GENERAL PROVISION APPLICABLE TO ALL SALES & MARKETING PRACTICES

3.1

Marketing Practices should never be such as to bring discredit upon the pharmaceutical industry. Marketing practices utilized should be able to withstand public scrutiny

3.2 Information of the product (or sometimes referred to as “product information”) furnished to the healthcare profession about the product should be current, accurate, balanced, and should not be misleading either directly, by implication, by omission or addition. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers.

3.3 In quoting from medical literature, or from the communications of clinical investigators, special care should be taken to ensure that the meaning of the original, taken as a whole, is not distorted.

3.4 Disparaging references to other products or manufacturers should be avoided.

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, 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. The word ‘Safe’ must not be used in promotion, without qualification (i.e. it should be ‘safe’ relating to ...+ reference).

3.6 Particular care should be taken that essential information on any pharmaceutical products’ safety, contra-indications, side effects or toxic hazards is properly communicated to the Thai regulatory authorities and to healthcare profession of Thailand.

To comply with the above, in all printed promotional materials (with the exception of reminder (short) advertisements, as mentioned under 3.9), the following list of information should be printed:

the name(s) of the active ingredient(s) using either international nonproprietary 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 or distributor;

reference to 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. The promotional material shall only be used only during the validity period of the approval.

3.7 When certified package inserts are required by the Thai FDA to be printed and provided in the Thai and English languages, the information imparted in both languages should be the same unless the text is changed by the FDA.

3.8 Any and all information required by the Thai FDA to be printed on the carton or label should be clearly legible.

3.9 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 information available on request’, the company logo and local address.

3.10 All members should have an established procedure for reporting ADR’s and product recall. All medical representatives and other appropriate staff should be made fully aware of the company’s internal policies and procedures.

3.11 All member companies will assume responsibility, under the Code, for correcting breaches of the Code resulting from misconduct or misrepresentation of facts by any representative.

 

 
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