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									          1 DECEMBER 2010


          A GUIDE ON
   ADVERTISEMENTS AND SALES
PROMOTION OF MEDICINAL PRODUCTS
 ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS                                      DECEMBER 2010



                                        CONTENT PAGE


PART I – GENERAL INFORMATION .........................................................................3 

1.  INTRODUCTION .................................................................................................3 
2.  OBJECTIVE .........................................................................................................3 
3.  ADVERTISEMENTS REQUIRING PERMITS FROM THE HEALTH
     SCIENCES AUTHORITY .....................................................................................3 
4.  CLASSES OF ADVERTISEMENTS ....................................................................3 
5.  TYPES OF APPLICATIONS ................................................................................4 
6.  VALIDITY OF PERMIT ........................................................................................6 
7.  FEES ...................................................................................................................6 
8.  APPLICATION PROCEDURE .............................................................................7 
9.  PUBLISHING AN ADVERTISEMENT OR CONDUCTING A SALES
     PROMOTION.......................................................................................................8 
10.  EXEMPTIONS TO ADVERTISEMENT PERMITS ...............................................9 

PART II – GUIDELINES ON MEDICAL ADVERTISEMENTS AND SALES
PROMOTIONS .........................................................................................................10 

1.    GENERAL PRINCIPLES ...................................................................................10 
2.    PROHIBITED ADVERTISEMENTS ...................................................................13 
3.    PRODUCT NAMES NOT ALLOWED FOR ADVERTISING ..............................14 
4.    TERMS AND CLAIMS NOT ALLOWED FOR ADVERTISING...........................15 
5.    ADDITIONAL GUIDELINES FOR SPECIFIC PRODUCTS ...............................16 

PART III - OFFENCES & PENALTIES......................................................................18 

1.  THE MEDICINES ACT 1975..............................................................................18 
2.  THE MEDICINES (MEDICAL ADVERTISEMENTS) REGULATIONS 1977 ......18 




  HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP                                   Page 2 of 19
ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS         DECEMBER 2010


              PART I – GENERAL INFORMATION

1.    INTRODUCTION
This guide is intended to complement the provisions of the Medicines
(Medical Advertisements) Regulations 1977 and the Singapore Code of
Advertising Practice relating to the advertising and sales promotion of
medicinal products for human use in the public media or intended for the
information of the general public.


2.    OBJECTIVE
The objective of advertisement control of medicinal products is to ensure that
medicinal products advertised or promoted for sale do not adversely affect
public health, mislead or induce unnecessary use.


3.    ADVERTISEMENTS REQUIRING PERMITS FROM
      THE HEALTH SCIENCES AUTHORITY
Any advertisement or sales promotion that relates to or is likely to cause any
person to believe that it relates to any medicinal product requires prior
approval from the Health Sciences Authority.


4.    CLASSES OF ADVERTISEMENTS
(a)   Still

      Includes any advertisement in print media, e.g. newspapers,
      magazines, leaflets, brochures, billboards, posters, banners, shelf-
      talkers, wobblers, stickers, display racks, stands or trays, lighted-
      boxes, mail order announcements or calendars.

(b)   Sound

      Includes any advertisement broadcast over radio, or any audio
      recordings.

(c)   Light and Sound

      Includes any advertisement with light and sound effects, e.g. television,
      cinema advertisements, filmlets, videos.



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(d)   Sales Promotion

      Includes any activity with the purpose of introducing, publicising or
      promoting the sale of a medicinal product e.g. price-off, banded offers.

      (i)    Sales promotions that are allowed:

                giving discounts

                banding of different pack sizes of the same medicinal
                 product or medicinal product within the same range, with or
                 without a discount

                distribution of samples of vitamin and mineral products,
                 medicated oils and balms, medicated plasters, antiseptic
                 preparations, medicated soaps (subject to approval).

      (ii)   Sales promotions that are not allowed:

                offering of gift or prize to promote sales of a medicinal
                 product. The word “free” or “complimentary” (免 费 或 附 送 )
                 is also not allowed

                use of money-back guarantee

                offer of medicine free-of-charge with the purchase of a non-
                 medicinal product.

                distribution of samples of medicinal products (e.g. Pharmacy
                 Only, General Sales List, Chinese Proprietary Medicines and
                 Traditional Medicines) to the general public.


5.    TYPES OF APPLICATIONS
(a)   New Application

      A new application is defined as an application for an advertisement or
      sales promotion.

      Advertisement:

      (i)    If an advertisement comes in one copy in more than one
             language, only 1 application is required.

      (ii)   If an advertisement comes in more than one copy, each in a
             different language, separate applications will be required. As an
             example, for a leaflet that comes in two copies, one in English
             and one in Chinese, 2 applications would need to be made.

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      (iii)   If an advertisement also contains a sales promotion
              announcement, an application for sales promotion would also be
              required. Both the advertisement permit (MAHPxxxxxxx) and
              sales promotion permit (MAHSxxxxxxx) numbers have to be
              legibly printed on the advertisement.

      Sales Promotion:

      (i)     Only 1 application is required for the sales promotion of products
              in the same range (e.g. different brands of vitamins, up to a
              maximum of five products) using the same promotional method.

      (ii)    A copy of the sales promotion mechanics is to be submitted in
              the application.

              The prescribed format is as follows:

                 Name of Product
                 Promotion Method (e.g. price discount)
                 Press Advertisement, if any (to provide a draft artwork as an
                  attachment)
                 Promotion Materials (e.g. shelf-talker, wobbler), if any (to
                  provide as an attachment)
                 Promotion Venue (e.g. retail pharmacy, shopping centre)
                 Promotion Period (e.g. within validity of permit)

(b)   Amendment

      An amendment is defined as an application for a minor alteration of an
      advertisement and sales promotion, or change of particulars of the
      applicant.

      (i)     Minor alterations of advertisement and sales promotion permit
              include:

                 minor change of text, inclusion or omission of some words
                 minor change in the visuals

      (ii)    Amendment is not required for minor re-arrangement of the text
              and pictures in an approved advertisement.

      (iii)   Amendment is not required for updating company’s address and
              telephone numbers in an approved advertisement.

      (iv)    Change of company and applicant particulars of permit holders
              is free-of-charge under amend@prism:

                     Amend Company Information
                     Amend Applicant’s Details

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      (v)    If the alterations proposed are major, applicants would need to
             apply for a new permit.

      (vi)   The validity of the permit upon amendment remains the same as
             the original approval.

(c)   Renewal

      A renewal is defined as an application for an advertisement whose
      permit is nearing its expiry date and the applicant wishes to renew the
      advertisement.

      A renewal notification and reminder will be sent to the company 60
      days and 45 days, respectively, before the expiry date of permit.

      (i)    For GIRO linked companies:

                The permit will be automatically renewed unless the
                 company opts out from the renewal by the given date stated
                 in the renewal notification.

                Select ‘Auto Renewal Preference’ function to opt out of auto-
                 renewal.

                If the opt out is successful, an acknowledgment statement
                 will be displayed after clicking the Save button, i.e. 'The
                 record is updated successfully'.

                There is no refund for cancellation of renewed permits.

      (ii)   For non-GIRO linked companies:

                Select ‘Renew Medical Advertisement and Sales Promotion
                 Permit’ to submit a renewal for the permit

                The permit will expire if it is not renewed by the given date
                 stated in the renewal notification.


6.    VALIDITY OF PERMIT
Each permit is valid for 1 year from the date of issuance of permit approval.


7.    FEES
Effective Date: 1 February 2007


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ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS             DECEMBER 2010


          1    Application for a permit for ---
                (a) an advertisement in still media                 $100
                (b) an advertisement in sound media                 $100
                (c) an advertisement in light & sound media         $200
                (d) a sales promotion                               $100


          2    Permit for ---
          (i) the first year for ---
                (a) an advertisement in still media                 $100
                (b) an advertisement in sound media                 $100
                (c) an advertisement in light & sound media         $100
                (d) a sales promotion                               $100


          (ii) each subsequent year for ---
                (a) an advertisement in still media                 $200
                (b) an advertisement in sound media                 $200
                (c) an advertisement in light & sound media         $300
                (d) a sales promotion                               $200


          3    Application to amend a permit                        $50

      Note:

             The schedule of fees chargeable is also available on the Authority’s
              website.
              http://www.hsa.gov.sg/ma

             Application fee is non-refundable.

             Amendment fee is non-refundable.


8.    APPLICATION PROCEDURE
All applications for advertisement and sales promotion permit should be
submitted via the online system on the Authority’s website, i.e. PRISM -
Pharmaceutical Regulatory Information System.

(a)   A company who first applies for a license/permit with the Authority is
      required to register with CRIS – Client Registration and Identification
      Service (cris@hsa):

      http://www.hsa.gov.sg/cris.html

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(b)    A Singpass or HSA PIN is required to login the PRISM system for
       authentication and authorization.

(c)    The modes of payment include GIRO and credit card.

(d)    Application of Medical Advertisements and Sales Promotion Permit:

       (i)     Go to prism@hsa

               http://www.hsa.gov.sg/prism

       (ii)    Select ‘Medical Advertisements and Sales Promotion’.

       (iii)   Go to ‘Make an application’.

       (iv)    Go to ‘Apply for Medical Advertisements and Sales Promotion
               Permit’.

       (v)     Click [View guide] to preview the online application form in plain
               text.

       (vi)    Click ‘Apply for Medical Advertisements and Sales Promotion
               Permit’ to make a new application.

(e)    The processing time for each application is 14 working days, excluding
       time taken by applicant to make required changes.

(f)    Upon successful submission of an application via PRISM, an
       acknowledgement with an application number will be generated. The
       application number is not a permit number.

(g)    If the application is approved, a permit number will be issued with an
       endorsed copy of the advertisement or sales promotion.


9.     PUBLISHING   AN    ADVERTISEMENT                                       OR
       CONDUCTING A SALES PROMOTION
Before a medical advertisement is published or a medical sales promotion is
conducted, it is mandatory for the company initiating the advertisement and
the publisher, media owner or the organiser(s) of the sales promotion to
ensure that:

(a)    the advertisement or sales promotion has a valid permit from the
       Health Sciences Authority

(b)    the permit number is printed legibly on the advertisement and
       promotional materials


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(c)   the advertisement has not been amended without prior written
      permission from the Health Sciences Authority.


10. EXEMPTIONS TO ADVERTISEMENT PERMITS
(a)   The following types of advertisements relating to a medicinal product
      do not require a permit from the Health Sciences Authority:

      (i)      Package inserts accompanying the product

      (ii)     Announcements and warnings on imitation of medicinal products
               with no intent to advertise the product

      (iii)    Announcements on the name and address of a new distributor

      (iv)     Display cards on product shelves printed with only the name of
               the medicinal product and the price (not the special or
               discounted price)

      (v)      Packaging with a protruding display flap, containing a single unit
               of medicinal product

      (vi)     Reference advertisements – product information pertaining to
               the safe and correct use of a medicinal product, published by a
               person or company with no commercial interest in the product,
               for dissemination to practitioners and pharmacists

      (vii)    Trade advertisements – defined as a document for the purpose
               of a sale by way or wholesale dealing which does not contain
               any recommendations on product use.

      (viii)   Promotional materials for dissemination to healthcare
               professionals only. It should be stated clearly on the materials
               that they are for healthcare professionals only and not for
               general circulation.

(b)   The following sales promotion does not require permit from the Health
      Sciences Authority:

      (i)      Distribution of samples or bonus offers to drug stores,
               pharmacies, wholesalers and clinics, provided that there is no
               sales promotion to the general public.

      (ii)     Storewide sales promotion that is not specific to any product by
               named basis.

Note: The Authority may when it deems necessary, in the interest of public
safety, subject any of the above types of activities to regulatory control.

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 ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS         DECEMBER 2010



     PART II – GUIDELINES ON MEDICAL
 ADVERTISEMENTS AND SALES PROMOTIONS

1.     GENERAL PRINCIPLES
(a)    Truthfulness

       Advertisements should truthfully state the nature, quality and properties
       of the medicinal product. Advertisements should not mislead in any
       way by ambiguity, exaggeration, omission or otherwise.

(b)    Substantiation

       All claims made in the advertisement must be substantiated. The
       literature should be of established sources, e.g. Martindale, peer
       reviewed scientific journals.

(c)    Accuracy

       Recommendations relating to the use of medicinal products should be
       accurately stated in moderate terms and should be relevant to their
       properties.

(d)    Comparisons

       Advertisements should not contain comparisons with other medicinal
       products or related products unless scientifically proven.

(e)    Indiscriminate Use

       Advertisements should not directly or indirectly encourage
       indiscriminate, unnecessary or excessive use of the medicinal product.

(f)    Use of Scientific Data

       Advertisements should not exploit the ignorance and credulity of the
       public by including scientific data that the general public cannot verify
       or validate. Advertisements should not misuse research results or
       make unnecessary quotations from technical and scientific
       publications.

(g)    Fear and Superstition

       Advertisements should not arouse fear in the minds of the public nor
       should they exploit the public’s superstition.


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(h)    Language

       Medical advertisements should be in simple-to-understand language,
       easily comprehensible and should avoid confusing medical jargon.
       Scientific jargon and irrelevancies should not be used to make claims
       appear to have a scientific basis they do not possess.

(i)    Refund

       No advertisement should contain any offer to refund money to
       dissatisfied users.

(j)    Trial Use

       Advertisements should not suggest trial use of medicinal products.

(k)    Pregnant or Lactating Women

       Advertisements should not suggest or recommend any medicinal
       product, with the exceptions of some vitamin or mineral supplements,
       for use by pregnant or lactating women.

(l)    Endorsements and Testimonials from Healthcare Professionals

       Advertisers should not give the impression of advice or support from
       healthcare professionals, i.e. visual and/or audio presentation of
       doctors/dentists/pharmacists or nurses on the medicinal product.
       Advertisements should not carry testimonials or recommendations by
       healthcare professionals.

(m)    Endorsements and Testimonials from Public Figures

       Advertisements to the general public should not give the impression of
       advice or support from public figures (e.g. celebrities), i.e. visual and/or
       audio presentation of public figures on the medicinal products, except
       when prior approval or permit is granted by the Authority.

(n)    Testimonials by Non-professionals

       These are generally not allowed unless the claims in the testimonials
       can be substantiated.

(o)    Logos, Initials and Trademarks

       Advertisements should not make use of names, initials, logos and/or
       trade service marks of any firm, company or institution. The advertiser
       must submit the written permission from the concerned firm, company
       or institution on the use of their names, initials, logos and/or trade
       service marks before it can be approved.

  HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP        Page 11 of 19
 ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS         DECEMBER 2010

       The names and logos of the Health Sciences Authority and any of its
       professional groups cannot be used for any medicinal product
       advertisement and sales promotion in any media (printed, sound and
       light & sound).

(p)    Normal Lifestyle

       Advertisers should not give the impression that normal lifestyle needs
       the use or consumption of a particular medicinal product.

(q)    Stress

       Advertisers should not claim that the use of a particular medicinal
       product is needed to prevent/reduce the stress of modern living.

(r)    Performance in Sports and Studies

       Advertisements should not imply that the consumption of a particular
       medicinal product can improve performance in sports and studies.

(s)    Cure

       There should not be any words, phrases, or illustrations in
       advertisements which claim or imply the cure of any ailment, illness or
       disease other than from the relief of its symptoms.

(t)    Reference to Love and Friendship

       Advertisements should not depict that the use of a particular medicinal
       product can affect one’s love life or friendship with others.

(u)    Anti-ageing

       There should not be direct or indirect suggestion that a particular
       medicinal product can prevent, retard or reverse the physiological
       changes and degenerative conditions brought about by or associated
       with ageing.

(v)    Reference to Sexual Function

       There should not be any implication that a medicinal product can
       induce sexual virility or they are effective in treating sexual weakness
       or sexual excess. No reference should be made to premature
       ejaculation.

(w)    Discourage from Medical Advice

       Advertisements should not in any way discourage the public from
       seeking the advice of a medical professional.

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(x)   Conformance with SCAP

      All medical advertisements must also comply with the Singapore Code
      of Advertising Practice (SCAP) drawn up by the Advertising Standards
      Authority of Singapore.


2.    PROHIBITED ADVERTISEMENTS
(a)   No advertisements are allowed for any product or article with any direct
      or indirect reference to the list of 19 diseases and conditions listed in
      the First Schedule to the Medicines Act. These are:

         Blindness (失 明)
         Cancer (癌 症)
         Cataract (白 内 障)
         Drug addiction (毒 瘾)
         Deafness (耳 聋)
         Diabetes (糖 尿 病)
         Epilepsy or fits (癫 痫 或 抽 搐)
         Hypertension (高 血 压)
         Insanity (精 神 错 乱)
         Kidney diseases (肾 病)
         Leprosy (麻 风)
         Menstrual disorders (月 经 不 调)
         Paralysis (瘫 痪 症)
         Tuberculosis (结 核 病)
         Sexual functions (性 机 能)
         Infertility (不 育 症)
         Impotence (阳 萎)
         Frigidity (性 冷 感)
         Conception and pregnancy (受 孕 或 怀 孕)

(b)   Other diseases / conditions not allowed in advertisements are:

         AIDS (爱 滋 病)
         Arteriosclerosis (动 脉 硬 化)
         Glandular inflammation (腺 炎) e.g. parotid, thyroid

 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP     Page 13 of 19
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         Heart or cardiovascular disease (心 管 疾 病)
         Hepatitis (肝 炎)
         Hernia (疝)
         Insomnia (失 眠)
         Neuralgia (神 经 痛)
         Osteoporosis (骨 骼 疏 松 症)

      Note: The above prohibitions are not exhaustive and may be subject to
      change.


3.    PRODUCT NAMES                       NOT        ALLOWED            FOR
      ADVERTISING
(a)   Names with sexual implications,

      e.g.   Aphrodisiac Wine (壮阳春酒)

(b)   Names that are exaggerated or misleading,

      e.g.   Ageless Anti-aging Capsules (防 衰 益 寿 丸 ,抗 老 延 年 丸)
             Celestial Syrup (仙 露)
             Cure–all Children’s Pill (小 儿 万 应 丸)
             Disease Prevention Pill (防 病 丹)
             Epidemic Infection Clearing Tablet (清 瘟 解 毒 片)
             Instant Sports Power
             Life-saving Wine (救 命 药 酒)
             Magic Pills (神 丹)
             Recreate Pill (再 造 丸)
             Smart Tablet (聪 明 片)
             Stress Tab
             Study Pills (读 书 丸)
             Treasure of Life (命 之 宝)


(c)   Names relating to a vital body organ, their functions or disease
      conditions,

      e.g.   Heart Rescue Pill (救 心 丸)

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             Lung Cure Herb (肺 辽 草)

(d)   Names which specify substances that are not found in the product.

Note: The above prohibitions are not exhaustive and may be subject to
change.


4.    TERMS AND CLAIMS NOT ALLOWED FOR
      ADVERTISING
(a)   Superlatives,

      e.g.   Miraculously
             The only medicine to use or cure
             World’s best
             100% safe
             No side effects

(b)   Exaggerated claims,

      e.g.   Clinically proven (unless substantiated)
             Clinical trials (临 床 试 验) (unless substantiated)
             Complete cures
             Cure when other treatment fails (唯 一 良 药)
             Guaranteed (保 证)
             Improve sex life
             Increase / improve memory
             Instant cure (马 上 见 效)
             Other drugs / products cannot compare with it
             Perpetual youth
             Scientifically proven (科 学 证 明) (unless substantiated)
             Sensational relief
             The No. 1 (unless substantiated)


(c)   Misleading claims,

      e.g.   Anti-aging

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             Anti-stress
             Arousal, Libido
             Boost immunity
             Breast enhancement and enlargement
             Height growth
             Intelligence and memory enhancement
             Longevity
             Sexual organs and function enhancement
             Stimulation of hormone production

Note: The above prohibitions are not exhaustive and may be subject to
change.


5.    ADDITIONAL              GUIDELINES               FOR      SPECIFIC
      PRODUCTS
(a)   Medicines that require a doctor’s prescription

         No advertisement or sales promotion is allowed to the general
          public.

(b)   Medicines sold in pharmacies only

         Recommendations relating to the use of the product should be
          consistent with the Authority’s approved indications.

         Sales promotion materials for Pharmacy-Only Medicines (P) are
          restricted to the pharmacy dispensary only.

(c)   Medicines sold over-the-counter (OTC)

         Recommendations relating to the use of product should be
          consistent with the Authority’s approved indications.

(d)   Vitamins and Minerals

         No advertisement will be allowed for statements that claim that
          there is evidence of general widespread vitamin deficiency.

(e)   Raw Medicinal Herbs

         A guidance on advertisements of raw medicinal herbs can be found
          on the Authority’s website.

          http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulat
          ion/medical_advertisements/guidelines.html
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(f)    Health Supplements, Medical Devices and Cosmetics

          Other guidelines and references can be found on the Authority’s
           website under Health Products Regulation in various sections:

           e.g. Guidelines for Health Supplements, under ‘Complementary
                Medicines’.
                 Regulatory Framework for Medical Devices, under ‘Medical
                 Devices’.
                 ASEAN Cosmetic Claims Guidelines,               under ‘Cosmetic
                 Products’.

(g)    Melatonin

          The only advertisement claim allowed is for the use in jet lag.
          The advertisement should contain the cautionary statement:
           “Not suitable for children, pregnant and lactating women.”

(h)    Red Yeast Rice Products

          The advertisement should contain the cautionary statement: “This is
           a Chinese Proprietary Medicine/Health Supplement product.
           Please consult your physician if you are taking other medications.”

(i)    Slimming Products

          The advertisement should contain the advisory statement: “Use in
           conjunction with a balanced diet and regular exercise.”




  HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP       Page 17 of 19
ADVERTISEMENT AND SALES PROMOTION OF MEDICINAL PRODUCTS          DECEMBER 2010


          PART III - OFFENCES & PENALTIES

1.    THE MEDICINES ACT 1975
Any person who contravenes the following provision of the Act shall be guilty
of an offence and shall be liable to a fine not exceeding $5,000 or to
imprisonment for a term not exceeding 2 years or to both:

Section 51(1)(a) - Advertisements on any diseases or conditions specified in
the First Schedule of the Act. (See Page 13)


2.    THE MEDICINES (MEDICAL ADVERTISEMENTS)
      REGULATIONS 1977
Under the Medicines (Medical Advertisements) Regulations 1977, any person
who contravenes the following regulations shall be guilty of an offence and
shall be liable to a fine not exceeding $5,000 or to imprisonment for a term not
exceeding one year or to both:

(a)   Regulation 3 - Advertising or conducting sales promotion without a
      valid permit from the licensing authority.

(b)   Regulation 8 - Publishing medical advertisements which do not have
      valid permits.

(c)   Regulation 9 - Offering of gift or prize in conjunction with the sales
      promotion.

(d)   Regulation 12 - Issuing or publishing medical advertisements without
      reflecting the permit number on the advertisement.

(e)   Regulation 13 - Altering or amending advertisements which have valid
      permits without the written approval of the licensing authority.




 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP      Page 18 of 19
Contact Officer:

Christine Choo
Regulatory Executive
Medical Advertisements Unit
Vigilance, Compliance & Enforcement Division
Health Products Regulation Group
Health Sciences Authority


11 Biopolis Way, #11-03 Helios
Singapore 138667
www.hsa.gov.sg
T: 6866 3478
F: 6478 9038

								
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