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
Advertisements 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, and remedies determined to be legally available without a
prescription.

(b)

take into account of peoples legitimate desire for information

regarding their health.

(c)

not take undue advantage of peoples concern for their health.

3. Authority
3.1

The Medicine Advertisements Board (MAB) may, at its discretion, issue

or refuse to issue any approval for advertisements to be publicised or may
cancel any approval which was 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.

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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
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.

4.2

b)

practicing contraception among human beings:

c)

improving the condition or functioning of the human kidney or heart,

or improving the sexual function or sexual performance of human
beings:

d)

procuring the miscarriage of women.

No product which is a poisons or contains 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 Advertisements
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 statement 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; or

(b)

contain statements giving the impression of professional by

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 diagnosis or treatment suffer, or suffer more severely,
from 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 not be allowed.

(d)

directly
or
by
implication
exploit
requirement/beliefs of any community.

the

religious

5.1.4 Acts of Violence or Illegal Activities

Advertisements should not contain anything, which might lead or
lend support to acts of violence, criminal or illegal activity nor should
they appear to condone such acts or activities.

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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.

(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, morallyl; 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:

5.3

(a)

the trade description;

(b)

official or other recognition of approval or certification.

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
named professional or official organization is permissible only if authorized

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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)

(b)

5.5

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.
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.

Testimonials
No advertisement for a product may include a testimonial:

5.6

5.7

(a)

by a professional or scientific association, body or organization.

(b)

by a person well-known in public life, sport, entertainment,

professional or scientific bodies, associations, organizations etc.

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.

(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.

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.

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(b)

contain any false claim, direct or indirect, that a product is

natural, natures 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.

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)

Effective, Efficacious, Efficacy Proven

Guarantee, Ensure
Magic, magical, miracle, miraculous
Remedy, cure
No side effects
No harmful effects
No toxic or adverse effects
100% 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.

(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.

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5.8.2 Loss of Hair, Baldness etc.

No advertisement should contain any claim or implicating that:(a) baldness can be prevented or cured
(b) hair loss or thinning of the hair can be arrested or reversed or
reduced
(c) hair growth can be stimulated or improved.
5.8.3 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.
5.8.4 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 infections, or unqualified statement that the medical
profession supports such claims.

5.8.5 Functional claims

Only allowed for the claims and conditions of use as per label
approved by Drug Control Authority.
5.8.6 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

(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:
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.

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(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)

Mail order advertising for a medical product should not be permitted.

(b)

Advertisements should not contain any offer to diagnose, prevent or

treat any diseases or conditions of the human body or symptoms of illhealth 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
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 information is 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 released
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 is for price lists that
contain only the picture [of which the product image is less than
4cm x 5cm] and price of the products. It is mandatory to print the DCA
registration number of the products.
7. Review
The Board can review the guideline from time to time.
Note:
Reviewed and approved by the Medicine Advertisements Board at the MAB
11/2008 meeting on 18th November 2008. This amended guideline takes
effect on 1st December 2008.

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