospitality. However, it does not extend to announcement of the changeof packaging, side effect warning, product recall, in which no properties beinginformed.

1.4 The term “pharmaceutical product for drugstore channel” accordingto this Code means any ready-to-use product, pharmaceutical chemistry, rangeof any biological product used in diagnosis, relief, treatment, and protection ofhuman illness, which is being promoted.

1.5 The term “drugstore operators” shall refer those licensed and/orhaving duties by law at such drugstores.

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1.6 §”«à“ 纟â·∑π‡«™¿—≥±åé À¡“¬∂÷ß æπ—°ß“π¢Õß∫√‘…—∑∑ÿ°√–¥—∫ ∑’Ë∑”Àπâ“∑’Ëμ‘¥μàÕ·≈–‡ πÕ‡¿ —™¿—≥±åμàÕºŸâª√–°Õ∫°“√√â“π§â“

1.7 §”«à“ ç‡Õ° “√°”°—∫¬“é À¡“¬∂÷ß ‡Õ° “√¢âÕ¡Ÿ≈‚¥¬≈–‡Õ’¬¥‡°’ˬ«°—∫‡¿ —™¿—≥±å∑’ˉ¥â√—∫°“√Õπÿ¡—μ‘®“° ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ °√–∑√«ß “∏“√≥ ÿ¢·≈–‰¥â∫√√®ÿÀ√◊Õ√«¡‰«â°—∫‡¿ —™¿—≥±å∑ÿ°À’∫ÀàÕ

1.8 ª√–‡¿∑¢Õß ¡“™‘° ¡“§¡ºŸâ«‘®—¬·≈–º≈‘μ‡¿ —™¿—≥±å1.8.1  ¡“™‘° “¡—≠ ‰¥â·°à π‘μ‘∫ÿ§§≈∑’ˇªìπ∑’Ë√Ÿâ®—°‡™◊ËÕ∂◊Õ ´÷Ë߇ªìπºŸâº≈‘μ À√◊Õ

ª√–°Õ∫°“√§â“ À√◊Õ‡ªìπºŸâπ”‡¢â“ ‘π§â“ª√–‡¿∑¬“À√◊Õ‡¿ —™¿—≥±å ·≈–‰¥â¬◊Ëπ§”¢Õ‡ªìπ ¡“™‘°·≈–‰¥â√—∫Õπÿ≠“μ®“°§≥–°√√¡°“√¢Õß ¡“§¡·≈â«π‘μ‘∫ÿ§§≈∑’Ë®¥∑–‡∫’¬π„π·≈–μ“¡°ÆÀ¡“¬¢Õßμà“ߪ√–‡∑» ´÷Ëߪ√–°Õ∫°‘®°“√º≈‘μ §â“¢“¬ À√◊Õπ”‡¢â“¬“À√◊Õ‡¿ —™¿—≥±å„πª√–‡∑»‰∑¬ ‰¡à«à“‚¥¬μπ‡ÕßÀ√◊Õ‚¥¬ºà“π∫ÿ§§≈Õ◊Ëπ °Á¡’ ‘∑∏‘‡ªìπ ¡“™‘° “¡—≠¢Õß ¡“§¡¥â«¬

1.8.2  ¡“™‘° ¡∑∫ ‰¥â·°à π‘μ‘∫ÿ§§≈ À√◊Õ ∫ÿ§§≈∏√√¡¥“∑’ˇªìπ∑’Ë√Ÿâ®—°‡™◊ËÕ∂◊Õ ´÷Ë߇°’ˬ«¢âÕß°—∫Õÿμ “À°√√¡‡¿ —™¿—≥±å ·μà‰¡à¡’ ‘∑∏‘ ¡—§√‡ªìπ ¡“™‘° “¡—≠Õ¬à“߉√°Á¥’ ∫ÿ§§≈∏√√¡¥“´÷Ë߇°’ˬ«¢âÕßÀ√◊Õ¡’ à«π√à«¡„π°‘®°“√¢Õßπ‘μ‘∫ÿ§§≈∑’Ë¡’ ‘∑∏‘‡ªìπ ¡“™‘° “¡—≠Õ¬Ÿà·≈â« ‰¡à¡’ ‘∑∏‘∑’Ë®–‡ªìπ ¡“™‘°„π∞“π–∫ÿ§§≈∏√√¡¥“Õ’°

1.8.3  ¡“™‘°°‘μμ‘¡»—°¥‘Ï ‰¥â·°à ∫ÿ§§≈∏√√¡¥“∑’ˉ¥â„À⧫“¡™à«¬‡À≈◊ÕÕ¬à“ß¡’§à“μàÕ°“√æ—≤π“¥â“π ÿ¢Õπ“¡—¬„πª√–‡∑»‰∑¬ μàÕ«ß°“√Õÿμ “À°√√¡‡¿ —™¿—≥±å À√◊ÕμàÕ ¡“§¡

2. À≈—°°“√À≈—°‡°≥±å©∫—∫π’È¡ÿàßÀ¡“¬∑’Ë®– √â“ß·≈–√—°…“‰«â´÷Ëß¡“μ√∞“π Ÿß ÿ¥¢Õß°“√¥”‡π‘π°“√

∑“ß°“√μ≈“¥μàÕ√â“π§â“À≈—°‡°≥±åπ’È Õ¥§≈âÕß·≈– π—∫ πÿπ°ÆÀ¡“¬·≈–ª√–°“»μà“ßÊ ¢Õß∑“ß√“™°“√∑’Ë¡’Õ¬Ÿà

·≈–∑’Ë°”≈—ß®–μ√“‡ªìπ°ÆÀ¡“¬À≈—°‡°≥±åπ’ȇªìπ¢âժؑ∫—μ‘ ”À√—∫°“√§«∫§ÿ¡μπ‡Õß ´÷Ëß®–™’Èπ” ¡“™‘°∂÷ß¡“μ√∞“π

 Ÿß ÿ¥·Ààß°“√¬÷¥¡—Ëπ¢ÕßÀ≈—°°“√ §«“¡√—∫º‘¥™Õ∫ ·≈–®√‘¬∏√√¡„π°“√ª√–°Õ∫Õ“™’æ¢ÕßÕÿμ “À°√√¡·¢πßπ’È

2.1 „π°“√ à߇ √‘¡º≈‘μ¿—≥±å ¢âÕ¡Ÿ≈‡°’ˬ«°—∫‡¿ —™¿—≥±å∑’Ë𔇠πÕμàÕºŸâª√–°Õ∫°“√√â“π§â“μâÕ߇∑’ˬß∏√√¡ ‡ªìπ∏√√¡ ·≈–‡ªìπ —μ¬å®√‘ß ·≈–§«√‡ªìπ‰ªμ“¡À≈—°∞“π∑“ß«‘™“°“√§√—Èß≈à“ ÿ¥∑’ˉ¥â√—∫Õπÿ¡—μ‘®“°§≥–°√√¡°“√Õ“À“√·≈–¬“ „πª√–‡∑»‰∑¬·≈â«

Code of sales PReMA 2010 11/30/10, 2:13 PM8

9PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

1.6 The term “Sales Representatives” means employees of the com-

pany at all levels responsible for contact and presentation of its pharmaceutical

products to the drugstore operators.

1.7 The term “certified package insert” means comprehensive product

information included in each product pack as approved by the Food and Drug

Administration (FDA) of the Ministry of Public Health.

1.8 Categories of PReMA Membership include:

1.8.1 Ordinary Members, are Juristic persons of good standing

who are manufacturers, traders or importers of medicines or other pharmaceuti-

cal products and who have applied to become members and have been approved

by the Board of Directors of PReMA. Juristic Persons incorporated in and under

the laws of other countries which manufacture, trade, or import medicines or other

pharmaceutical products in Thailand either directly or through other parties are

also entitled to become Ordinary Members of the Association.

1.8.2 Associate Members, are Juristic persons or natural persons

of good standing who have association with the pharmaceutical industry but who

are not eligible for Ordinary Membership. However, persons associated with a

business or who take part in the activities of any company which is eligible for

membership as a Juristic person shall not be eligible for a membership as a

natural person.

1.8.3 Honorary members are natural persons who have rendered

valuable services to the development of healthcare in Thailand the pharma-

ceutical industry, or the Association, PReMA.

2. PRINCIPLESThis Code aims to create and maintain highest standard of marketing

practices in drugstore channel. These practices are in line and support various

existing laws and regulations and also those to be existed.

This Code entails self-regulatory approaches, of which shall direct towards

highest standard of principle-oriented, responsibility and ethics of the industry.

2.1 In the course of product promotion, information pertaining to the

pharmaceutical product presented to drugstores shall be accurate, fair and fac-

tual. Such information shall be according to the latest reference as approved by

the Thai FDA.

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2.2  ¡“™‘°®–μâÕ߉¡à¡’°“√≈–‡¡‘¥‡§√◊ËÕßÀ¡“¬°“√§â“ À√◊Õ ≈‘¢ ‘∑∏‘Ï¢ÕߺŸâÕ◊Ëπ∑’Ë®¥∑–‡∫’¬πÕ¬à“ß∂Ÿ°μâÕß„π√“™Õ“≥“®—°√‰∑¬

2.3  ¡“™‘°μâÕ߉¡à· «ßÀ“º≈ª√–‚¬™π宓°°“√§ÿ⡧√ÕßÕ—π®”°—¥¢Õßæ√–√“™∫—≠≠—μ‘ ‘∑∏‘∫—μ√„πª√–‡∑»‰∑¬ ‚¥¬‡ªìπº≈‡ ’¬À“¬μàÕ‡®â“¢Õß ‘∑∏‘∫—μ√ À√◊ÕºŸâ‰¥â√—∫Õπÿ≠“μ„Àℙ⠑∑∏‘´÷Ë߬—ß∂◊Õ«à“‡ªìπ‡®â“¢Õß∑√—æ¬å ‘π∑“ߪí≠≠“¥—ß°≈à“«‚¥¬™Õ∫∏√√¡„πª√–‡∑»μâπ°”‡π‘¥º≈‘μ¿—≥±å

2.4  ¡“™‘°®–μâÕß√—∫º‘¥™Õ∫„π°“√Ωñ°Õ∫√¡æπ—°ß“π∑’ˇ°’ˬ«¢âÕß°—∫ß“π à߇ √‘¡º≈‘μ¿—≥±å„À—‰¥â√—∫§«“¡√Ÿâ∑“ß°“√·æ∑¬å·≈–¥â“π«‘™“°“√‡æ’¬ßæÕ∑’Ë®–‡ πÕ¢âÕ¡Ÿ≈º≈‘μ¿—≥±å¢Õß∫√‘…—∑Õ¬à“ß∂Ÿ°μâÕߥ⫬§«“¡√—∫º‘¥™Õ∫·≈–¡’®√√¬“∫√√≥ æπ—°ß“π®–μâÕßπ”º≈ –∑âÕπ®“°ºŸâª√–°Õ∫°“√√â“π§â“‡¿ —™¿—≥±å∑’Ë¡’μàÕ°“√„™âº≈‘μ¿—≥±å‚¥¬‡©æ“–º≈¢â“߇§’¬ß„π°“√„™â¬“¡“√“¬ß“π∫√‘…—∑

2.5  ¡“™‘°æ÷ß®—¥„Àâ¡’°√–∫«π°“√∑’ˇÀ¡“– ¡‡æ◊ËÕ à߇ √‘¡°“√ªØ‘∫—μ‘μ“¡À≈—°‡°≥±å·≈–À¡—Ëπμ‘¥μ“¡μ√«® Õ∫∑ÿ°°‘®°√√¡·≈–Õÿª°√≥å∑’Ë„™â„π°“√ à߇ √‘¡°“√¢“¬¢Õßμπ

2.6 À≈—°‡°≥±åπ’È ‡ªìπ¢âժؑ∫—μ‘∑’Ëæ÷ß¡’„π¡‚π ”π÷° ‡™àπ‡¥’¬«°—∫∑’ˉ¥â∫—≠≠—쑉«â‡ªìπ≈“¬≈—°…≥åÕ—°…√

2.7 °“√„À⧫“¡‡§“√æ ·≈–Õ¬Ÿà„πÕ“≥—μ‘¢ÕßÀ≈—°‡°≥±å∑“ß°“√μ≈“¥π’ȇªìπ‡ß◊ËÕπ‰¢Àπ÷Ëß·Ààß°“√¥”√߉«â´÷Ëß ¡“™‘°¿“æ°—∫ ¡“§¡ºŸâ«‘®—¬·≈–º≈‘μ‡¿ —™¿—≥±å °“√≈–‡¡‘¥À√◊Õ≈–‡≈¬μàÕÀ≈—°‡°≥±å®–¡’∫∑≈ß‚∑…∑“ß«‘π—¬μàÕ ¡“™‘°ºŸâΩÉ“Ωóπμ“¡∑’Ë°”À𥉫â

3. ¢âÕ°”À𥂥¬∑—Ë«‰ª¢Õß°“√ªØ‘∫—μ‘∑“ß°“√¢“¬°“√μ≈“¥3.1 °“√ªØ‘∫—μ‘∑“ß°“√¢“¬·≈–°“√μ≈“¥ μâÕ߉¡àπ”¡“´÷Ëߧ«“¡‡ ◊ËÕ¡‡ ’¬μàÕ

Õÿμ “À°√√¡¬“3.2 ¢âÕ¡Ÿ≈‡°’ˬ«°—∫º≈‘μ¿—≥±å∑’Ë®—¥„À⺟âª√–°Õ∫°“√√â“π§â“ μâÕ߇ªìπ¢âÕ¡Ÿ≈ªí®®ÿ∫—π

∂Ÿ°μâÕß ‡∑’ˬßμ√ß ·≈–μâÕ߉¡à°àÕ„À⇰‘¥§«“¡‰¢«â‡¢«À√◊Õ‡¢â“„®º‘¥ ‚¥¬«‘∏’°“√ √–∫ÿ Õÿª‰¡¬ μ—¥∑Õπ À√◊ÕμàÕ‡μ‘¡∂âÕ¬§Ì“ ·≈–μâÕßæ√âÕ¡∑’Ë®–®—¥¢âÕ¡Ÿ≈∑“ß«‘™“°“√ π—∫ πÿπ°“√Õâ“ß √√æ§ÿ≥À√◊Õ§”·π–π”„Àâ„™âº≈‘μ¿—≥±å∑’ˉ¥â√—∫°“√Õπÿ¡—μ‘®“° ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“„À⺟âª√–°Õ∫°“√√â“π§â“À“°‰¥â√—∫°“√√âÕߢÕ

3.3 „π°“√Õâ“ßՑ߇հ “√∑“ß°“√·æ∑¬åÀ√◊Õ°“√ ◊ËÕ “√®“°ºŸâ«‘®—¬∑“ߧ≈‘π‘° (clinical in-vestigators) æ÷ßμâÕß°√–∑”¥â«¬§«“¡√–¡—¥√–«—ßÕ¬à“ß Ÿß‡æ◊ËÕ„Àâ¡—Ëπ„®«à“‰¡à¡’°“√∫‘¥‡∫◊Õ𧫓¡À¡“¬∑’Ë·∑â®√‘ß®“°¢âÕ¡Ÿ≈∑’ˇªìπμâπ©∫—∫

3.4 æ÷ß≈–‡«âπ°“√Õâ“ßÕ‘ß„π‡™‘ß≈∫À≈Ÿà‡¿ —™¿—≥±åÀ√◊ÕºŸâº≈‘μÕ◊Ëπ3.5 ‰¡à„™â§”∑’Ë¡’§«“¡À¡“¬„π≈—°…≥–«à“‡Àπ◊Õ°«à“ ‡ªìπ∑’Ë ÿ¥ ‚¥¬‰¡à “¡“√∂æ‘ Ÿ®π剥â

‰¡àÕ«¥Õâ“ß«à“º≈‘μ¿—≥±åÀ√◊Õμ—«¬“ «à“‡ªìπ‡¿ —™¿—≥±å çÀπ÷Ë߇¥’¬«é (´÷ËßÀ¡“¬§«“¡«à“‡ªìπ ‘Ëß·√°

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11PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

2.2 All trademark duly registered in the Kingdom of Thailand must be

respected and copyrights observed by member.

2.3 No member shall seek to benefit from the limited protection

provided to pharmaceutical patents in the Kingdom of Thailand, at the expense of

the discoverer, or his licensee, who remains rightful owner of such property in

the originating country.

2.4 It is the responsibility of all members to ensure that all relevant

company personnel are adequately trained and possess sufficient medical and

technical knowledge to present information on their company’s products in an

accurate, responsible and ethical manner. They must also feedback to their

company, from contacts with the drugstore operator, information which they re-

ceive on the use of products and particularly reports on side effects.

2.5 Members shall organize effective procedures to promote and

encourage the compliance of the Code, as well as monitor all activities and

materials used in the promotional activities.

2.6 This Code is to be applied in the spirit as well as in the letter.

2.7 The respect and observance to this Code is a condition in maintain-

ing membership with the Association. Violation or ignorance of the Code shall

subject to disciplinary penalties as stipulated.

3. GENERAL PROVISION APPLICABLE TO ALL MARKETINGPRACTICES

3.1 Marketing Practices shall never be such as to bring about discredit

to the pharmaceutical industry.

3.2 Information of the product provided to the drugstore operators shall

be current, accurate, balanced and shall not be misleading either directly, by im-

plication, by omission or addition. Scientific data to support the claims and rec-

ommendations for use, as approved by the FDA, shall be made available, on

request, to drugstore operators.

3.3 In quoting from medical literature, or from the communications of

clinical investigators, special care shall be taken to ensure that the meaning of

the original information, taken as a whole, is not distorted.

3.4 Members shall refrain from discrediting other parties’ references.

3.5 Unqualified superlatives must not be used. Claims must not imply

that a product or an active ingredient is unique (“unique” means being the first,

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·≈– ‘Ë߇¥’¬« À√◊Õ·μ°μà“ß®“°º≈‘μ¿—≥±å∑—ÈßÀ≈“¬ À√◊Õ‡ªìπÀπ÷Ë߇¥’¬«¢Õ߬“°≈ÿà¡π—ÈπÊ „πμ≈“¥ª√–‡∑»‰∑¬) À√◊ÕÕâ“ß √√æ§ÿ≥摇»…„¥ Ê ‚¥¬ª√“»®“°À≈—°∞“π π—∫ πÿπ ·≈–°“√Õπÿ¡—μ‘®“° ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ Àâ“¡„™â§”«à“ çª≈Õ¥¿—¬é „π°“√ à߇ √‘¡°“√¢“¬Õ¬à“ß≈Õ¬Ê ‚¥¬ª√“»®“°∫ÿ§§≈À√◊Õ ‘Ëß∑’ËÕâ“ßՑ߉¥â (‡™àπ „Àâ°≈à“««à“ μ“¡À≈—°∞“π..../‡Õ° “√À√◊ÕºŸâÕâ“ßÕ‘ß...∂◊Õ«à“¡’§«“¡ª≈Õ¥¿—¬„π°“√„™â)

3.6 μâÕßæ÷ß —ß«√‡ªìπ摇»…∑’Ë®–‰¡à≈–‡≈¬„π°“√𔇠πÕ¢âÕ¡Ÿ≈‡°’ˬ«°—∫§«“¡ª≈Õ¥¿—¬¢âÕÀâ“¡„™â º≈¢â“߇§’¬ß·≈–§«“¡‡ªìπæ‘… μàÕæπ—°ß“π‡®â“Àπâ“∑’Ë ·≈–ºŸâª√–°Õ∫°“√√â“π§â“ ‡æ◊ËÕ§«“¡ Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥¢â“ßμâπ  ‘Ëßæ‘¡æ傶…≥“μà“ß Ê ¬°‡«âπ‚¶…≥“¬àÕμ“¡¢âÕ 3.7§«√μ’æ‘¡æå¢âÕ¡Ÿ≈¥—ßμàÕ‰ªπ’È

❒ ™◊ËÕ “√ÕÕ°ƒ∑∏‘Ï À√◊Õ μ—«¬“ ”§—≠ ‚¥¬„™â™◊ËÕ‡√’¬° “°≈ (International NonproprietaryNames (INN) À√◊Õ™◊ËÕ “¡—≠∑“߬“∑’ˉ¥â√—∫Õπÿ¡—μ‘·≈â«

❒ ™◊ËÕ°“√§â“❒ ª√‘¡“≥ “√ÕÕ°ƒ∑∏‘ÏμàÕ¢π“¥√—∫ª√–∑“π À√◊Õ ¢π“¥μàÕÀπ૬∫√√®ÿ (Regimen)❒ ™◊ËÕ¢Õß “√ª√–°Õ∫Õ◊Ëπ∑’ËÕ“®¡’º≈‡ ’¬μàÕºŸâ„™â¬“❒ ¢âÕ∫àß„™â„π°“√∫”∫—¥√—°…“∑’ˉ¥â√—∫Õπÿ¡—μ‘·≈â«❒ √Ÿª·∫∫¢Õ߬“ ·≈–¢π“¥°“√„™âμàÕ§√—Èß❒ º≈¢â“߇§’¬ß ·≈–Õ“°“√‰¡àæ÷ߪ√– ß§å®“°°“√„™â¬“❒ ¢âÕ§«√√–«—ß ¢âÕÀâ“¡ ·≈–§”‡μ◊Õπ❒ ªØ‘°‘√‘¬“∑’ˇ°‘¥¢÷Èπ√–À«à“ßμ—«¬“ (Õ—πμ√°√‘¬“)❒ ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕߺŸâº≈‘μ ºŸâπ”‡¢â“·≈–ºŸâ®—¥®”Àπà“¬❒ °“√Õâ“߇հ “√ ‘Ëßæ‘¡æå«‘™“°“√∑’ˇ™◊ËÕ∂◊Õ‰¥âμ“¡§«“¡‡À¡“– ¡❒ ‡≈¢∑’ˉ¥â√—∫Õπÿ≠“μ®“° ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ „πª√–‡∑»‰∑¬

¿“¬À≈—ß„Àâ°“√√—∫√Õ߇π◊ÈÕÀ“¢Õ߇հ “√ à߇ √‘¡°“√¢“¬‚¥¬¢âÕ¡Ÿ≈∑—ÈßÀ¡¥®–æ‘¡æåÕ¬Ÿà„π‡Õ° “√ à߇ √‘¡º≈‘μ¿—≥±å ‡Õ° “√π’È®–π”¡“„™â‰¥â

¿“¬„π™à«ß‡«≈“∑’ˉ¥â√—∫Õπÿ≠“μ®“° ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“‡∑à“π—Èπ3.7 πÕ°‡Àπ◊Õ®“°¢âÕ·π–π”„πÀ≈—°‡°≥±å¢â“ßμâπ ¬—ß¡’¢âÕ°”Àπ¥°“√∑”‚¶…≥“¬àÕ¥—ßπ’È

‚¶…≥“¬àÕ‡ªìπ ◊ËÕ°“√‚¶…≥“Õ¬à“ßÀπ÷Ëß´÷ËßÕ“®®–¡’¢âÕ§«“¡„¥¢âÕ§«“¡Àπ÷Ëߥ—ßμàÕ‰ªπ’È ™◊ËÕ°“√§â“™◊ËÕ “°≈∑’ˉ¡à„™à™◊ËÕ°“√§â“ (INN) °“√Õâ“ßÕ‘ß∂÷ߢâÕ∫àß„™â À√◊Õ°≈ÿà¡ √√æ§ÿ≥¬“ ¢âÕ§«“¡ çμ‘¥μàÕ¢Õ√“¬≈–‡Õ’¬¥‡æ‘Ë¡‡μ‘¡‰¥â∑’Ëé æ√âÕ¡∑—Èß· ¥ß‡§√◊ËÕßÀ¡“¬ª√–®”∫√‘…—∑ (Logo) ·≈–∑’ËÕ¬Ÿà„πª√–‡∑»∑—Èßπ’ÈμâÕ߇ªìπ‰ªμ“¡√–‡∫’¬∫‡√◊ËÕß°“√‚¶…≥“¢Õß ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“

3.8 À“°‡Õ° “√°”°—∫¬“¡’∑—Èß¿“…“‰∑¬·≈–¿“…“Õ—ß°ƒ… ¢âÕ§«“¡∑—Èß Õß¿“…“μâÕß

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13PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

different from all others and the only one of its class in the Thai market), or has

some special merit, quality or property unless such a claim can be substantiated

and also approved by the FDA. The word ‘Safe’ must not be used in promotion,

without qualification (i.e. it shall mentioned “according to evidence.../document

or reference ... shall be considered to be safe).

3.6 Particular care shall be taken that essential information on any phar-

maceutical products’ safety, contra-indications, side effects or toxic hazards is

properly communicated to the Thai regulatory authorities and to drugstore

operators. To comply with the above, in all printed promotional materials (with the

exception of reminder (short) advertisements, as mentioned under 3.7), the

following list of information shall be printed:

❒ the name(s) of the active ingredient(s) using either international non-

proprietary names (INN) or the approved generic name of the drug;

❒ the brand name;

❒ content of active ingredient(s) per dosage form or regimen;

❒ name of other ingredients known to cause problems;

❒ approved therapeutic uses;

❒ dosage form or regimen;

❒ side-effects and major adverse drug reactions;

❒ precautions, contra-indications and warnings;

❒ major interactions;

❒ name and address of manufacturer, importer or distributor;

❒ reference to credible scientific literature as appropriate;

❒ approval number, granted by Thai FDA after approving the contents

of the promotional material, shall be printed on all promotional materials.

All information shall be printed on the promotional material, of which can be used

only during the validity period of the FDA approval.

3.7 In addition to the recommendations in the Code, special rules apply

to ‘reminder advertisements’. A reminder advertisement is an advertisement which

presents only the trade name, the INN (International Non-proprietary Name), a

reference to the indication or the therapeutic class, the sentence ‘Further infor-

mation available through ...’, the company logo and local address as per the FDA

regulation on advertising.

3.8 When certified package inserts are required by the Thai FDA to be

Code of sales PReMA 2010 11/30/10, 2:13 PM13

14 À≈—°‡°≥±å∑“ß°“√¢“¬·≈–°“√μ≈“¥ ©∫—∫∑’Ë 3, 2554

μ√ß°—π πÕ°®“°®–‡ªìπ°“√‡ª≈’ˬπ·ª≈ß‚¥¬ ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“‡∑à“π—Èπ3.9 ∫√‘…—∑ ¡“™‘°§«√®—¥∑”°√–∫«π°“√„π°“√√“¬ß“πÕ“°“√Õ—π‰¡àæ÷ߪ√– ß§å®“°

°“√„™â¬“ ·≈–°“√‡√’¬°‡°Á∫¬“§◊π‚¥¬„À⺟â·∑π‡«™¿—≥±å·≈–æπ—°ß“π∑’Ë¡’ à«π‡°’ˬ«¢âÕ߉¥â√—∫∑√“∫π‚¬∫“¬¢Õß∫√‘…—∑·≈–¢—ÈπμÕπ„π°√–∫«π°“√¥—ß°≈à“«

3.10  ¡“™‘°μâÕߥŸ·≈„Àâ¡—Ëπ„®«à“ æπ—°ß“π„πÕߧå°√¢Õß ¡“™‘° À√◊ÕÕߧå°√∑’ˉ¥â√—∫¡Õ∫Õ”π“®„Àâ°√–∑”°“√·∑π ¡“™‘° (‡™àπ μ—«·∑π‚¶…≥“ ºŸâ√—∫®â“ߺ≈‘μ ·≈–ºŸâ·∑π®”Àπà“¬)μ√–Àπ—°¥’„πÀπâ“∑’Ë·≈–§«“¡√—∫º‘¥™Õ∫∑’ËμâÕߪؑ∫—μ‘μ“¡À≈—°‡°≥±å∑“ß°“√μ≈“¥¢Õß ¡“§¡

3.11  ¡“™‘°§«√·μàßμ—Èßæπ—°ß“π∫√‘À“√√–¥—∫ ŸßÕ¬à“ßπâÕ¬Àπ÷Ëß∑à“π„πÕߧå°√‡æ◊ËÕ„Àâ¡’Õ”π“®·≈–Àπâ“∑’Ë√—∫º‘¥™Õ∫‚¥¬μ√ßμàÕ°“√ªØ‘∫—μ‘μ“¡À≈—°‡°≥±åπ’È À“°¡’°“√≈–‡¡‘¥À≈—°‡°≥±å„π¢âÕ„¥ À√◊Õ¡’°“√ª√–æƒμ‘º‘¥ À√◊Õ„Àâ¢âÕ‡∑Á®®√‘ß∑’ˉ¡à∂Ÿ°μâÕß‚¥¬æπ—°ß“π§π„¥¢Õß ¡“™‘°  ¡“™‘°®–μâÕß√—∫º‘¥™Õ∫μàÕ°“√·°â‰¢„Àâ∂Ÿ°μâÕß

4. «‘∏’°“√ à߇ √‘¡°“√μ≈“¥4.1 º≈‘μ¿—≥±å

4.1.1 ‡¿ —™¿—≥±å√â“π§â“ μâÕ߇ªìπ‡¿ —™¿—≥±å∑’˺≈‘μ·≈–§«∫§ÿ¡§ÿ≥¿“æμ“¡À≈—° “°≈‡æ◊ËÕ„Àâ¡—Ëπ„®«à“¡’§ÿ≥¿“æ ª√– ‘∑∏‘º≈ ·≈–§«“¡ª≈Õ¥¿—¬„π°“√ªÑÕß°—π √–ß—∫ ∫√√‡∑“·≈–∫”∫—¥Õ“°“√‡®Á∫ªÉ«¬„π¢—Èπμâπ‰¥â

4.1.2 ‡¿ —™¿—≥±å√â“π§â“ ‡ªìπ‡¿ —™¿—≥±å∑’Ë„™â‡æ◊ËÕ°“√∫”∫—¥‚√§¥â«¬μπ‡ÕßÀ√◊Õ‡ªìπ‡¿ —™¿—≥±å∑’Ë„™âμ“¡§”·π–π”¢ÕߺŸâ¡’Àπâ“∑’˪ؑ∫—μ‘°“√„π√â“π§â“·≈–À√◊Õ‡¿ —™¿—≥±å∑’Ë®à“¬μ“¡„∫ —Ëß·æ∑¬å´÷Ëß´◊ÈÕ¢“¬ À√◊Õ‡√’¬°¢“π°—π¥â«¬™◊ËÕ°“√§â“ ‡§√◊ËÕßÀ¡“¬°“√§â“ ™◊ËÕºŸâº≈‘μÀ√◊Õ —≠≈—°…≥å∑“ß°“√§â“Õ◊ËπÊ

4.1.3 °≈àÕß∫√√®ÿ¿—≥±å ©≈“° ·≈–‡Õ° “√°”°—∫¢Õ߇¿ —™¿—≥±å√â“π§â“μâÕß¡’¢âÕ§«“¡·≈–√Ÿª¿“æ∂Ÿ°μâÕß ·≈–μ√ßμ“¡∑’ˉ¥â¢÷Èπ∑–‡∫’¬π‰«â°—∫ ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ·≈–∂Ÿ°μâÕßμ“¡À≈—°‡°≥±å∑“ß°“√μ≈“¥¢Õß Àæ—π∏å ¡“§¡ºŸâº≈‘쬓π“π“™“μ‘(International Federation of Pharmaceutical Manufacturers Associations - IFPMA)

4.2 √“§“4.2.1 √“§“®”Àπà“¬ª≈’°Àπâ“°≈àÕߢÕ߇¿ —™¿—≥±å√â“π§â“§«√‡ªìπ√“§“‡¥’¬«°—π

∑—Ë«ª√–‡∑»4.2.2 „π°“√‡ª≈’ˬπ·ª≈ß√“§“‡¿ —™¿—≥±å  ¡“™‘°μâÕߪؑ∫—μ‘μ“¡°Æ√–‡∫’¬∫

¢ÕßÀπ૬ߓπ√“™°“√∑’Ë°”°—∫¥Ÿ·≈4.3 °“√ à߇ √‘¡º≈‘μ¿—≥±å

ç°“√‚¶…≥“¢“¬¬“é À¡“¬∂÷ß °“√°√–∑”„π≈—°…≥–„¥°Áμ“¡„π°“√‡º¬·æ√à¢âÕ¡Ÿ≈‡°’ˬ«°—∫º≈‘μ¿—≥±å

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15PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

printed and provided in the Thai and English languages, the information impartedin both languages shall be the same unless text is changed by the FDA.

3.9 All members shall have an established procedure for reportingadverse drug reaction and product recall. All sales representatives and otherappropriate staff shall be made fully aware of the company’s internal policies andprocedures.

3.10 Members shall ensure that own employees or those of authorizedorganizations [such as advertising agencies, contract manufacturers and distri-butors] very well realize of their duties and responsibilities under the Code.

3.1 Members shall appoint at least one high ranking management toauthorize and take direct responsibility according to this Code. All members shallassume responsibility for correcting breaches of the Code resulting from miscon-duct or misrepresentation of facts by any representative.

4. METHOD OF PROMOTION4.1 Product

4.1.1 The pharmaceutical products for drugstore channel shall bemanufactured and controlled according to international standard to ensure thatthey render quality, efficacy and safety to prevent, relieve and cure the primarystages of ailment.

4.1.2 The pharmaceutical products for drugstore channel are forself-medication, used under recommendations of pharmacists on duty in drug-stores and/or dispensed according to doctorís prescription or those called by tradename, trademark, manufacturer’s name or other commercial signs.

4.1.3 Package, label and leaflet of pharmaceutical product for drug-store channels shall contain messages and pictures identical with those regis-tered with the FDA and in compliance with to the Code of the International Fed-eration of Pharmaceutical Manufacturers Associations

4.2 Price4.2.1 The retail (sticker) price of the pharmaceutical product for drug-

store channel should be the same throughout the country.4.2.2 Changes in the price shall be compatible with rules and regula-

tions of supervisory government agencies.4.3 Promotion

“Medicine advertising” means any actions to circulate and distributeinformation about a product that fits the definition of “medicine”, through variousforms of advertising at present, advertising in direct sales, news releases about a

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´÷Ëß¡’≈—°…≥–μ√ß°—∫§”®”°—¥§«“¡§”«à“ ç¬“é ‚¥¬Õ“®¡’°“√¥”‡π‘π°“√ºà“π ◊ËÕ‚¶…≥“∑’Ë¡’„™â°—πÕ¬ŸàÀ≈“°À≈“¬√Ÿª·∫∫„πªí®®ÿ∫—π °“√‚¶…≥“ ‘π§â“„π√–∫∫¢“¬μ√ß °“√ÕÕ°¢à“«‡°’ˬ«°—∫º≈‘μ¿—≥±å¬“ ·≈–°“√‚¶…≥“„π√Ÿª·∫∫¢Õß°“√查¢Õß°“√‚¶…≥“„π√“¬°“√μà“ß Ê ‰¡à«à“°“√°√–∑”‡À≈à“π—ÈπºŸâ¥”‡π‘π°“√®–‰¥â√—∫°“√μÕ∫·∑πÀ√◊Õ‰¡à°Áμ“¡ À“°¡’«—μ∂ÿª√– ß§å‡æ◊ËÕª√–‚¬™πå∑“ß°“√§â“∂◊Õ‡ªìπ°“√‚¶…≥“

4.3.1 °“√‚¶…≥“μ“¡ ◊ËÕ∑—Ë«‰ª4.3.1.1 °“√‚¶…≥“‡¿ —™¿—≥±å√â“π§â“μâÕߪؑ∫—μ‘„Àâ∂Ÿ°μâÕßμ“¡°ÆÀ¡“¬

«à“¥â«¬¬“4.3.1.2 ¢âÕ§«“¡·≈–√Ÿª¿“æ∑’Ë‚¶…≥“μâÕ߇ªìπ‰ªμ“¡∑’ˉ¥â√—∫Õπÿ¡—μ‘®“°

 ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“4.3.1.3 °“√‚¶…≥“„π ◊ËÕμà“ßÊ μâÕß√–∫ÿ‡≈¢∑’Ë∑’ˉ¥â√—∫Õπÿ≠“μ≈ß„π ◊ËÕπ—Èπ

·≈–„™â„π™à«ß√–¬–‡«≈“∑’ˉ¥â√—∫Õπÿ≠“μ4.3.1.4 Àâ“¡‡º¬·æ√à À√◊Õ‚¶…≥“¬“Õ—πμ√“¬ À√◊Õ¬“§«∫§ÿ¡æ‘‡»…‚¥¬¡’

‡®μπ“·Õ∫·Ωߺà“π∑“ß ◊ËÕ∑—Ë«‰ª ‡™àπ ∑“ß√“¬°“√«‘∑¬ÿ À√◊Õ‚∑√∑—»πå À√◊Õ∫∑§«“¡„π ◊ËÕ ‘Ëßæ‘¡æ凪ìπμâπ

4.3.1.5 °“√‚¶…≥“‡¿ —™¿—≥±å√â“π§â“μâÕ߉¡à„™â∂âÕ¬§” À√◊Õ°“√· ¥ß∑’Ë°àÕ„À⇰‘¥§«“¡À«“¥°≈—«μàÕºŸâ™¡ ºŸâøíß À√◊ÕºŸâÕà“π «à“‡¢“‡À≈à“π—Èπ°”≈—߉¥â√—∫§«“¡∑ÿ°¢å∑√¡“π®“°§«“¡‡®Á∫ªÉ«¬À√◊Õ®–‰¥â√—∫§«“¡∑ÿ°¢å∑√¡“π®“°§«“¡‡®Á∫ªÉ«¬ À“°‰¡à‰¥â√—∫°“√√—°…“

4.3.1.6 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“«à“‡ªìπ¬“∑’Ë “¡“√∂„™âªÑÕß°—πÀ√◊Õ√—°…“‚√§√⓬·√ß‚¥¬¡‘μâÕßÕ¬Ÿà¿“¬„μâ°“√¥Ÿ·≈‡Õ“„®„ à¢Õß·æ∑¬å

4.3.1.7 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“„À⺟â∫√‘‚¿§‡°‘¥Õÿª∑“πμâÕßæ÷Ë߬“‡ªìπ∑“ßÕÕ°

4.3.1.8 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“¥â«¬ √√æ§ÿ≥∑’ËπÕ°‡Àπ◊Õ®“°¢âÕ∫àß„™â∑’ˉ¥â√—∫Õπÿ¡—μ‘∑–‡∫’¬π¬“

4.3.1.9 Àâ“¡„™â°“√‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‡ªìπ‡§√◊ËÕß¡◊Õ·Õ∫·Ωß„π°“√‚¶…≥“¬“Õ—πμ√“¬À√◊Õ¬“§«∫§ÿ¡æ‘‡»… ´÷ËßÀâ“¡‚¶…≥“μ“¡°ÆÀ¡“¬

4.3.1.10 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“«à“‡ªìπ¬“∑”„Àâ·∑âß≈Ÿ°À√◊Õ¬“¢—∫√–¥ŸÕ¬à“ß·√ß À√◊Õ¬“∫”√ÿß°“¡ À√◊Õ¬“§ÿ¡°”‡π‘¥ À√◊Õ‡ √‘¡ √â“ß ¡√√∂¿“æ∑“ß‡æ» À√◊Õ≈¥ ¡√√∂¿“æ∑“߇æ»∑’Ë¡’‡°‘π À√◊Õ√—°…“§«“¡‡®Á∫ªÉ«¬Õ◊ËπÕ—π‡°’Ë¬«°—∫«‘ —¬∑“߇æ»

4.3.1.11 °“√„™â§”«à“ ç∫”√ÿßé „π¢âÕ§«“¡‚¶…≥“§«√√–∫ÿ®ÿ¥¡ÿàßÀ¡“¬¢Õß°“√„™â‡¿ —™¿—≥±å„Àâ™—¥‡®πμ“¡ √√æ§ÿ≥∑’ˉ¥â√—∫Õπÿ¡—μ‘∑–‡∫’¬π¬“ ‚¥¬‰¡àÕ«¥Õâ“ßÀ√◊Õ ◊ËÕ„Àâ

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17PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

medicinal product, and reference of the product in any sort of show, whether theperson in action are compensated or not. If commercial purposes are served,such activities are considered ìadvertisingî.

4.3.1 Mass Media Advertising4.3.1.1 Advertising of pharmaceutical product for drugstore

channel must conform with the legal requirements set out in the Drug Act ineffect.

4.3.1.2 It shall conform both in text and illustration approvedby the FDA.

4.3.1.3 In advertising through mass media, approval num-ber must be present in such media and used during the approved period only.

4.3.1.4 No publicity or advertising of dangerous or speciallycontrolled drugs shall be performed in disguise through radio or televisionprogram or article in printed media.

4.3.1.5 Advertisement of pharmaceutical product for drug-store channel shall not use words or actions which may cause fears to the viewer,listener or reader in the manner that they are suffering from certain illness or aregoing to suffer from the illness if they are not treated.

4.3.1.6 Exaggerated claims to protect or treat serious ill-nesses without the need for doctor’s supervision are forbidden.

4.3.1.7 Advertisement of pharmaceutical product for drug-store channel making consumer adopt the presumption that they must rely on themedicine as solution is prohibited.

4.3.1.8 Advertisement of pharmaceutical product for drug-store channel with exaggerated claims other than the approved indication, in thesense that the product offers more than medical effects, is prohibited.

4.3.1.9 Pharmaceutical product for drugstore channel is notallowed to be advertised as a disguised tool in advertising dangerous or speciallycontrolled drugs, of which are legally prohibited from public advertising.

4.3.1.10 Pharmaceutical product for drugstore channel is notallowed to be advertised as a device to cause abortion or severe menstrualbleeding, sexual enhancement, contraceptive, promotion of sexual virility oreffective in treating sexual over-indulgence or any other ailment associated withthese habits.

4.3.1.11 The word “tonic’’ should clearly state purpose forwhich the tonic is to be used according to the indication approved in the drugregistration and should not claim nor imply the message that may cause misun-derstanding that it is an aphrodisiac or treats impotency or ageing.

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‡¢â“„®º‘¥«à“‡ªì𬓇 √‘¡ √â“ß ¡√√∂¿“æ∑“ß‡æ» À√◊Õ√—°…“ªí≠À“§«“¡ÕàÕπ·Õ∑“ß‡æ» À√◊Õ√—°…“§«“¡™√“¿“æ

4.3.1.12 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“„À⇰‘¥§«“¡À«—ßÀ√◊Õ§«“¡À≈ߺ‘¥«à“‡ªìπ¬“√—°…“À√◊Õ∫√√‡∑“§«“¡æ‘°“√∑“ß°“¬À√◊Õ∑“ß®‘쉥â ∑—È߇ªìπ°“√™—Ë«§√“«À√◊Õ∂“«√

4.3.1.13 Àâ“¡„™â§”μàÕ‰ªπ’È„π°“√‚¶…≥“‡¿ —™¿—≥±å√â“π§â“ ‰¥â·°àçª≈Õ¥¿—¬é 牡ࡒ§«“¡‡ ’ˬßé çª√“»®“°Õ—πμ√“¬é ç™–ß—¥é çª≈‘¥∑‘Èßé ·≈–§”Õ◊ËπÊ∑’Ë¡’§«“¡À¡“¬‚ÕâÕ«¥„π∑”πÕ߇¥’¬«°—π

4.3.1.14 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬°“√ÕÕ° ≈“°√“ß«—≈ ™‘ß‚™§ „Àâ‚∫π—  §ŸªÕß à«π≈¥¢Õß·∂¡ ·≈–¢âÕ‡ πÕÕ◊ËπμàÕºŸâ∫√‘‚¿§∑’ˇªìπ°“√ à߇ √‘¡„À⇰‘¥°“√„™â¬“‚¥¬‡°‘𧫓¡®”‡ªìπ

4.3.1.15 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬°“√„Àâ√⓬ ·≈–∑—∫∂¡‡¿ —™¿—≥±åÀ√◊Õ∫√‘…—∑§Ÿà·¢àߢ—π À“°®–¡’°“√‡ª√’¬∫‡∑’¬∫ √√æ§ÿ≥¬“°—∫‡¿ —™¿—≥±åÕ◊ËπμâÕ߇ªìπ¢âÕ¡Ÿ≈∑’ˇ∑’ˬß∏√√¡ ‡ªìπ —μ¬å®√‘ß ‡°’ˬ«¢âÕß‚¥¬μ√ß°—∫º≈°“√√—°…“ À√◊Õº≈ª√–‚¬™πå∑’ˇ¥àπ™—¥μàÕºŸâ∫√‘‚¿§

4.3.1.16 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬°“√Õâ“ßÕ‘ß∂÷ß°“√√—∫√ÕߢÕß·æ∑¬å À√◊Õ°“√¬°¬àÕß √√æ§ÿ≥‚¥¬∫ÿ§§≈Õ◊Ëπ‚¥¬‡©æ“–∫ÿ§§≈“°√∑“ß°“√·æ∑¬å ·≈– “∏“√≥ ÿ¢À√◊Õ‚¥¬°“√„™â∫ÿ§§≈·μàß°“¬· ¥ß‡ªìπ·æ∑¬å ∑—πμ·æ∑¬å ‡¿ —™°√ À√◊Õ欓∫“≈

4.3.1.17 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬„™â§≈‘π‘° À√◊Õ‚√ß欓∫“≈ ‡ªìπ©“°ª√–°Õ∫¿“悶…≥“

4.3.1.18 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬„™â¿“æÀ√◊Õ°“√· ¥ßÕ“°“√°‘𬓠À√◊Õ„™â¬“ ¬°‡«âπ·μà°√≥’∑’ËμâÕß°“√®–· ¥ß„À⺟â∫√‘‚¿§√Ÿâ«‘∏’°“√„™â¬“Õ¬à“ß∂Ÿ°μâÕ߇∑à“π—Èπ

4.3.1.19 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“„π≈—°…≥–™—°®Ÿß„À⇥Á°∫√‘‚¿§¬“‡Õß‚¥¬‰¡à¡’ºŸâª°§√Õß„Àâ°“√¥Ÿ·≈ ·≈–‰¡à‚¶…≥“‡¿ —™¿—≥±å√â“π§â“„π√“¬°“√À√◊Õ ◊ËÕ‚¶…≥“∑’Ë¡’‡¥Á°‡ªìπ°≈ÿࡇªÑ“À¡“¬‚¥¬μ√ß

4.3.1.20 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“„π≈—°…≥–∑’ËÕ“®°àÕ„À⇰‘¥§«“¡‡¢â“„®º‘¥μàÕª√‘¡“≥∫√√®ÿ ¢π“¥∫√√®ÿ ≈—°…≥–¬“ ¢âÕ∫àß„™â ·≈– √√æ§ÿ≥¢Õ߬“„π°“√√–ß—∫·≈–∫√√‡∑“Õ“°“√¢Õß‚√§„π∑—π∑’

4.3.1.21 °“√‚¶…≥“‡¿ —™¿—≥±å√â“π§â“§«√·π–π”ºŸâ∫√‘‚¿§„ÀâÕà“π·≈–ªØ‘∫—μ‘μ“¡‡Õ° “√°”°—∫‡ ¡Õ

4.3.1.22 Àâ“¡‚¶…≥“‡¿ —™¿—≥±å√â“π§â“‚¥¬°“√≈Õ°‡≈’¬π ‘Ëߪ√–¥‘…∞å

Code of sales PReMA 2010 11/30/10, 2:13 PM18

19PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

4.3.1.12 Pharmaceutical product for drugstore channel shallnot be advertised in misleading context to cure or treat physical or mental disor-der/disability both temporarily and permanently.

4.3.1.13 The following terms shall not be used in pharma-ceutical product for drugstore channel advertising: “safe”, “risk-free”, “instant”,“totally gone” and other terms in the similar exaggerated fashion.

4.3.1.14 It is not allowed that pharmaceutical product for drug-store advertisement to conduct prize-winning raffles, bonuses, discount coupons,giveaways and other propositions offered to the consumer with intention tostimulate excessive use of medicines.

4.3.1.15 Pharmaceutical product for drugstore channeladvertisement shall not be practiced in such a way that it contains malicious andderogatory reflections against competing products or companies. If comparisonsof drug indications with others are to be made, the information used must be fairand factual, directly related to treatment results or outstanding benefits to theconsumers.

4.3.1.16 Reference to physician endorsement or commenda-tion of its indications by others, especially by medical and health profession orany persons portraying physicians, dentists, pharmacists or nurse, are not al-lowed in advertisement of pharmaceutical product for drugstore channel.

4.3.1.17 The sights of a clinic or hospital as background forthe advertisement of pharmaceutical product for drugstore channel are not al-lowed.

4.3.1.18 Pharmaceutical product for drugstore channel adver-tisement shall not use pictures or demonstrations on drug consumption or druguse, unless otherwise with intention to demonstrate to consumers the proper useof medicines.

4.3.1.19 Pharmaceutical product for drugstore channel shallnot be advertised in any manner by which children may be tempted to consumewithout supervision of adults or on any program or advertising media for whichchildren are direct target group.

4.3.1.20 Pharmaceutical product for drugstore channel shallnot be advertised in any manner by which it may mislead that the medicines’contents, package size, appearance, and therapeutic use may provide immedi-ately relief of the disease or immediately reduce symptom.

4.3.1.21 Pharmaceutical product for drugstore channeladvertisement should always recommend consumers to read and follow directionaccording to product leaflet.

4.3.1.22 Pharmaceutical product for drugstore channel shall

Code of sales PReMA 2010 11/30/10, 2:13 PM19

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¢âÕ§«“¡ §”¢«—≠ √Ÿª¿“æ À√◊Õ√Ÿª·∫∫∑’Ë„™â‚¥¬∫√‘…—∑Õ◊Ëπ ´÷ËßÕ“®°àÕ„À⇰‘¥§«“¡‡¢â“„®º‘¥·≈– —∫ π‰¥â

4.3.1.23 ºŸâ‚¶…≥“‡¿ —™¿—≥±å√â“π§â“μâÕ߇¢â¡ß«¥°«¥¢—π ◊ËÕ‚¶…≥“¢Õßμπ‡æ◊ËÕ‡ªìπÀ≈—°ª√–°—π«à“°“√‚¶…≥“∑’Ë∑”¢÷Èπ‰¡à¡’¢âÕ§«“¡ ¿“æ ·≈–°“√· ¥ß°“√ ◊ËÕ§«“¡∑’Ë¢—¥μàÕ¢π∫∏√√¡‡π’¬¡ «—≤π∏√√¡ ·≈–»’≈∏√√¡Õ—π¥’ À√◊Õ°àÕ„À⇰‘¥§«“¡‡ ◊ËÕ¡‡ ’¬·Àà߇°’¬√μ‘·≈–»—°¥‘Ï»√’¢Õ߇™◊ÈÕ™“μ‘À√◊Õ‡æ»

4.3.2 °“√‚¶…≥“‚¥¬μ√ß∂÷ߺŸâ∫√‘‚¿§4.3.2.1 Àâ“¡‚¶…≥“‡æ◊ËÕ¢“¬‡¿ —™¿—≥±å√â“π§â“‚¥¬μ√ß∑“߉ª√…≥’¬åμàÕºŸâ

∫√‘‚¿§ ∑—Èßπ’ÈμâÕ߉¡à¢—¥°—∫°ÆÀ¡“¬«à“¥â«¬¬“ °ÆÀ¡“¬«à“¥â«¬°“√¢“¬·≈–°“√μ≈“¥·∫∫μ√ß4.3.2.2 °“√·®°®à“¬μ—«Õ¬à“߇¿ —™¿—≥±å∂÷ߺŸâ∫√‘‚¿§μâÕߪؑ∫—μ‘„Àâ∂Ÿ°μâÕß

μ“¡°Æ·≈–ª√–°“»¢Õß ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“4.3.2.3 °“√ à߇ √‘¡°“√¢“¬‚¥¬μ√ß∂÷ߺŸâ∫√‘‚¿§„π√â“π¢“¬¬“μâÕß°√–∑”

„Àâ∂Ÿ°μâÕßμ“¡À≈—°‡°≥±å∑’Ë√–∫ÿ‰«â„π¢âÕ 4.3.14.3.2.4 °‘®°√√¡ à߇ √‘¡°“√¢“¬∑’Ë°√–∑”‚¥¬μ√ß∂÷ߺŸâ∫√‘‚¿§ μâÕ߉¡à

‡ªìπ°“√∑”≈“¬¿“ææ®πå¢Õß√â“π¢“¬¬“ À√◊Õ𔧫“¡‡ ◊ËÕ¡‡ ’¬¡“ ŸàÕÿμ “À°√√¡¬“4.3.2.5 °“√‚¶…≥“‚¥¬μ√ß∂÷ߺŸâ∫√‘‚¿§„π√Ÿª·∫∫°“√ÕÕ°√â“π· ¥ß

º≈‘μ¿—≥±å Àâ“¡¡‘„Àâ¡’°“√¢“¬¬“ ·®°μ—«Õ¬à“ß ·≈–°“√∑¥≈Õß„™â„π√Ÿª·∫∫μà“ßÊ ¬°‡«âπ¬“∑’ˉ¥â√—∫Õπÿ≠“μμ“¡°ÆÀ¡“¬ ·≈–‰¡à„™à¬“§«∫§ÿ¡æ‘‡»…À√◊Õ¬“Õ—πμ√“¬

4.3.3 °“√ à߇ √‘¡°“√¢“¬‚¥¬μ√ß∂÷ߺŸâª√–°Õ∫°“√√â“π§â“4.3.3.1 °“√ à߇ √‘¡°“√¢“¬‡¿ —™¿—≥±å√â“π§â“∑’Ë°√–∑”‚¥¬μ√ßμàÕ√â“π§â“

„π∑ÿ°√Ÿª·∫∫ μâÕ߇ªìπ∏√√¡ ‡∑’ˬßμ√ß·≈–‡ªìπ —μ¬å®√‘ß ‰¡à«à“®–‡ªìπ°“√ ◊ËÕ„¥Ê À√◊ե⫬§”查¢âÕ§«“¡ ¿“æπ‘Ëß À√◊Õ¿“æ· ¥ßª√–°Õ∫‡ ’¬ß

4.3.3.2 °‘®°√√¡ à߇ √‘¡°“√¢“¬∂÷ߺŸâª√–°Õ∫°“√√â“π§â“ μâÕß∂Ÿ°°ÆÀ¡“¬‰¡à¢—¥μàÕ¢π∫∏√√¡‡π’¬¡·≈–»’≈∏√√¡Õ—π¥’ ·≈–‰¡à‡ªìπ°“√𔧫“¡‡ ◊ËÕ¡‡ ’¬ ŸàÕÿμ “À°√√¡¬“

4.3.3.2.1 «— ¥ÿ∑’Ë„™â à߇ √‘¡°“√¢“¬ ‡™àπ ¢Õß™”√૬ μâÕ߇ªìπ‰ªμ“¡¢âÕ°”Àπ¥¢Õß ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ·≈–¡Ÿ≈§à“‰¡à‡°‘π™‘Èπ≈– 500 ∫“∑

4.3.3.2.2 ¢Õß ¡π“§ÿ≥摇»…∑’Ë„Àâ°—∫ºŸâª√–°Õ∫°“√ ‰¡à§«√„Àâ¿“æ≈—°…≥å¢Õߧ«“¡øÿÉ¡‡øóÕ¬ √«¡∑—È߉¡à§«√‡ªìπº≈‘μ¿—≥±å∑’Ë¡’º≈‡ ’¬μàÕ ÿ¢¿“æ·≈–¢—¥°—∫»’≈∏√√¡Õ—π¥’ μ“¡‡ß◊ËÕπ‰¢∑“ß°“√§â“∑’Ë„À⺟âª√–°Õ∫°“√ ‡™à𠇧√◊ËÕߥ◊Ë¡∑’Ë¡’·Õ≈°ÕŒÕ≈å·≈–∫ÿÀ√’Ë ‡ªìπμâπ

4.3.3.2.3 °“√ÕÕ°√â“π· ¥ßº≈‘μ¿—≥±å ∂◊Õ‡ªìπß“π ”§—≠„π°“√‡º¬·æ√à«‘™“°“√§«“¡√Ÿâ ŸàºŸâª√–°Õ∫°“√√â“π§â“ §«√≈–‡«âπ °‘®°√√¡∑’ˇ°’ˬ«°—∫°“√æπ—π °“√„™â

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21PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

not be advertised by imitating invention, messages, slogans, pictures and pat-terns used by other companies, which may otherwise cause misunderstandingand confusion.

4.3.1.23 Advertisers of pharmaceutical product for drugstorechannels shall strictly ensure that their advertisement does not contain wording,image or demonstrations which may convey message against the good custom,culture and morale or cause disgrace to any race or gender.

4.3.2 Direct-to-consumer advertising4.3.2.1 Pharmaceutical product for drugstore channel shall

not be advertised for sale directly to the consumers via direct mail and have tocomply with drug legislation and direct sales and marketing legislation.

4.3.2.2 Distribution of sample of pharmaceutical product fordrugstore channel must be in compliant with the rules and notification of the FDA.

4.3.2.3 Promotion of pharmaceutical product for drugstorechannel directly to consumers in the drugstore must comply with the measuresas mentioned under 4.3.1.

4.3.2.4 Promotional activities directly to the consumers shallnot undermine the image of the drugstore or discredit the pharmaceutical industry.

4.3.2.5 Selling of medicines, giving of samples nor conduct-ing any format of testing are not allowed during the direct-to-consumer advertise-ment in the form of product display, except for those legally approved medicines.However, such medicines shall not be specially controlled or dangerous medi-cines.

4.3.3 Trade Promotion4.3.3.1 Trade promotion directly to drugstore operators must

be fair, accurate and truthful in all forms of communications or through verbalcommunication, wording, picture or soundtrack movie.

4.3.3.2 Trade promotion to drugstore operator shall abideby the laws and shall not be against the good customs and morale nor discreditthe pharmaceutical industry.

4.3.3.2.1 Promotional materials used, e.g., give-aways, shall comply with the FDA requirements and have value not exceed 500baht per piece.

4.3.3.2.2. Special gift shall not give the impressionof luxury, including not be harmful to health nor against good morale, based ontrade conditions with drugstore operators, such as alcohol and cigarettes, etc.

4.3.3.2.3 Product display in booth exhibition is con-sidered important task in disseminating technical knowledge to the drugstore

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‡ ’¬ßÕ÷°∑÷°§√÷°‚§√¡ °“√„™â· ß ‡ ’¬ß À√◊Õ°≈‘Ëπ ∑’Ë√∫°«πºŸâÕÕ°√â“π· ¥ßº≈‘μ¿—≥±å√“¬Õ◊ËπÀâ“¡®—¥„Àâ¡’‡§√◊ËÕߥ◊Ë¡·Õ≈°ÕŒÕ≈剫â„π∫√‘‡«≥√â“π∑’Ë· ¥ß‡¿ —™¿—≥±å

4.3.3.2.4 °“√ª√–™ÿ¡«‘™“°“√ ”À√—∫ºŸâª√–°Õ∫°“√ ‡π◊ÈÕÀ“¢Õß°“√ª√–™ÿ¡«‘™“°“√π—Èπ μ—ÕßÕ‘ß°—∫¢âÕ¡Ÿ≈„π·ßà«‘™“°“√ ·≈–μâÕß¡’‡Õ° “√Õâ“ßÕ‘ß„π‡«≈“∑’Ë¡’‡ª√’¬∫‡∑’¬∫ª√– ‘∑∏‘¿“æ°—∫º≈‘μ¿—≥±åμ—«Õ◊Ëπ

4.3.3.2.5 °“√ à߇ √‘¡°“√¢“¬√à«¡°—∫ºŸâª√–°Õ∫°“√ μâÕ߉¡à„™â°≈Õÿ∫“¬ ‡æ◊ËÕ™—°®ŸßÀ√◊Õ‚πâ¡πâ“«„À⺟â∫√‘‚¿§‡°‘¥°“√∫√‘‚¿§¬“‡°‘𧫓¡®”‡ªìπ À√◊Õμ◊Ëπμ√–Àπ°μàÕ ÿ¢¿“æÀ√◊Õ‚√§¿—¬‰¢â‡®Á∫Õ◊ËπÊ

4.3.3.3 ¢Õߢ«—≠‡≈–°“√√—∫√ÕߢÕߢ«—≠4.3.3.3.1 °“√„Àâ¢Õߢ«—≠μâÕ߉¡à¡’º≈‡ ’¬μàÕ ÿ¢¿“æ·≈–‰¡à¢—¥

μàÕ»’≈∏√√¡·≈–ª√–‡æ≥’Õ—π¥’¢Õß —ߧ¡4.3.3.3.2 °“√®à“¬‡ß‘πÀ√◊Õ¢Õߢ«—≠∑’Ë “¡“√∂μ’§à“‡ ¡Õ‡ß‘π ¥

(‡™à𠇙Á§¢Õߢ«—≠) „À⺟âª√–°Õ∫°“√√â“π§â“ ‡ªìπ‡√◊ËÕßμâÕßÀâ“¡4.3.3.3.3 ¢Õߢ«—≠∑’Ë¡Õ∫„Àⷰຟâª√–°Õ∫°“√√â“π§â“ „π‚Õ°“ 

ª√–‡æ≥’·≈–‡∑»°“≈∑âÕß∂‘Ëπ °√–∑”‰¥â„π≈—°…≥– 牡à∫àÕ¬§√—Èßé ‚¥¬¢Õߢ«—≠π—Èπ§«√¡’≈—°…≥–‡°’ˬ«¢âÕß°—∫ª√–‡æ≥’À√◊Õ‡∑»°“≈π—ÈπÊ ·≈–μâÕß¡’¡Ÿ≈§à“‰¡à‡°‘π 3,000 ∫“∑ μàÕ°“√„Àâ„π·μà≈–‚Õ°“ 

°“√√—∫√Õß4.3.3.3.4 °“√®—¥À√◊Õ®à“¬‡ß‘π ‡æ◊ËÕ®—¥°“√√—∫√Õß À√◊Õ °‘®°√√¡

π—π∑π“°“√ ®–μâÕ߉¡àøÿÉ¡‡øñÕ¬ ·≈–¢—¥μàÕ»’≈∏√√¡·≈–ª√–‡æ≥’Õ—π¥’¢Õß —ߧ¡ ∑—Èßπ’È °‘®°√√¡∑“ß —ߧ¡‡¥’ˬ« Ê (‰¡à‡ªìπ à«πÀπ÷Ëß„π°“√ π∑π“¢âÕ¡Ÿ≈∑“ß«‘™“°“√ À√◊Õ∏ÿ√°‘®) ‡ªìπ‡√◊ËÕßμâÕßÀâ“¡

4.3.4 °“√‡º¬·æ√à‚¶…≥“·≈–ª√–™“ —¡æ—π∏å4.3.4.1 °“√„Àâ¢à“«‚¥¬ ¡“™‘° À√◊Õμ—«·∑π¢Õß ¡“™‘° °“√·π–π”‡¿ —™-

¿—≥±å√â“π§â“„À¡à∑“ßÀπ—ß ◊Õæ‘¡æå À√◊Õ ◊ËÕ¡«≈™π„¥°Áμ“¡μâÕß°√–∑”„Àâ∂Ÿ°μâÕßμ“¡¡“μ√∞“π¬Õ¡√—∫‡ªì𧫓¡®√‘ß„π∑ÿ° √√æ§ÿ≥∑’ËÕÕ°¢à“« μâÕ߉¡à‡ªìπ°“√¥à«π √ÿª∑’ˇ≈Áߺ≈‡≈‘» „π∑ÿ°°√≥’°“√„Àâ¢à“«μâÕß°√–∑”„Àâ∂Ÿ°μâÕßμ“¡¢âÕ°”Àπ¥„πæ√–√“™∫—≠≠—쑬“∑’Ë¡’º≈∫—ߧ—∫„™â

4.3.4.2 °‘®°√√¡∑“ß°“√μ≈“¥Õ◊ËπÊ §«√ªØ‘∫—μ‘μ“¡√–‡∫’¬∫·≈–¢âÕ∫—ߧ—∫∑“ß°ÆÀ¡“¬·≈–Àâ“¡¡‘„Àâ¡’°“√‚¶…≥“‡º¬·æ√ଓ՗πμ√“¬ ¬“§«∫§ÿ¡æ‘‡»… ¬“‡ æμ‘¥„Àâ‚∑…·≈–«—μ∂ÿÕÕ°ƒ∑∏‘Ï ·Õ∫·Ωß„π°‘®°√√¡π—ÈπÊ

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23PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

operators. Therefore, it should refrain from activities related to gambling, use ofloud noise, light, sound or smell which may disturb other booth exhibitors. Noarrangement of alcoholic drinks allowed in the area of the booth exhibition.

4.3.3.2.4 Technical session in the symposium for thedrugstore operators shall refer to technical information and must have referencewhenever there is comparison of effectiveness with other products.

4.3.3.2.5 Trade promotion together with the drug-store operator shall not employ any tricks to entice or tempt the consumers tooveruse the medicine or to be panic about health or other illnesses.

4.3.3.3 Gift and HospitalityGift4.3.3.3.1 Gifts must not be products that cause

health problems or in conflict with good moral as judged by local standards.4.3.3.3.2 Payment in cash or cash equivalents (such

as gift certificate) must not be offered to drugstore operators.4.3.3.3.3 Gifts to drugstore operators for customary

and acceptable local occasions shall be allowed on an infrequent basis. The valueof such gifts, the nature and types of which are related to the particularly custom-ary occasions, shall not exceed Baht 3,000 per occasion.

Hospitality4.3.3.3.4 Hosting or paying for reception or recre-

ational activities shall not be luxurious nor against good moral or customs of thesociety. However, standalone social activity (as not part of discussion about sci-entific information or business) is prohibited.

4.3.4 Publicity and Public Relations4.3.4.1 News release by members or authorized represen-

tatives, introduction of a new product through print media, as well as any media,must be conducted in compliance with the standards. Such persons shall acceptthat every indication advertised is factual and shall not simply conclude that suchadvertised indication be the perfect answer. In all cases, all releases shall beconducted according to the requirement under provisions of the Drugs Act ineffect.

4.3.4.2 Other marketing activities are allowed, but must bepracticed according to regulation or legal requirement. There shall be no dis-guised advertisement of dangerous drug, specially controlled drugs, narcotics orpsychotropic substances in such events.

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4.4 ºŸâ·∑π‡«™¿—≥±å4.4.1 ºŸâ·∑π‡«™¿—≥±åμâÕ߉¥â√—∫°“√Ωñ°Õ∫√¡Õ¬à“߇撬ßæÕ ·≈–¡’«‘™“§«“¡√Ÿâ §«“¡

√—∫º‘¥™Õ∫‡æ’¬ßæÕ∑’Ë®–„Àâ¢âÕ¡Ÿ≈‡°’ˬ«°—∫‡¿ —™¿—≥±å‰¥âÕ¬à“ß∂Ÿ°μâÕß ·¡à𬔷≈–‡À¡“– ¡ „π°√≥’∑’˺Ÿâ·∑π‡«™¿—≥±å¡’§«“¡√Ÿâ‰¡à‡æ’¬ßæÕ„π°“√μÕ∫§”∂“¡ À√◊Õ¢âÕ ß —¬‡°’ˬ«°—∫‡¿ —™¿—≥±å„𧫓¡√—∫º‘¥™Õ∫¢Õßμπ ºŸâ·∑ππ—ÈπμâÕßμ‘¥μàÕ°—∫‡®â“Àπâ“∑’Ë ∑’Ë√—∫º‘¥™Õ∫‚¥¬μ√ߢÕß∫√‘…—∑·∑π°“√欓¬“¡μÕ∫ªí≠À“¥â«¬μπ‡Õß

4.4.2 ºŸâ·∑π‡«™¿—≥±åμâÕß¡’®√√¬“∫√√≥·≈–®√‘¬∏√√¡„π°“√ª√–°Õ∫Àπâ“∑’ˇ ¡Õ4.4.3 °“√‡ πÕ‡¿ —™¿—≥±å¥â«¬«“®“ ‡ªìπ≈“¬≈—°…≥åÕ—°…√ À√◊Õ¿“æπ‘Ëß À√◊Õ ‘Ëß

æ‘¡æåμâÕ߇∑’ˬßμ√ß ‡ªìπ∏√√¡ ·≈–¡’¡“μ√∞“π∑’ˬա√—∫‰¥â4.4.4 æ÷ßߥ‡«âπ°“√‡ª√’¬∫‡∑’¬∫∑’ˉ¡à‡ªìπ∏√√¡ À√◊Õ™’Èπ”„À⇢Ⓞ®º‘¥ À√◊Õ°“√

‡ª√’¬∫‡∑’¬∫∫àß∫Õ°¢âÕ¥’∑“ß √√æ§ÿ≥∑’ˉ¡à‡ªìπ®√‘ß4.4.5  ¡“™‘°®–μâÕß®—¥∑”√“¬≈–‡Õ’¬¥¢âÕ¡Ÿ≈∑“ß«‘™“°“√ ‡°’ˬ«°—∫‡¿ —™¿—≥±å∑’Ë

μâÕß°“√ à߇ √‘¡°“√¢“¬„Àâ°—∫ºŸâ·∑π‡«™¿—≥±å4.4.6 ºŸâ·∑π‡«™¿—≥±åμâÕß·μàß°“¬ ÿ¿“æ‡√’¬∫√âÕ¬À√◊Õ‡§√◊ËÕß·∫∫∫√‘…—∑¢≥–

ªØ‘∫—μ‘Àπâ“∑’Ë4.4.7 ‡¡◊ËÕ‰¥â√—∫¢âÕ¡Ÿ≈‡°’ˬ«°—∫Õ—πμ√“¬®“°°“√„™â‡¿ —™¿—≥±å ºŸâ·∑π‡«™¿—≥±å

§«√√“¬ß“π„Àâ°—∫‡®â“Àπâ“∑’˺Ÿâ√—∫º‘¥™Õ∫¢Õß∫√‘…—∑‡æ◊ËÕ¥”‡π‘π°“√μ“¡¢—ÈπμÕπμàÕ‰ª4.5.  ∂“π∑’Ë·≈–°“√®—¥®”Àπà“¬

4.5.1  ¡“™‘°§«√°√–®“¬°“√®”Àπà“¬‡¿ —™¿—≥±å√â“π§â“„Àâ¡’¢“¬∑—Ë«ª√–‡∑»‡æ◊ËÕ„Àâ∫√‘°“√ºŸâ∫√‘‚¿§‰¥â∑—Ë«∂÷ß

4.5.2 ºŸâº≈‘μ·≈–ºŸâ®—¥®”Àπà“¬μâÕß·π–π”√â“π§â“„À⇰Á∫«“ß ‘π§â“„Àâ‡À¡“– ¡·≈–∂Ÿ°«‘∏’ ‚¥¬∑’ˇ¿ —™¿—≥±å‡À≈à“π—ÈπμâÕ߉¡à‡ªìπ¬“∑’ËÀ¡¥Õ“¬ÿ

4.5.3 ºŸâº≈‘μ·≈–ºŸâ®—¥®”Àπà“¬§«√·π–π”„Àâ√â“π§â“ ”√Õß ‘π§â“„Àâ‡æ’¬ßæÕ·°à§«“¡μâÕß°“√¢ÕߺŸâ∫√‘‚¿§

5. °“√∫√‘À“√5.1 ¢âÕ√âÕ߇√’¬π‡°’ˬ«°—∫°“√≈–‡¡‘¥À≈—°‡°≥±åπ’È ∫√‘À“√®—¥°“√‚¥¬ ª√–∏“π

‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡·≈–§≥–°√√¡°“√«à“¥â«¬°“√æ‘®“√≥“„À⧫“¡‡ÀÁπ‡°’Ë¬«°—∫°“√°√–∑”º‘¥À≈—°‡°≥±å∑“ß°“√¢“¬·≈–°“√μ≈“¥ (‡√’¬°‚¥¬¬àÕ«à“ ç§æºμ.é)

5.2 ¢âÕ°”Àπ¥„πÀ≈—°‡°≥±åπ’È®–‰¥â√—∫°“√æ‘®“√≥“∑∫∑«π‚¥¬§≥–Õπÿ°√√¡°“√®√√¬“∫√√≥¥â“π°“√¢“¬·≈–°“√μ≈“¥ À≈—ß®“°√—∫øíߢâÕ§‘¥‡ÀÁπ®“°ΩÉ“¬∑’ˇ°’ˬ«¢âÕß¿“¬„π‡«≈“‰¡à‡°‘π∑ÿ° “¡ªï πÕ°‡Àπ◊Õ®“°°“√æ‘®“√≥“∑∫∑«πÀ≈—°‡°≥±åÕ¬à“ß ¡Ë”‡ ¡Õ·≈â« §≥–

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25PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

4.4 Sales Representatives4.4.1 Sales representatives shall be given adequate training to be

able to correctly, accurately and appropriately provide information about the phar-maceutical products. In the case where that sales representative does not havesufficient knowledge to answer question or entertain any queries about theproduct under his or her responsibility, he or she shall be obliged to contact thecompany’s official directly in charge of the product instead of trying to answer thequestion on one’s own.

4.4.2 Sales representatives shall at all times maintain a high stan-dard of ethical conduct in the discharge of their duties.

4.4.3 Presentation of pharmaceutical products, either verbally, inwriting, or as picture or in print, shall always be accurate, fair and with acceptablestandards.

4.4.4 Refrain from conducting comparison that is unfair or mislead-ing or showing untrue indication.

4.4.5 Members shall prepare summary of technical information per-taining to the product, of which it is to be promoted, to the sales representative.

4.4.6 Sales representatives shall dress professionally in businessattire or uniform while performing their duties.

4.4.7 When informed about the hazardous result from the pharma-ceutical products, sales representatives shall report to the person responsible ofthe company for further actions.

4.5. Place and Distribution4.5.1 Members should distribute pharmaceutical product for drug-

store channel throughout the country in order that the consumers can get accessof the products.

4.4.2 Manufacturers and distributors shall recommend the outletsto properly and correctly store the products and that the products shall have suf-ficient shelf life.

4.4.3 Manufacturers and distributors should recommend the drug-stores to adequately stock the products in order to meet consumers’ needs.

5. ADMINISTRATION5.1 Complaints regarding breaches of The Code will be administered by

the PReMA Chief Executive Officer and the Code of Conduct Committee (herein-after called as “CCC”).

5.2 Sales & Marketing Ethics Subcommittee (hereinafter referred to as‘the SME’) will carry out a review of the provisions of the Code after seeking inputfrom interested parties no later than every three years. Besides regular review of

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Õπÿ°√√¡°“√™ÿ¥π’È®–¥”‡π‘π°‘®°√√¡ √â“ߧ«“¡μ√–Àπ—°„πÀ≈—°‡°≥±å¥â«¬‡™àπ°—π5.3 ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡®–√—∫√Õß ·≈– àßμàÕ ¢âÕ√âÕ߇√’¬π¡“¬—ߧ≥–

°√√¡°“√ §æºμ.5.4 ∫∑∫“∑¢Õߧ≥–°√√¡°“√ §æºμ. §◊Õ °“√ª√–™ÿ¡√à«¡°—π‰μ√¡“ ≈–§√—È߇æ◊ËÕ

æ‘®“√≥“¢âÕ√âÕ߇√’¬π ·≈–∑”Àπâ“∑’ˇªìπºŸâæ‘æ“°…“ ≈Ÿ°¢ÿπ ·≈–ºŸâ —°§â“π®“°À≈—°∞“π∑’ˉ¥â√—∫ ·≈–μ—¥ ‘π„®¡“μ√°“√·∑√°·´ßμ“¡¡“μ√“ 7

6. °“√ªØ‘∫—μ‘μàÕ¢âÕ√âÕ߇√’¬πªí≠À“¢âÕ√âÕ߇√’¬π§«√μ°≈ß°—π‚¥¬μ√ß√–À«à“ß∫√‘…—∑∑’ˇ°’ˬ«¢âÕß „π√–¥—∫ºŸâ®—¥°“√

„À≠àÀ√◊Õª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√ ‡ªìπ‡∫◊ÈÕßμâπ°√–∫«π°“√¬◊Ëπ¢âÕ√âÕ߇√’¬π‡ªìπ∑“ß°“√ºà“π ¡“§¡¡’¥—ßπ’È6.1 °“√¬◊Ëπ¢âÕ√âÕ߇√’¬π - ¢âÕ√âÕ߇√’¬π®–μâÕß®—¥∑”‡ªìπ≈“¬≈—°…≥åÕ—°…√·≈–¬◊Ëπμ√ß

μàÕª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ¢âÕ√âÕ߇√’¬πÕ“®¡“®“° ¡“™‘°À√◊Õ®“°·À≈àßÕ◊Ëπ∑’ˉ¡à„™à ¡“™‘° ‡™àπ  ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ∫ÿ§≈“°√∑“ß°“√·æ∑¬å  ¡“§¡ºŸâª√–°Õ∫°“√√â“π§â“ ºŸâªÉ«¬À√◊Õ°≈ÿࡺŸâªÉ«¬

6.2 °“√√—∫√ÕߢâÕ√âÕ߇√’¬π - ¢âÕ√âÕ߇√’¬π∑’ˬ◊ËπμàÕ ¡“§¡®–μâÕ߉¥â√—∫°“√√—∫√Õß‚¥¬ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ‡æ◊ËÕ„À⇪ìπ‰ªμ“¡‡°≥±å°”Àπ¥¥—ßπ’È

6.2.1 ‡ªìπ‡√◊ËÕß∑’ˇ°‘¥®√‘ß ¬◊Ëπ‚¥¬∫√‘ ÿ∑∏‘Ï„®6.2.2 ¡’À≈—°∞“πæÕ∑’Ë®–¥”‡π‘π°“√μàÕ¢âÕ√âÕ߇√’¬πμàÕ‰ª‰¥â6.2.3 °√≥’∑’ˬ°¡“μâÕ߉¡à„™à‡√◊ËÕ߇°à“∑’ˇ§¬¡’°“√æ‘®“√≥“¬ÿμ‘¡“·≈â«μ“¡À≈—°‡°≥±åπ’È6.2.4 ¢âÕ¡Ÿ≈∑’ËμâÕ߬◊Ëπª√–°Õ∫¥â«¬

❒ ∑’Ë¡“¢ÕߢâÕ√âÕ߇√’¬π▲ ∂ⓧ”√âÕ߇√’¬π¡“®“°∫√‘…—∑À√◊ÕÕߧå°√ ®–μâÕß®—¥æ‘¡æå∫π

°√–¥“…À—«®¥À¡“¬¢Õß∫√‘…—∑À√◊Õߧå°√π—Èπ Ê ·≈–≈ßπ“¡‚¥¬ºŸâ®—¥°“√„À≠àÀ√◊Õª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√ °√≥’∑’ˇªìπ¢âÕ√âÕ߇√’¬π®“°∫ÿ§§≈∏√√¡¥“ μâÕß„Àâ™◊ËÕ °ÿ≈®√‘ß ∑’ËÕ¬Ÿà ·≈–À¡“¬‡≈¢‚∑√»—æ∑åμ‘¥μàÕ

❒  ¡“™‘°∑’Ë∂Ÿ°√âÕ߇√’¬π▲ „π·μà≈–°√≥’ ®–μâÕß√–∫ÿ™◊ËÕ¢ÕߺŸâ∑’Ë∂Ÿ°√âÕ߇√’¬π«à“≈–‡¡‘¥À≈—°‡°≥±å

·≈–™◊ËÕº≈‘μ¿—≥±å À√◊Õ°‘®°√√¡°“√μ≈“¥∑’ˇ°’ˬ«¢âÕß❒ À≈—°∞“πÕâ“ßÕ‘ß

▲ „π·μà≈–°√≥’ ®–μâÕß®—¥À≈—°∞“π∑’ˇªìπ‡Õ° “√Õâ“ßÕ‘ß√–∫ÿ°“√‚¶…≥“ À√◊Õ°‘®°√√¡ À√◊Õ ‘Ëßæ‘¡æå À√◊ÕÀ≈—°∞“πÕ◊ËπÊ ∑’ˇªìπ‡Àμÿ„Àâ¡’°“√√âÕ߇√’¬π

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27PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

the Code, the SME will also perform activities to create awareness of the Code.5.3 All valid complaints will be forwarded by the PReMA CEO to the

Code of Conduct Committee (CCC).5.4 The role of the CCC will be to meet on a quarterly basis to hear valid

complaints and act as judge, jury and cross examiner of the evidence beforethem and to ultimately decide on any sanction as per section 7.

6. COMPLAINTS PROCEDUREPreliminary all attempts shall be made to settle a dispute through direct

communication between the companies involved, at the General Manager (GM)or Chief Executive Officer (CEO) level.

The procedures for filing formal complaints via PReMA are as follows:6.1 Complaint Submission - All complaints must be submitted in writ-

ing directly to the PReMA CEO. Complaints can be made by either members orfrom non-member sources, e.g. Thai FDA, healthcare professionals or drugstoreoperatorsí associations, patients or patient groups.

6.2 Complaint Validation - Any complaints submitted to PReMA shallbe validated by the PReMA CEO to ensure that:

6.2.1 It appears to be a genuine matter, submitted in good faith.6.2.2 There is sufficient evidence to enable the complaint to be

processed.6.2.3 It is not a duplication of a case, which has already been

resolved under the Code.6.2.4 Minimum information required is;

❒ Source of the complaint▲ If the complaint is from a company or organization, it

must be printed on the company’s or organizationís letter head and signed off bythe GM or CEO. For complaint from an individual, real name, address andcontact telephone number must be provided.

❒ Alleged Member▲ For each case in the complaint, the identity of mem-

ber which is alleged to be in breach of the Code and the name of any product(s)/marketing activities must be specified.

❒ Reference material▲ For each case, a specific reference to the source of

the advertisement/activity or printed material which is the subject of the complaintas well as any other evidence must be provided.

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❒ «—π∑’Ë▲ «—π∑’Ë¡’°“√≈–‡¡‘¥À≈—°‡°≥±å

❒  √ÿª▲  ”À√—∫·μà≈–°√≥’ ∂Ⓡªìπ‰ª‰¥â„Àâ¡’°“√∫√√¬“¬ √ÿª¢âÕ√âÕ߇√’¬π ‚¥¬

Õâ“ß∂÷ßÀ≈—°‡°≥±å à«π∑’ˇ°’ˬ«¢âÕß (√–∫ÿμÕπ·≈–¬àÕÀπâ“)6.3 °“√¥”‡π‘π°“√μàÕ¢âÕ√âÕ߇√’¬π - ‡¡◊ËÕª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡‰¥â

√—∫¢âÕ√âÕ߇√’¬π‡ªìπ≈“¬≈—°…≥åÕ—°…√μ“¡¢âÕ 6.2 ·≈–‡ÀÁπ«à“ºŸâ∑’Ë∂Ÿ°√âÕ߇√’¬πÕ“®≈–‡¡‘¥À≈—°‡°≥±å®√‘ß °Á®–√—∫‡√◊ËÕ߉«âæ‘®“√≥“¥”‡π‘π°“√μ“¡À≈—°‡°≥±å ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡Õ“®¢Õ¢âÕ¡Ÿ≈À√◊ÕÀ≈—°∞“π‡æ‘Ë¡‡μ‘¡®“°ºŸâ√âÕßÀ√◊Õ®“°ºŸâ∑’Ë∂Ÿ°√âÕ߇√’¬π °àÕπ à߇√◊ËÕßæ√âÕ¡À≈—°∞“πμàÕ‰ª¬—ߧ≥–°√√¡°“√ §æºμ. ∑—Èßπ’È ¢âÕ¡Ÿ≈∑’ˇªìπ™◊ËÕºŸâ√âÕ߇√’¬π ºŸâ∑’Ë∂Ÿ°√âÕ߇√’¬π·≈–ºŸâ∑’ˇ°’ˬ«¢âÕß®–§ß‡°Á∫√—°…“‰«â‡ªì𧫓¡≈—∫°àÕ𠇫âπ‡ ’¬·μà«à“‰¡àÕ“®æ‘®“√≥“§¥’‰¥â‚¥¬‰¡à¡’°“√‡ªî¥‡º¬™◊ËÕº≈‘μ¿—≥±å °‘®°√√¡ À√◊Õ  ∂“π∑’ˇ°‘¥‡Àμÿ

6.4 °“√æ‘®“√≥“§¥’ - §≥–°√√¡°“√ §æºμ. ®–æ‘®“√≥“°√≥’√âÕ߇√’¬π À“°®”‡ªìπμâÕߢբâÕ¡Ÿ≈À√◊ÕÀ≈—°∞“π‡æ‘Ë¡‡μ‘¡ °Á®–·®â߉ª¬—ߺŸâ√âÕß·≈–ºŸâ∑’Ë∂Ÿ°√âÕ߇√’¬π ºà“πª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ®“°π—Èπ§≥–°√√¡°“√ §æºμ. ®–æ‘®“√≥“«à“¡’°“√≈–‡¡‘¥À≈—°‡°≥±åÀ√◊Õ‰¡à®“°À≈—°∞“π∑’Ë√«∫√«¡‰¥â

6.5 °“√μ—¥ ‘π - ¡μ‘¢Õߧ≥–°√√¡°“√ §æºμ. ®–√“¬ß“πμ√߉ª¬—ߪ√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ´÷Ëß®–‡ªìπºŸâ·®âß„Àâ°—∫ºŸâ∑’Ë∂Ÿ°√âÕ߇√’¬π·≈–ºŸâ√âÕ߇√’¬π∑√“∫ °“√·∑√°·´ß∑’Ë≈–‡¡‘¥À≈—°‡°≥±å®–¥”‡π‘π°“√‚¥¬ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ‚¥¬„À⇪ìπ‰ªμ“¡¢âÕ 7 ¢ÕßÀ≈—°‡°≥±åπ’È

6.6 °“√æ‘®“√≥“„À¡à - À“°ºŸâ∂Ÿ°√âÕ߇√’¬πÀ√◊ÕºŸâ√âÕ߇√’¬π‰¡à‡ÀÁπ¥â«¬°—∫º≈°“√æ‘®“√≥“¢Õߧ≥–°√√¡°“√ §æºμ. °ÁÕ“®¬◊Ëπ¢Õ„Àâ¡’°“√æ‘®“√≥“„À¡à ‚¥¬®–μâÕß∑”‡ªìπ≈“¬≈—°…≥åÕ—°…√æ√âÕ¡À≈—°∞“π‡æ‘Ë¡‡μ‘¡„À¡à¿“¬„π‡«≈“ 10 «—πÀ≈—߉¥â√—∫·®âߺ≈°“√æ‘®“√≥“®“°ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ °√≥’¡’°“√¬◊ËπÀ≈—°∞“πÀ√◊Õ¢âÕ‚μâ·¬âß„À¡à®–μâÕ߇ªìπÀ≈—°∞“π´÷Ëß¡‘‡§¬¬°¢÷ÈπøÑÕß√âÕß¡“°àÕπ·≈–‡ªìπ “√– ”§—≠∑’Ë®–π”„Àâº≈°“√æ‘®“√≥“‡ª≈’ˬπ·ª≈߉¥â ®–¡’°“√‡™‘≠Õ’°ΩÉ“¬¡“™’È·®ß¢âÕ‡∑Á®®√‘ß¿“¬„π 30 «—𠧔엥 ‘π¢Õߧ≥–°√√¡°“√§æºμ. „π™—Èππ’È∂◊Õ‡ªìπ∑’Ë ÿ¥·≈–¡’º≈∫—ߧ—∫

6.7 ª√–∏“π‡®â“Àπâ“∑’Ë∫√‘À“√¢Õß ¡“§¡ ®–∑”Àπâ“∑’Ë√“¬ß“π¢âÕ√âÕ߇√’¬π∑’ˉ¥â√—∫∑—ÈßÀ¡¥ º≈°“√æ‘®“√≥“§¥’¢Õߧ≥–°√√¡°“√ §æºμ. ·≈–°“√¥”‡π‘π°“√μ“¡§”μ—¥ ‘π μàÕ ¡“™‘° ¡“§¡ ™◊ËÕ¢ÕߺŸâ√âÕ߇√’¬π®–¬—ߧ߇°Á∫√—°…“‰«â‡ªì𧫓¡≈—∫ ·μà®–‡ªî¥‡º¬™◊ËÕ¢Õß∫√‘…—∑∑’Ë≈–‡¡‘¥À≈—°‡°≥±å

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29PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

❒ Date▲ The date of the alleged breach of the Code

❒ Summary▲ If possible for each case, a brief description of the com-

plaint with a specific reference to the part of the Code under which the complaintis being made (section & paragraph)

6.3 Complaint Processing - When the PReMA CEO receives a signedcomplaint validated in accordance with section 6.2, and it appears that the al-leged member may have contravened the Code, the case will be accepted foradjudication. The PReMA CEO may request for additional information or evi-dence from the complainant or the alleged member. The case with all evidencewill then be forwarded to the CCC. The names of the complainant, the allegedmember in breach and any healthcare professionals involved, will remain confi-dential, EXCEPT when it is not possible to adjudicate the case without the nameof the product, activity or venue involved being disclosed.

6.4 Complaint Adjudication - The CCC shall review the case. If thereis a need for additional information or evidence, a request will be made to thecomplainant and alleged member via the PReMA CEO. The CCC will then adju-dicate whether a breach of the Code has occurred based on the compiled evi-dence.

6.5 Disposal - The decision of the CCC will be reported directly to thePReMA CEO, who will inform both the alleged member and the complainant ofthe decision. Sanction against the member found in contravention of the Codewill be applied by the PReMA CEO, subject to Section 7 of the Code.

6.6 Complaint Resubmission - Where the alleged member or com-plainant disagrees with the decision of the CCC they may request a second in-stance ruling. The resubmission must be made in writing with any new evidence,of which never been raised before and would be substantial towards the changeof the decision, within 10 days after receiving the notification from the PReMACEO. If new evidence or arguments are put forward, the other party shall beinvited to provide comments within 30 days. The decision of CCC at this stage willbe regarded as final and executory.

6.7 The PReMA CEO shall report all valid complaints received, the CCCadjudications and the actions taken to the members. The name of the complain-ants will remain confidential but the names of the breaching companies will bedisclosed.

Code of sales PReMA 2010 11/30/10, 2:13 PM29

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Code of sales PReMA 2010 11/30/10, 2:13 PM30

31PReMA CODE OF SALES & MARKETING PRACTICES 3rd EDITION, 2011

7. SANCTIONSThe PReMA CEO, upon the decision of the CCC, shall apply one or more

of the following sanctions to the member found in breach of the Code:-7.1 Refer the complaint to the International Federation of Pharmaceuti-

cal Manufacturers’ Association (IFPMA).7.2 Refer the complaint and the Committeeís finding to the head office

and regional office of the offending company.7.3 Suspend the offending companyís membership for not more than

3 years.7.4 Debar the offending company from membership of the Association,

under Section 12.7 (2) of the PReMA Articles of Association.7.5 A written undertaking that the practice complained of, will be discon-

tinued on or before a date to be determined by the CCC.7.6 Retraction statements, including corrective letters and advertising,

to be issued by the Subject Company, subject to the approval of the CCC prior torelease. It is the company’s responsibility to ensure that the requirements of theCCC are met and to immediately inform and provide evidence to PReMA of theirfulfillment.

7.7 The issuing of a fine by PReMA to the Subject Company as perfollows:

7.7.1 A fine not exceeding the value of 100,000 Baht, for a firstoffence.

7.7.2 A fine not exceeding the value of 500,000 Baht for a secondoffence, within a 12 month period.

7.7.3 The fine to be paid within 30 days of being advised, subject toany appeal that may be lodged under Section 6.6 of the Code.

8. OPREATIVE DATE8.1 The Third Edition of the Code of Sales and Marketing Practices for

Drugstore, Drugstore Operator and Drugstore Operator Who Sells Pharmaceuti-cal Products shall take effect on the 1 January 2011 onwards and it shall replacethe previous OTC Code of Marketing Practices, 2nd Edition, of the Association.

8.2 In case that this Code has not set specific practice guideline oroperation procedure, the regulation of the Code of Conduct Committee B.E.2552 (2009) shall be applied mutatis mutandis.9. PReMA CEO shall be in charge of this Code.

Announced on the date 1 January 2011

Code of sales PReMA 2010 11/30/10, 2:13 PM31

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408/85 Õ“§“√æÀ≈‚¬∏‘π‡æ≈  ™—Èπ 19∂ππæÀ≈‚¬∏‘π  “¡‡ π„π æ≠“‰∑ °√ÿ߇∑æœ 10400‚∑√. 0-2619-0232-6 ‚∑√ “√ 0-2619-0237408/85, 19th Fl., Phaholyothin Place Bldg.,Phaholyothin Road, Samsennai, Phayathai, Bangkok 10400, ThailandTel. : 0-2619-0232-6 Fax : 0-2619-0237www.prema.or.th E-mail : [email protected]

Code of sales PReMA 2010 11/30/10, 2:13 PM32