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					GUIDELINES ON MEDICAL PRODUCTS AND APPLIANCES 1. Introduction 1.1 This guideline is intended to complement the provisions of the Medicines (Advertisement & Sale) Act 1956 (Revised – 1983) and the Medicine Advertisement Board Regulation 1976. 1.2 Advertisements include any notice, circular, report, commentary, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound. 2. Objectives 2.1 The objective of this guideline is to ensure responsible advertising in promoting the sale of medicines, appliances or remedies which may be purchased by the public without prescription and for which medical claims are made. 2.2 Advertisements to the general public should: (a) Help people to make rational decisions on the use of medicines, appliances, remedies determined to be legally available without a prescription; (b) Take into account of people‟s legitimate desire for information regarding their health. (c) Not take undue advantage of people‟s concern for their health.

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3. Authority 3.1 The Medicine Advertisements Board (MAB) may, at its discretion, issue or refuse to issue any approvals for advertisements to be publicized or may cancel any approvals which were previously issued. 3.2 The Medicine Advertisements Board reserves the right to delete from any advertisements, acts which could bring about undesirable thoughts and impression to the viewers. 3.3 Changes to the Guidelines may be made from time to time by the Medicine Advertisements Board without giving prior notice. 4. Prohibitions 4.1 Advertisements should not refer to any article or articles in terms which are calculated to lead to the use of that article or articles for the purpose of:(a) Prevention, diagnosis or treatment of the diseases and condition of human beings as specified in the Schedule to The Medicines (Advertisement & Sale) Act 1956 (Revised – 1983) ; The list is reproduced as follows:1. Diseases or defects of the kidney 2. Diseases or defects of the heart 3. Diabetes 4. Epilepsy or fits 5. Paralysis 6. Tuberculosis 7. Asthma 8. Leprosy 9. Cancer 10. Deafness
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11. Drug addiction 12. Hernia or rupture 13. Diseases of the eye 14. Hypertension 15. Mental 16. Infertility 17. Frigidity 18. Impairment of the sexual function or impotency 19. Venereal disease 20. Nervous debility, or other complaint or infirmity, arising from or relating to sexual intercourse. b) c) Practicing contraception among human beings: Improving the condition or functioning of the human kidney or heart, or improving the sexual function or sexual performance of human beings: d) 4.2 Procuring the miscarriage of women.

No products which are poisons or contain poisons as specified in the Poisons list set out in the First Schedule to the Poisons Act 1952 (Revised 1989) may be advertised.

5. Contents of Advertisement Advertisements should contain information that is reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain any misleading or unverifiable or omissions likely to induce medically unjustifiable use or to give rise to undue risks.

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5.1 General Principles 5.1.1. Impressions of Professional Advice or Endorsement Advertisements should not:(a) have any visual and/or audio presentation of doctors, dentists pharmacists, scientists, nurses and other paramedics, etc., which give the impression of professional or scientific advice, recommendation or endorsement: (b) contain statements giving the impression of professional of scientific advice, endorsement or recommendation made by associations or persons who appear in the advertisements and who are presented either directly or by implication, as being qualified to give such advice, endorsement or recommendation. 5.1.2. Standard of Morality or Decency. Advertisements should not contain statements or visual presentation which is, or likely to be interpreted to be contrary or offensive to the standard of morality or decency prevailing in the Malaysian society or in any way defamatory or humiliating to any segment of the public. 5.1.3. Trust, Fear or Superstition Advertisements should not:(a) be so framed as to abuse the trust of the consumer or exploit his lack of experience or knowledge. (b) without justification play on fear. Advertisements should not contain any statement or illustration likely to induce fear on the part of the viewer or listener that he is suffering, or may without
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diagnosis or treatment suffer, or suffer more severely, form diseases or conditions of the human body. (c) play on superstition or exploit the superstitious. In this spirit, words like magic, magic, miracle, miraculous, saintly heavenly, or presentation of or reference to mythical object or supernatural beings or powers should no t be allowed. (d) directly or by implication exploit the religious requirement/beliefs of any community. 5.1.4. Acts of Violence or Illegal Activities Advertisements should not contain anything, which might lead or lend support to acts of violence, or criminal or illegal activity nor should they appear to condone such acts or activities. 5.1.5. Dangerous Practices or Disregard for Safety Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. Special care should be taken in advertisements directed towards or depicting children or young people. 5.1.6. Disparagement (Discredit) Advertisement should not: (a) contain any statement which either expressly or by implication disparages either the medical profession or the value of professional attention and treatment or another product.

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(b)

Discredit or unfairly attack other products, advertisers or advertisements directly or by implications.

5.1.7. Children or Young People Advertisements addressed to children or young people, or likely to be seen by them, should not contain anything, whether in illustration or otherwise, which might result in harming them physically, mentally, or morally, or which exploits their credulity, their lack of experience or their natural sense of loyalty. 5.2. Misleading Statement Advertisements should not contain any statement, or visual presentation which, directly or by implication, omission, ambiguity or claim, is likely to mislead the consumer about any product or advertiser, in particular with regards to: (a) (b) The trade description; Official or other recognition of approval or certification.

5.3. Substantiation All descriptions, claims and comparisons which relate to matters of objectively ascertainable facts should be capable of substantiation and should be held ready for immediate production upon request to the Medicine Advertisements Board 5.4. Tests, Trials, Research Reference expressly or by implication to test, trials, research and the like may only be used if they are fully substantiated. References to tests or trials conducted in a named hospital, clinic, institute, laboratory or college or by
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named professional or official organization is permissible only if authorized and approved by the authority of the institution or organization concerned and found acceptable by the Medicine Advertisements Board. 5.4.1. Advertisements should not: (a) contain any medical statement or reference to clinical or other trials or tests which cannot be substantiated by authoritative evidence acceptable by the Medicine Advertisements Board. (b) misuse research results or quotation from technical and scientific literature or conference, workshop, seminar etc. Statistics should not be so presented as to imply that they have a greater validity than is the case. Scientific terms or scientific jargons that are irrelevant should not be used to make claims that appear to have a scientific basis that they do not possess. 5.5. Testimonials “No advertisement for a product may include a testimonial:” (a) (b) by a professional or scientific association, body or organization. by a person well-known in public life, sport, entertainment, professional or scientific bodies, associations, organizations etc. 5.6. Name of Product or Brand Name (a) Advertisement of a product with a name containing the term “Doctor” or “Dr.” is not acceptable unless the product was marketed under the name prior to 1st. July, 1977.

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(b)

The name of a product should not indicate or imply its effectiveness or superior quality.

(c)

Advertisement of a product should not highlight the name of manufacturer or foreign country of origin.

5.7. General Claims 5.7.1. Hyperbole Hyperbole should not be used in Medicine Advertisements unless such hyperbole is used to attract attention to the advertisement and is not used or implied in the advertisement as a claim or inference to the superiority or superlative status of the product advertised. Advertisements should not: (a) contain a copy which is exaggerated by reason of the improper use of words, phrases or methods of presentation e.g. the use of the words Fabulous, Fantastic, Superior, Extremely, Unique, Ideal etc. (b) contain any false claim, direct or indirect, that a product is „natural, nature‟s remedy‟ or the like. (c) lead consumers to over-estimate the value of a product whether by exaggeration or through unrealistic comparisons. (d) highlight the flavor or the attractiveness of the article expressly or by implication.

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5.7.2. Use of Certain Words or Phrases The uses of the following words or phrases in the advertisement of a product are not acceptable. (a) (b) (c) (d) (e) (f) (g) (h) (i) Safe, safely, safety Guarantee, Ensure Magic, magical, miracle, miraculous Remedy, cure No side effects No harmful effects No toxic or adverse effects 100% Natural / Herbal / Pure NEW [Can only be used in case of changes in packing, container, logo, or flavour. All changes must be approved by the Drug Control Authority (DCA).] The Medicine Advertisements Board reserves the right to disallow any other words or phrases which in its opinion is misleading, improper or not factual. 5.8. Specific Claims 5.8.1. Sexual weakness, Ageing, Loss of Virility Advertisements should not suggest or imply that any product offered will: (a) promote sexual virility or be effective in treating sexual weakness, lost of virility or habits associated with sexual excess or indulgence, or any ailment, illness or disease associated with such habits.

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(b)

retard, control or treat premature ageing or any other words or phrases to that effect

(c)

retard, control or reverse the process of ageing.

5.8.2. Loss of Hair, Baldness etc. No advertisement should contain any claim or implicating that:(a) (b) (c) baldness can be prevented or cured hair loss or thinning of the hair can be arrested or reversed or reduced hair growth can be stimulated or improved.

5.8.3. Control of Dandruff Advertisements for a product or treatment offered for the control of dandruff should not contain any claim or implication that the condition can be permanently prevented. Nor should such advertisement contain any exaggerated claim or implication as to its effectiveness. 5.8.4. Weight reduction/loss Weight reduction/loss products advertisement is not allowed in television media. For any other media, these products advertisement is allowed as approved by the Medicine Advertisements Board. 5.8.5. Vitamins (a) No advertisement should state or imply that good health is likely to be endangered solely because people do not supplement their diets with vitamins. (b) Advertisements should not contain any unqualified claims that vitamins will give adequate protection against or treatment of viral
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infections, or unqualified statement that the medical profession supports such claims. 5.8.6 Functional claims Only allowed for the claims and conditions of use as approved by Drug Control Authority. 5.8.7. Diseases or Conditions of Human body a) Only the indications as approved by DCA are allowed. b) All advertisements, unless approved by the Medicine Advertisement Board should not refer to any product which can be used to prevent, diagnose or treat conditions of human body. 5.9. Special/Cautionary Statements The Medicine Advertisement Board may require cautionary statements to be included in the advertisement. 5.9.1. Advertisements of: (a) products containing herbs or herbal material should include the following sentence: “This is a herbal preparation”

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(b)

products containing alcohol for its pharmacological effect or as a solvent should state the percentage content of such alcohol as follows:“This preparation contains X % alcohol” Methanol or methyl alcohol should not be present in products to be taken internally / orally.

(c)

products containing substances of animal origin should state the source of such substances by specifying the part or organ and the name of the relevant animal.

(d)

products containing specially formulated fat, soluble vitamins for use as supplements should include the following cautionary statement: “Excessive vitamin intake may be detrimental to your health”

(e)

products containing aspirin should include the following cautionary statement: “Not to be taken by children below 16 years old”

(f)

products for the relief of fever, cough and pain should include the following statement “If symptoms persist, please consult your doctor”

(g)

medical self-diagnostic appliances such as blood-pressure measuring watch, etc should include the following statement: “Please consult doctor for interpretation of the result”

(h)

products for weight reduction / weight loss should include the following statement:

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“This is a traditional preparation. Should be taken with a balanced diet and regular exercise” 5.10. Competition, Free Gift, Free Offer, Premium, etc. 5.10.1. Advertisements should not: (a) encourage, directly or indirectly, indiscriminate, unnecessary or excessive use of products. (b) contain any reference, directly or indirectly to any prize competition, free gift, free offer, premium, exchange scheme or any other similar scheme. (c) offer or describe any product as free or available free for trial as an incentive. (d) contain any reference to the free offer of a product with the purchase of a similar or other product.

5.11. Mail Order/Information by Correspondence (a) (b) Mail order advertising for a medical product should not be permitted. Advertisements should not contain any offer to diagnose, prevent or treat any diseases or conditions of the human body or symptoms of ill-health by correspondence nor invite information in order to advise on diagnosis, prevention or treatment by correspondence. (c) advertisements should not invite or induce viewers and readers to obtain information about products for the diagnosis, prevention or treatment by
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correspondence. 5.12. Direct Sale from Manufacturer, Wholesaler or Representative 5.12.1. An advertisement that encourages direct sale of a medical product to any individual from the manufacturer, wholesaler or representative is not allowed. 5.12.2. Home or office visits for the advertisement of a medical product is not allowed whether solicited, unsolicited or otherwise. 6. Others 6.1 Press release (a) Allowed for launching of new chemical entities (NCE). Allowed once only in newspapers. The launch can also be broadcasted. The contents are as approved by the Medicine Advertisements Board. (b) The contents for the press release of New Chemical Entity (NCE) are: (i) Indications as approved by Drug Control Authority (DCA) (ii) Cost per dose (iii) List of reference journals (c) Criteria for NCE are: (i) New drugs (ii)New combination of active pharmaceutical ingredients (iii)Available in Malaysia for the first time (iv)New indication(s)

(Note: All products must be registered with DCA)

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(d) The following informations are not allowed: (i) Reference to any medical practitioner endorsing or promoting the product (ii)Superlative words/statements (eg: the first, the best, the only one,etc) (e) The validity period is 3 months from the date of Approval. (f) The frequency of the press release shall be once only and release simultaneously in all media. 6.2 Advertorial Advertorial for poison products is not allowed. Advertorial for generic or active ingredients of OTC and traditional products are allowed. No mention of product name, brand or proprietary name. Only company name and logo is allowed. 6.3 Journal References Allowed only for advertisement in the form of leaflets, pamphlets and brochures 6.4 Product & pricing advertisement. MAB approval is not required if the advertisement contains only the picture and price of the products. It is mandatory to print the DCA registration number of the products.

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7. Review The Board can review the guideline from time to time. Note: Reviewed and approved by the Medicine Advertisement Board at the MAB 7/2007 meeting on 17th July 2007.This amended guidelines takes effect on 1st August 2007.

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