Guidelines for control of promotion, adv ertisement and marketing  
Of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date: 23/07/2021    
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDELINES FOR CONTROL OF PROMOTION, 
ADVERTISEMENT AND MARKETING OF 
MEDICINES, MEDICAL DEVICES AND COSMETICS 
IN RWANDA  
 
 
 
 
JULY   2021  
 
 
Guidelines for control of promotion and advertisement  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date: 23/07/2021    
  
GUIDELINES DEVELOPMENT HISTORY  
 
DRAFT ZERO  20/05/2018  
ADOPTION BY RWANDA FDA  08/07/2020  
STAKEHOLDERS CONSULTATION  16/10/2020  
ADOPTION OF STAKEHOLDERS’ COMMENTS  24/11/2020  
DATE FOR COMING INTO EFFECT  23/07/2021  
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 3 of 30  
FOREWORD  
 
Rwanda Food and Drugs Authority is a regulatory body established by the Law N° 003/2018 of 
09/02/2018. One of the m issions of Rwanda FDA, especially in its article 8, paragraph 11, 
whereby the authority is mandated  to regulate and analyze information used in the promotion, 
advertising and marketing of regulated products;  
 
Considering  the provisions  of the technical  regulation No CBD/TRG/017 Rev0 governing the 
promotion and advertisement of regulated products especially in its article 8, paragraph 11, the 
authority has to issue these guidelines for control of promotion, advertisement and marketing of 
regulated  products.  
 
Promotion , advertisement  and marketing  of regulated products remains an important means of 
step-by-step planning that involves Produc t, Price, Place and Promotion also known as “The four 
Ps” to create  awareness and disseminate  information to the public an d healthcare professionals. It 
also provides a means of updating all on the latest advances and availability and rati onal use of 
regulated products.  
These guidelines will provide the necessary information on the current minimum requirements 
for promotion , advertisement  and marketing  authorization of both conventional and alternative 
medical  products including  human and veterinary products, medical devices and medicated 
cosmetics in Rwanda. Therefore, guidelines stipulate, among other things, elements of 
advertisement, promotion and marketing, restrictions therein, basic requirements and the 
application procedures for obtaining approval to promote , advertise , and market regulated 
products  by Rwanda FDA.   
 
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 4 of 30 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 5 of 30  
ACC RONYMS AND ABBREVIATIONS  
 
Rwanda FDA:    Rwanda Food and Drugs Authority  
POM:    Prescription Only Medicines for Humans  
POM -V:   Prescription Only Medicines Veterinary  
GDP                                        Good Distribution Practices  
MAH                                      Marketing Authorization Holder  
Non POMV -V:  Non Priscription Only Medicines Veterinary  
SPCs:    Summaries of Product Characteristics.   
OTC:    Over The Counter  
Authority:               Rwanda Food and Drugs Authority  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 6 of 30  
TABLE OF CONTENTS  
GUIDELINES DEVELOPME NT HISTORY  ................................ ................................ ............  2 
FOREWORD ................................ ................................ ................................ ................................ . 3 
ACCRONYMS AND ABBREV IATIONS  ................................ ................................ ..................  5 
TABLE OF CONTENTS  ................................ ................................ ................................ .............  6 
GLOSSARY ................................ ................................ ................................ ................................ ... 8 
1.1. INTRODUCTION ................................ ................................ ................................ ................  11 
1.2. SCOPE  ................................ ................................ ................................ ................................ .. 11 
1.3. PROHIBITIONS ON PROM OTION, ADVERTISEMENT  AND MARKETING  ....... 12 
1.4. GENERAL REQUIREMENTS  FOR PROMOTION, ADVE RTISING AND 
MARKETING OF MEDICAL  PRODUCTS  ................................ ................................ ...........  13 
1.5. SPECIAL REQUIREMENTS  ................................ ................................ ............................  14 
1.5.1. REQUIREMENTS FOR PROMOTION, ADVER TISING AND MARKETING  OF 
MEDICINES  ................................ ................................ ................................ ...............................  14 
1.5.2 VETERINARY MED ICINES  ................................ ................................ ..........................  16 
1.5.3 REQUIREM ENTS FOR PROMOTION, ADVERTESING  AND MAR KETING OF 
MEDICAL DEVICES  ................................ ................................ ................................ ................  16 
1.5.4  REQUIREMENTS FOR PRO MOTION , ADVERTISING  AND MARKETING OF  
REGULATED COSMETICS  ................................ ................................ ................................ .... 17 
2.0. TARGETED AUDIENCE IN  PROMOTION, ADVERTIS EMENT AND 
MARKETING  ................................ ................................ ................................ .............................  19 
3.0. MODE OF PROMOTION, A DVERTISEMENT AND MAR KETING  ........................  21 
3.1 REQUIREMENTS FOR  PROMOTION  AND ADVERTISEMENT   APPLICATIONS
................................ ................................ ................................ ................................ .......................  22 
4.0. STAKEHOLDERS  RESPON SIBILITIES  ................................ ................................ ....... 23 
4.1 MEDICAL AND PHARMACEUTICAL R EPRESENTATIVES  ................................ ..........................  23 
4.2 QUALIFICATION OF MEDI CAL REPRESENTATIVES  ................................ ................................ .. 23 
4.3 LOCAL GOVERNMENT AUTHORITIES AND LAW ENFOR CERS ................................ .................  24 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 7 of 30 4.4  HEALTHCARE PROFESSIONALS  ................................ ................................ ............................  24 
4.5  MEDIA  ................................ ................................ ................................ ................................ . 24 
4.6 GENERAL PUBLIC ................................ ................................ ................................ .................  24 
5.0. COMPLAINTS REGARDING  PROMOTED , ADVIRTIS ED AND MARKETED 
PRODUCTS ................................ ................................ ................................ ................................ . 25 
6.0 ENDORSEMENT OF T HE GUIDELINES  ................................ ................................ ....... 26 
ANNEX 2: APPLICATION FOR PERM IT TO CONDUCT PROMOT ION MEETING  .. 29 
ANNEX 3: COMPLAINT F ORM  ................................ ................................ .............................  30 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 8 of 30  
GLOSSARY  
In these guidelines, unless the context otherwise states:  
“Advertisement”  means a form of communication through the media about products, services 
or ideas by an identified sponsor which is used to encourage, persuade or manipulate an audience 
(viewers, readers or listeners) to continue with or take some new action  
“Advertising ” means anything that is aimed or designed to promote the supply, sale or use of a 
product whether or not for financial gain, and it includes but not limited to written 
communication materials (for instance a notice, circular, handouts,  wrappers, catalogues, bill 
boards, posters, newspapers, magazines, digital and social media posters  or other promotional 
document) and an audio (records, tapes, radio, ) or visual announcem ent (films, video recordings, 
television, internet, electronic media, interactive data systems,…).  
“Applicant”  means a person seeking approval to promote a medicine, medical device or 
promotion  
“Authority”  means the Rwanda Food and Drugs Authority, establi shed by the Law No. 
003/2018 of 09/02/2018.  
“Distribution” The procuring, purchasing, holding, storing, selling, supplying, importing, 
exporting, or movement of medical products, with the exception of dispensing or providing 
medical products directly to a client.  
‘‘Dispense’’  in relation to a medicine or poison, means supply a medicine or poison on and in 
accordance with a prescription duly given by a duly qualified medical practitioner, dentist or 
veterinary surgeon.  
“Marketing” means to promote, distribu te, sell, or advertise regulated products, or/and creating 
a relationship of the public and/or with information services regard to regulated products.  
“Medicine”  means any substance intended for human or veterinary use, presented in its finished 
dosage for m, that is subject to control by the Authority and includes medicinal product, 
pharmaceutical product, herbal medicines, veterinary medicine and related substances.  
“Product”  means medicine, medicinal product, pharmaceutical product, herbal medicines,  
veterinary medicine or related substances.   
“Pharmaceutical products”  means any substance capable of preventing, treating human or 
animal diseases and any other substance intended for administration to a human being or an 
animal in order to diagnose disease s, restore, correct or carry out modification of organic or 
mental functions. It also means products used in disinfecting premises in which drugs are 
manufactured, prepared or stored, cleaning hospitals, equipment and farm houses.  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 9 of 30 “Drug promotion”  means an y activity undertaken by any person or with its authority which 
promotes the prescription, supply, sale or administration of its products.  
“Promotional material”  means any representation concerning the attributes of a product 
conveyed by any means whatsoev er for the purpose of encouraging the usage of the product.  
“Regulated product”  means processed foods, pharmaceutical products, vaccines, human and 
veterinary processed foods and other biological products used in clinical as drugs, food 
supplements, food f ortification, fortified foods, poisonous substances, herbal medicines, 
medicated cosmetics, medical devices, tobacco and tobacco products.  
“Media”  means newspaper, magazine, medical/journal, television, radio, the Internet; Out of 
home, vehicle branding, p osters, handbills, cinema, point of sale material; online, digital and 
social media, any form of projected light and sound recordings or any of such means of 
communication.  
“General public”  means any person considered as a client or potential client . 
“Medi cal device”  any instrument, machine, appliance, material intended by  the manufacturer to 
be used alone or in combination for the purpose of diagnosis,  testing, vaccination, or  for 
cure,  surgery human  or animal  health  protection;  
“Misleading information”  means information  that gives a wrong idea or impression  
“Healthcare workers”  means medically qualified persons, including physicians, dentists, 
pharmacists, nurses, assistant medical officers and clinical officers, pharmacy technicians, 
laboratory technician s, laboratory technologists  and any other person who in the course of their 
professional activities may prescribe, supply or administer a drug or herbal drug  
“Herbal medicine”  a pharmaceutical product  with a label  identifying  its dosage  form that 
contains  one or more substances of natural origin that  are derived from  plants; 
“Label”  means any tag, brand, and mark, pictorial or other descriptive matter written, printed 
stencilled, marked, embossed or impressed on or attached to a container of any product  
 “A manufacturer”  means a company that carries out operation s such as production, 
packaging, repackaging, labelling and relabelling of products regulated by Authority  
"Medicine"  means any medicament or curative or preventive substance, whether proprietary o r 
in the form of a preparation;   
"Medicinal substance"  means any medicine, product, article or substance which is claimed to 
be useful for any of the following purposes:  
a) treating, preventing or alleviating disease or symptoms of disease;   
b) diagnosing dise ase or ascertaining the existence, degree or extent of a physiological 
condition; or   Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 10 of 30 c) preventing or interfering with the normal operation of a physiological function whether 
permanently or temporarily and whether by way of terminating, reducing, postponin g or 
increasing or accelerating the operation of the function in human beings or animals;  
“Manufacturer”  means a person or a firm that is involved in the production, preparation, 
processing, compounding, formulating, filling, refining, transformation, pac king, packaging, re -
packaging and labelling of drug and herbal drug.  
 
“Medical claim”  includes any statement that conveys information about a disease state or the 
attributes of a product in respect of its therapeutic use that is a use for the purpose of or  in 
connection with;   
a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal 
physical or mental state, or the symptoms thereof, in man or animal;  
b) restoring, correcting or beneficial modification of organic or mental functions  in man or 
animal; or  
c) disinfection in premises in which food and drugs are manufactured, prepared or kept, 
hospitals, equipment and farm houses;  
“Medical representative”  means a person expressly employed by a company whose main 
purpose is to promote the c ompany’s products.  
‘‘Prescription medicine''  means any product required to be dispensed only upon a prescription 
given by a medical practitioner, dentist or veterinary surgeon or any other person approved by 
the Minister;   
“Promotion”  is any communicatio n that attempts to influence people to buy or use the regulated 
products. It is the publicizing of a product so as to increase public awareness or sales using of 
audio -visual, oral or written material through advertising, sales promotion, direct marketing 
publicity, trade shows, promotional meetings, participation in exhibitions, giving samples, 
personal selling, etc.  
“Promotional material”  means any representation concerning the attributes of a product 
conveyed by any means whatever for the purpose of enc ouraging the usage of a product .  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
Doc. No.: DIS/GDL/050  Revision Date: 18/06/2021  Review Due Date: 23/07/2024  
Revision No.: 0  Effective Date:  23/07/2021    
Page 11 of 30 1.1. INTRODUCTION  
 
According to the law Nº 003/2018 of 09/02/2018 establishing Rwanda FDA, especially in its 
article 8, paragraph 11, the Authority is mandated to regulate and analyse information used in the 
prom otion, advertising and marketing of products regulated under this Law and in its article 9 
which give the powers of Rwanda FDA is formulate regulations and guidelines for regulating the 
manufacture, import and export, distribution, sale and use of regulate d products under this Law;  
 
These guidelines highlight general conditions and requirements for promoting , advertising  and 
marketing medicines, medical devices and cosmetics to the public and healthcare professionals, 
procedures for submission of applicatio n to promote regulated products. The guidelines are 
meant to be used by people in all walks of life, by governments, pharmaceutical industry 
(manufacturers, wholesalers and retailers), health professionals involved in prescription, 
dispensing, supply and d istribution of medicines, and consumer groups and the media including 
professional media such as publishers and editors of medical journals and related publications . 
 
Control of promotion , advertisement and marketing  of medicines, medical devices and cosme tics 
aims at ensuring that public and healthcare professionals receive the correct information about 
the products to help them make an informed decision on the choices and use of products. It also 
includes protecting from false, misleading or deceptive information  that would create erroneous 
impression for consumers . 
 
1.2. SCOPE  
 
These guidelines apply to the product  promotion, advertisement  and marketing  by 
manufacturers, wholesalers, retailer’s, dealer’s applicants and/or anyone wishing to advertise, 
promote o r market medicines or medical devices and medicated cosmetics in Rwanda. All 
advertisements, promotional and marketing material and information on medicinal products, 
medical devices and medicated cosmetics  available in Rwanda should comply with requiremen ts 
in order to protect the public health. The information thus provided should enable the health care 
professional and the patient in making appropriate decisions for the rational use of medicines  
The product promotion, advertisement  and marketing  must be aligned with the intended uses 
(indications), as per its registration . This can be in any forms or media, including but not limited 
to:  
- Aerial promotions such as on hot air balloons  
- Booklets  
- Cinema commercials  
- Consumer leaflets  
- Direct mail materials  
- Inter net materials, including press releases intended for internet publication  
- On-pack statements  
- Outdoor advertising, including billboards, advertisements on wall fences and motor vehicles  
- Point of sale materials  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 12 of 30 - Posters  
- Print advertisements  
- Promotional aids i ncluding those used for direct selling activities  
- Sales promotions  
- Telephone help lines  
- Television and radio commercials  
- Using social media platforms  
- Sports, art and other sponsorships  
 
1.3. PROHIBITIONS ON PROMOTION, ADVERTISEMENT AND MARKETING  
The applicants  shall adhere to the general requirements for promotion, advertisement  and 
marketing  of medicinal products, medical devices and medicated cosmetics. He/she shall not be 
allowed  to:  
a) Advertise  an unregistered medicinal product, medical devices and medicated  cosmetics.  
b) Advertise an unregistered indication of a registered medicinal products, medical devices 
and medicated cosmetics  
c) Make any false or misleading claims or representations.  
d) Make unsubstantiated claims.  
e) Target advertising material at children un der 1 8 years old.  
f) Make claims that mislead by emphasis, contrast or omission with regard to the safety, 
quality or efficacy of the therapeutic product.  
g) Make claims that give rise to any unrealistic expectations with regard to the effectiveness 
of the the rapeutic product.  
h) Make claims that cause fear, alarm or distress to the public.  
i) Encourage inappropriate or excessive use.  
j) Suggest guaranteed results without side effects.  
k) Encourage incorrect use or self -treatment of serious diseases and discourage from  
seeking a medical professional's advice.  
l) Falsely claim any endorsement by public authority.  
m) Include endorsements or recommendations by any healthcare professional or a person of 
celebrity, social or professional status.  
n) Use the names or logos of the Au thority and any of our professional groups.  
o) Offer refunds, in full or partial amounts, to users of the product.  
p) Sale, promote, distribute or market an unregistered medicinal product, medical devices 
and medicated cosmetics.   
q) Sale, promote, distribute or market medicinal product, medical devices and medicated 
cosmetics for non -authorized or not licensed establishments or personnel.  
r) Sale, promote, distribute or market medicinal product, medical devices and medicated 
cosmetics with disparaged references.   
s) Sale,  promote,  distribute or market medicinal product, medical devices and medicated 
cosmetics as a disguised promotion including but not limited to market research activities, post -Guidelines for control of promotion, advertis ement and marketing  
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Page 13 of 30 marketing surveillance or post authorization studies and clinical trials t argeting specific 
population group or compering their products against those of competitors.   
t) Received rewards, incentives, bonuses, or any other gifts entitled to or motivated by 
volume or quantities of sales of medicinal product, medical devices and medi cated cosmetics.  
 
1.4. GENERAL REQUIREMENTS FOR PROMOTION,  ADVERTISING AND 
MARKETING OF MEDICAL PRODUCTS  
 
The importance  of promotion, advertisement  and marketing  is not only informing, teaching or 
reminding the consumer of the existence of goods, it creates be nefits in consumer minds and 
secures product loyalty over substitutes and competitors.  
The following are general requirements for promotion, advertising and marketing of medical 
products:  
a) Language on promotional adverts should be among official languages used in Rwanda 
simple -to-understand, easily comprehensive and should not bring fear or distress to the public.  
b) The applicant should  apply for approval of promotional materials before importing them 
by submitting the mock -up or design to the Authority for r eview.  
 
c) The content of promotional materials must be designed in such a way that it is clear and 
that the material or message are in line with the product being promoted, advertised  and/or 
marketed . Presented  information  should be  factually correct and tho se facts should not be 
exaggerated in any way.  
d) Promotion  and advertisement  must be consistent with the approved product information. 
The promotion should be in line with conditions or illness for which it has been registered.  
e) Promotions should be done as p er the approved adverts. No changes can be made on the 
approved adverts without approval of the Authority.  
f) Public information about planned or ongoing trials in unauthorised indications/ uses is 
not acceptable.  
g) Promotion should be objective, without relyin g solely on the feelings or opinions of the 
advertiser and should refer to limitations that were relevant to the claims made for the product.  
h) Promotional claims presenting findings from studies as directly relevant to the clinical 
use of the product may al so be considered to exaggerate the benefits of the product, unless data 
are available to demonstrate the relevance and significance of the findings.  
i) Advertisements should be reliable, accurate, up -to-date, truthful, informative, balanced, 
and capable of su bstantiation and in good taste.  
j) Unsubstantiated claims of superiority over other brands  
k) Marketing communications should respect  human dignity.  
l) Marketing communications should not allow any form of discrimination that is based on 
race, et hnicity, national o rigin, age, gender, disability, sexual orientation, and religion.  
m) Marketing communications should not undermine  the products  of the competitors  
 
 Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Revision No.: 0  Effective Date:  23/07/2021    
Page 14 of 30 1.5. SPECIAL REQUIREMENTS  
 
1.5.1. Requirements for promotion, advertising and marketing of medicines  
 
1.5.1. 1 Con ventional and herbal human medicinal products  
 
a) Promotion to the public is not permitted for prescription medicines including  controlled 
medicines such as  narcotic and psychotropic medicines. However the Authority may approve 
promotion of prescription medic ines based on public interest according to Ministerial order No 
20/35 of 09/0 6/2015 determining unauthorized of controlled substances classified as narcotics 
drugs, pyschotropic substances and precursors . 
b) No Over The Counter (OTC) drug advertisement shall imply that the consumer is 
suffering or without treatment may suffer more severely from any illness, ailment or disease.  
c) It should be clearly indicated in the adverts that a medical consultation or medical 
diagnosis is necessary before self -treatment.  
d) Prom otion of any medicines directed to the general public which is likely to lead to the 
use of a  medicine is not allowed further reference in the Minist erial Instruction No 
20/4991/DGCS/2021 scpecified in article 3.  
e) Marketing of any medicines should not impl y the  pricing which is likely to lead to the use 
of a medicine.  
f) Advertising of medicinal products shall reflect an overall attitude of caution in relation to 
drug usage, with emphasis on rational use of medicines. It shall provide sufficient and balanced 
information to permit assessment of risk against the benefits.  
g) Promotion should not state or imply that a product is “safe”, is “100% safe” has “no side 
effects” or “ their use will not cause harm”. No advertisement shall contain words such as magic, 
miracl e or mystical; ‘drug of choice” exotic descriptions such as ‘super potency’ or such other 
words as to induce the daily and continuous use of the product.  
h) Promotional information available for self medication should not in any way put the 
vulnerable patient  groups at risk e.g use of medicines during pregnacy.  
i) No advertisement for drugs shall contain any price, offers of gifts, competition or refund 
of money to dissatified consumers.  
j) Advertisement for dietary supplements  should not imply as substitute for goo d nutrition 
or balanced diet .  
k) Promotion should be designed to ensure that prescribers are not misled by promotional 
claims in adverts which suggests that a particular medicine is safer than an alternative medicine 
unless this is supported by evidence.  
l) Promotional materials / adverts for dissemination to healthcare professionals only should 
be clearly stated in the materials or adverts “for healthcare professionals only”.  
m) Storage of medicines within view of public area (e.g. on display behind a pharmacy 
counter) should not be considered to be an advert provided that no product (s) is being promoted. 
This practice is acceptable as long as no attempt is made to make any product (s) more 
prominent than the others. However, for safety reasons it is considered go od practice for all 
POMs to remain out of the sight and reach of clients (i.e must be stored behind the sales counter 
and must not be available for self selection).  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 15 of 30 n) Only authorized, trained and/or licenced personel or estalishments are allowed to sale, 
promote, distribute and/or market registered conventional and herbal human medicinal products.  
 
1.5.1.2 Traditional medicines  
Traditional medicines allowed to be promoted for medicined purposes are only those which have 
been registered by the Authority. Speci fic requirements for promotional of these medicines are as 
follows:  
a) Promotion , advertisement and/or marketing  should be done only after  being issued with 
a written approval from Authority.  
b) Promotion should not contain an offer to treat any person, or to p rescribe any remedy for 
its treatment, or to give any advice in connections with the treatment of the diseases or 
conditions such as HIV/AIDS, Blindness; Cancer; Cataract; Drug addiction; Deafness;Diabetes; 
Epilepsy or fits; Hypertension; Insanity; Kidney disease; Leprosy; Mentrual disorders; Parlysis; 
Tuberculosis; Sexual Dysfunctions; Infertility; Importency; Frigidity; Conception and 
Pregnancy.  
c) Promotional claims such as “clinically proven” or “effective in” are not acceptable since 
the registration of t he products are principally based exclusively on long -standing use.  
d) Indications mus be true, valid and not misleading and should n ot lead to unsafe or 
inappropriate use of the product. Indication can be based on evidence of traditional use of 
substance or product,  
e) Promotional claims should be in line with the approved indications(s). Where the 
indication states “traditionally used for” or similar wording, this information must be stated in 
the promotion.  
f) Comparative marketing of products safety, efficacy an d affordability should not be 
mentioned . 
g) General health claims to illustrate the kind of efficacy claims may be used based on 
traditional/ long -standing use, with  documented evidence in the approved product information. 
Examples include; use as a liver to nic or to support liver function; for energy and general health 
maintenance; helps to maintain healthy vision; helps to support urinary tract function; promotes 
joint mobility; promotes vitality; promotes healthy hair &skin etc.  
h) Promotional claims that a p roduct is “organic”may only be made for products that have 
been registered as such.  
i) Promotion should not suggest that the safety and efficacy of the product is due to it being 
“natural”  
j) Promotion of traditional medicine should not contain a disclaimer stat ing that ‘efficacy’ 
of this product has been proven by Rwanda  FDA”.  
k) Promotional materials should contain a clear and legible invitation to “read carefully the 
instructions on the leaflet enclosed” in the package or on the label as the case may be.  
l) Only au thorized, trained and/or licenced personel or estalishments are allowed to sale, 
promote, distribute and/or market registered traditional medicines.  
 
 
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of medicines, medical devices and cosmetics in Rwanda  
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Page 16 of 30 1.5.2 Veterinary medicines  
 
Veterinary medicines are grouped as veterinary prescription medicines (POM -V) and veterinary 
non priscription medicines (Non POMV -V). Specific requirements for promotion of veterinary 
medicinary are as follows:  
a) POM -V should not be promoted, advertised and marketed to the general public.  
b) Promotional adverts for POM -V including ve terinary medicines containing psychotropic 
drugs or narcotics and all antimicrobial products may only be promoted or featured in public a 
cautions aimed to pharmacists and veterinary healthcare professionals which include veterinary, 
para professionals and  para professionals assistants.  
c) Promotion of antimicrobial products should not encourage unnecessary use of these 
medicines and all promotional adverts should contain a strap line indicating that the prescription 
and administration of the product should be  in accordance with the responsible use of 
antimicrobials.  
d) Marketing communications implying the comparative safety, efficacy and affordability of 
veterinary medicines should not be considered.  
e) Educational information designed to give a balanced overview o f the disease and all available 
treatments may be made available to the general public providing that products or brand names 
are not mentioned and all other promotion restrictions are adhered to.  
f) Storage of medicine within view of a public area ( e.g. on display behind a veterinary pharmacy 
counter) should not be considered to be an advert provided that no product (s) is being promoted. 
This practice is acceptable as long as no attempt is made to make any products more prominent 
than the others. However, f or safety reasons it is considered good practice for all POMs to 
remain out of the sight and reach of clients unless they are actually being used on the animal as 
part of the consultation.  
g) Promotion of any human medicine for administration to an animal is restricted even if there is no 
equivalent veterinary medicine.  
h) Only authorized, trained and/or licenced personel or estalishments are allowed to sale,  promote,  
distribute  and/or market registered veterinary medicines.  
 
1.5.3 Requirements for promotion , advertesing  and marketing of medical devices  
 
a) Promotion ,advertesement and marketing should not directly or indirectly suggest that the 
medical device can prevent, retard or reverse the physiological changes and degenerative 
conditions brought about by or a ssociated with ageing.  
b) Promotion advertesement and marketing should not make use of names, initials, logos and/ or 
trade marks of any company or institution without written permission from the concerned 
company or institution.  
c) Medical devices classified as  “Professional Use Only” should only be allowed to be promoted to 
healthcare professionals.  
d) Promotion  advertesement and marketing  should not give any implication that the medical advice 
can induce sexual virility or they are effective in treating sexual w eakness or sexual excess and 
conditions such as premature ejaculation and erectile dysfunction.  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 17 of 30 e) Promotion should not contain any claim, statement or implication that the medical device is 
infallible, unfailing, magical miraculous, or that it is a certain, guaranted; sure cure or compete 
cures  
f) Promotion ,adverti sement and marketing shall not expressly or implicity claim, indicate or 
suggest that the medical device will prevent, alleviate or cure any disease or conditions  
g) Promotion , adverti sement and marketin g to the general public should not directly or indirectly 
encourage indiscriminate, unneccesary or exclussive use of the medical device  
h) Testimonials featured in advertisements should reflect the typical experience of an average user 
of a medical device.  
i) Promotion ,advertesement and marketing to the public should not give the impression of advice 
or support from healthcare providers, i.e. visual and/or audio presentation of healthcare 
professionals.  
j) Only authorized, trained and/or licenced personel or estalis hments are allowed to sale, distributed 
or market registered medical devices.   
 
1.5.4  Requirements for promotion , advertising  and marketing of  regulated cosmetics  
 
a) No person or media shall promote, advertise  and/or market  any cosmetic in the print, elec tronic 
media including internet or by any means unless approved by the Authority.  
 
b) Advertisement and promotion material s, and marketing communications  that are subject to the 
guidelines include but limited to internet material, including press releases int ended for internet 
publication, publication, print advertisements, promotional aids including those used for direct 
selling activities, sales promotions, telephone help lines , television and radio commercials, sports 
art and other sponsorships  should ensur e the public health protection by complying with the 
requirements for promotion, advertising  and marketing  of regulated cosmetics . 
c) Advertisements shall not contain or refer to any testimonial or endorsement unless it is genuine 
and related to the personal  experience over a reasonable period or time of the person giving it.  
d) Advertisements , promotional claims and marketing communications  should contain information 
that is reliable, accurate, truthful, informative, balanced, up to date, and capable of substan tiation 
and in good taste. They should not contain misleading or unverifiable statements or omissions 
likely to induce unjustifiable use or give rise to undue risks.  
e) Advertisement  and promotion  should not induce fear on the part of the viewer or listener t hat he/ 
her is suffering and without the use of cosmetic product may worsen the condition  
f) Claims on cosmetics shall not imply  actions that are normally considered therapeutics in nature  
g) Marketing communications should not use comparative messages leading to the increase of sales 
of regulated cosmetics.  
h) Marketing communications should not imply the comparative product pricing that can lead to 
increased sales of promoted cosmetics.  
i) Promotional claims should take into consideration that cosmetics product typi cally have effects 
that are not permanent , and have to be used regularly to maintain their effects.  
j) Promotional claims can be softened or made less functional and more cosmotic in nature by the 
use of modifiers. For example: claim for removing all oil fro m the skin, can  be softened as Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 18 of 30 “helps to remove oil skin” or “reduces the shine of oily skin or suitable for oil skin” or “reduce 
the shine of oily skin” or “ makes your skin feel les oily”  
k) Only authorized, trained and/or licenced personel or estalishment s are allowed to sale, promote, 
distribute  and/ or market registered and regulated cosmetics.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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of medicines, medical devices and cosmetics in Rwanda  
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Page 19 of 30 2.0. TARGETED AUDIENCE IN PROMOTION, ADVERTISEMENT AND 
MARKETING  
2.1  Promotion, advertising and marketing Information to the Health care Workers  
 
A written  promotion material,  advertisement and marketing material for medicines should 
contain the foll owing elements : 
a) Trade/ Brand name or proprietary name,  
b) A quantitative listing of all active ingradient(s) using either approved generic n ame or 
international Non -proprietary Name (INN) of medicine  
c) An accurate statement of the dosage and strength  
d) Daily dose, frequency of administration  
e) Route or method of administration  
f) Major indication(s) for use;  
g) Adequate warnings(caution side effects, in teractions)  
h) Major precautions, contra -indications and warnings;  
Name and address of manufacturer or packaging company. If an imported  drug, the name and 
address of the local packing company or distributor must appear on the label in such a manner as 
to identify the relationship between the packing company or distributor with such drug.  
 
2.2 Promotion, advertisement  and marketing  to the general public  
 
1)  Promotion , advertisement  and marketing targeted to the general public must contain the 
following:  
a) The gener ic name of a drug, brand name/trade name of the drug  
b) name(s) of the active ingredient(s) using international non -proprietary names (INN)  
c) approved major indication(s) for use  
d) major precautions, contra -indications and warnings  
e) name and address of manufactu rer  
f) dosage regimen  
g) phrase “If symptoms persist seek medical advice” or a similar meaning phrase  
 
2) Promotion, advertisement and marketing to the general public shall take into 
consideration the following:  
a) Help people to make an informed decision on the cho ice and use of drugs determined to 
be legally available without a prescription.  
b) Take account of people’s legitimate desire for information regarding their health.  
c) Not take undue advantage of people’s concern for their health  
 
2.3 Activities that do not form  promotion , advertisement and marketing  
 
The following activities do not form promotion , advertisement and marketing practices:  
a) replies made in response to individual enquiries from healthcare workers or employees in 
response to specific communications fro m them whether of enquiry or comment, including 
letters published in professional journals, but only if they relate solely to the subject matter of the Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 20 of 30 letter or enquiry, are accurate and do not mislead and are not promotional in nature,  
b) factual, accurate,  informative announcements and reference material concerning licensed 
medicines and relating, for example, to pack changes (color, design), adverse reaction warnings, 
trade catalogues(for medical devices only) and price lists, provided they include no prod uct 
claims.  
c) Statements relating to human health or diseases provided there is no reference, either 
direct or indirect, to specific products.  
d) An advertisement that over -dramatizes any symptoms by way of drawing a picture  Guidelines for control of promotion, advertis ement and marketing  
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Page 21 of 30  
3.0. MODE OF PROMOTION , ADVERTISEMENT AND MARKETING  
 
Any activity undertaken in the different methods provided hereunder shall constitue the 
medicines, medical devices and cosmetics promotion. Therefore it shall be used after approval of 
Authority:  
 
a) Still 
 
Includes any promotional adverts in p rint media such as magazines, news papers, journals, 
diaries, flyers, brochures, billboards, posters, branding on vehicles, buildings, benches and other 
print publications. A promotional aid (note pads, calendars and other such items) shall be limited 
to bear names of products currently registered in Rwanda.  
 
b) Light and sound  
 
Includes any promotional adverts with light and sound effects, such as broadcast over radio, 
radio cassettes or any  audio, television, cinema advertisements and videos.  
 
c) web based  
 
Includes any promotional adverts on websites. Promotion of prescription medicines are 
acceptable only on websites whose nature and content are directed to healthcare professionals. 
Sections of a website aimed at airing such adverts should ideally be access r estricted. Where an 
information is presented as a linked page on an internet website, the link should be clearly 
visible.  
 
d) Sales promotion  
This is any activity with the purpose of introducing, publicising or promoting the sale of a 
product   
 
e) Promotion , adv ertesing  and marketing  Samples  
 
  There  should be no sale or supply of samples of medicines or medical devices to any 
member of the public for promotion and marketing purposes.  
  Samples of medicines (except for traditional medicines) and medical devices may only be 
supplied as free samples to qualified prescribers or pharmacists for the purpose of promotion.  
  The free samples provided by medical representatives should be labelled “physician sample 
not for sale”.  
  There are no restrictions applicable to co smetics with regard to provision of this section.  
 
f) Symposia and other meetings  
 
All meetings including workshops, conferences, seminars symposia and exhibitions that are 
organized or sponsored by any company or under its control targeting the healthcare 
professionals, or any other person for the purpose of promoting  and/or marketing  medicines, 
medical devices or cosmetics or its launching should first obtain approval from Authority. The 
following procedures should be made when filling in applications for pr omotional meetings :  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 22 of 30  
 Applications should be made by filling in the application form as prescribed in Annex Ӏ and 
submitting to the Authority not less than 2 weeks before the meeting.  
 The application should be accompanied by the proof of payment for fees p rescribed in 
regulations No CBD/TRG/004 related to regulatory service tariff/fees and fines; and the samples 
of all materials or products to be used in the meeting for promotional activities.  
 Presentation at symposia or seminars shall be factual, accurate,  without omission and not 
biased towards any particular company’s products.  
 Sales of medicines during such meetings or trade where regulated products is exhibited is 
prohibited.  
 
 
g) Promotion and marketing in public health programme/campaigns  
 
 Campaigns rel ating to medicines, medical devices or cosmetics that are directed to the 
general public with a view of providing information, promoting awareness or education about a 
particular condition or disease are encouraged. But, care must be taken to ensure that t he 
information provided is correct as per this guideline requirements.  
 Public health programmes such as government controlled programmes (vaccination 
&malaria campaigns etc) that have been approved by the responsible ministry are required to 
obtain an appr oval letter from the Regulatory Authority . 
 
3.1 Requirements for promotion  and advertisement   applications  
 
a) Application letter addressed to the Authority  
b) Applications for approval of promotional materials for medicines, medical devices , 
cosmetics shall be  made by submitting a dully filled application form attached as Annex Ⅲ 
accompanied with prescribed information as detailed in these guidelines.  
c) Samples of Promotional materials to be aired in one CD -R copy or printed scripts of the 
final adverts with respect to media to be used. Note that : documented such as video clips sho uld 
be viewable via Windows Media Player.  
d) Proof of sciencific evidence for claimed information  
e) Samples (if applicable) of the final package and ready for the market  
f) Applications shall be accompanied by the following:  
 Proof of up -to-date registration of t he company that wishes to advertise;  
 Proof of up -to-date registration of the product to be advertised;  
g) Certified copies of degrees of qualified personnel in areas of medicine who will promote 
and advertese the products or who approved the message at compan y level.  
h) The proof of payment of prescribed fees under Regulations no CBD/TRG/004 related to 
regulatory service tariff/fees and fines may be paid directly to the Authority  
 
 
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Page 23 of 30 4.0. STAKEHOLDERS  RESPONSIBILITIES  
 
In order to effectively execute its functions in cluding management and control of product 
promotions , advertisement and/ or marketing, the A uthority has to work in close cooperation  and 
collaboration with all stakeholders. The various roles and responsiblities of different Authority 
stakeholders in line  with promotion of regulated products as follows:  
 
4.1 Medical and pharmaceutical representatives  
 
All dealers of medicinal products, medical devices and medicated cosmetics include 
manufacturers, importers and distributors, suppliers, wholesalers and reta ilers. Generally, dealers 
are responsible to ensure that their products comply with quality, safety and  efficacy standards 
and are officially authorised by the Authority to be marketed in Rwanda before subjecting them 
to any promotional activity. The manu facturers and distributors should submit applications for 
authorization of their medical representatives to the Authority.  
 
This will evaluate the applications and issue a permit for medical representatives once the 
prerequisite conditions have been met. The manufacturer and/or distributor will be responsible 
for the statements and activities of their medical representatives. Any change of employment by 
a medical representative must be reported to the Authority, and a new permit issued with respect 
to the new employer.  
 
4.2 Qualification of medical representatives  
The medical representative shall possess minimum qualification of Diploma (A1 or A2) in 
medical science (Pharmaceutical, Medicine and Surgery, Veterinary medicine, Nursing and 
Midwife, Dental ther apy/Surgery, Clinical medicine, Anaesthesia, Ophthalmology , Laboratory, 
Bio-Medical Engineering, Clinical psychology, Public health,…) or life sciences (Bio -
Technology, Biology , Food Science, Chemistry, Microbiology,…) veterinary or public health 
from reco gnized institution with relevant experience and/or trainings in matters related to 
medicines.  
 
In preparing promotional adverts, dealers are obliged to ensure that the information provided 
about their respective products are correct and presented objectiv ely to encourage their rational 
use. The information provided must comply with the Authority Regulations on product 
promotions. Dealers are also responsible to report to the Authority any contraventions and/or all 
defaulters of the laws and regulations and  be ready to collaborate and cooperate with Authority 
in sharing information relating to quality, safety and efficacy of medicines,  medicinal devices 
and cosmetics.  
 
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of medicines, medical devices and cosmetics in Rwanda  
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Page 24 of 30 4.3 Local Government Authorities and Law enforcers  
Local Government Authorities and Law enforcers play the roles and responsibilities to enforce 
the laws and to sensitize their employees to voluntarily enforce the services and its regulations 
including one for control of medicines, medical devices and cosmetics promotion in this case.  
4.4  He althcare Professionals  
Healthcare professionals are among important players in medicines, medical devices and 
cosmetics promotions. They play two counter roles; promoters as well as persons to whom 
promotions are directed. Therefore healthcare professional s are responsible to:  
a) Lawfully participate in product as well as health promotion campaigns to  not only  influence 
the product rational use  but also  and raise awareness of heath issues and disease prevention.  
b) Report to the Authority any contraventions and/o r all defauters of the laws especially 
dealers who deliberately give out exaggerated or misleading information about quality, safety 
and efficacy of medicines, medical devices and cosmetics.  
4.5  Media  
Media plays a great role in emphasizing voluntary comp liance to the existing laws and 
regulations th rough public education. The role of media in advocating these requirements for 
product promotion is :  
a) To convey the right information about regulated products and particularly the DOs and 
DON’Ts in terms of pro moting , advertising  and marketing  medicines, medical devices and 
cosmetics and educate the public accordingly;  
b) To voluntarly comply with the requirements of the Authority, and respective regulations and 
guidelines for control of product promotion;  
c) To repor t to the Authority any contraventions and/or all defaulters of the laws especially 
dealers who deliberately give out exaggerations or misleading information about quality, safety 
and efficacy of medicines, medical devices and cosmetics;  
d) To reject airing an y promotional adverts from dealers which do not have approval from the 
Authority;  
e) To give constructive comments and recommendations on how to effectively and efficiently 
control regulated product promotions;  
4.6 General Public  
All promotions, advertisement s and marketing prepared by dealers are made in a way to 
pursuade community members to make choice of buying/ using them. Hence, the general public 
is a very important category of stakeholders in ensuring that dealers of medicines, medical 
devices and cosm etics comply to laws and promotion regulations.  
The general public is thus obliged to:  
a) Fetch the right/ correct information from Authority on the quality safety and efficacy of 
medicines, medical devices and cosmetics.  
b) Require the Authority to always prov ide updated information regulated products.  
c) Report to the Authority any promotion, advertisement or marketing which has been 
forbidden and/or whose information is suspected to be exaggerated or misleading information 
about quality, safety and efficacy of m edicines, medical devices and cosmetics.  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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5.0. COMPLAINTS REGARDING PROMOTED , ADVIRTISED AND MARKETED 
PRODUCTS  
 
The Authority is particularly keen to receive complaints where promotional adverts may have an 
adverse impact to public health. It will investigate complaints received from anyone who has 
seen promotion advert for a medicine, medical devices or cosmetics that in his/her view is 
misleading or otherwise fails to comply with the legal requirements.  
 
The following is the procedure for logging complaints regarding promoted products:  
a) Complaints on advertised, promoted or marketed products identified under these guidelines 
shall can be made to the Authority in the prescribed form attached as Annex ӀӀ. The form can be 
obtained from Rwanda FDA headquaters or t hrough the Rwanda FDA website  
b) Complaint forms that have not been completed and signed will not be processed.  
c) A submitted complaint should have detailed of when and where the promotion advert was 
seen and if possible a copy of the advertisement, together wi th detailed of the concerns about the 
advertisement should be attached.  
d) The Authority will complete the investigation within 30 days. This time may be extended 
when statutory action is taken. Should the investigation take longer, the complainant will be 
updated on progress.  
e) When closing the case the Authority will provide the complainant with details of the 
outcome  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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of medicines, medical devices and cosmetics in Rwanda  
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6.0 ENDORSEMENT OF THE GUIDELINES  
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Annex 1: Application Form  
 
1. Applicant Particulars  
Name of  applicant:..................................................................   ............................  
Address: .................................................................................................................... .... 
Contact person: . ............................................E -mail: ....................................................  
Telephone Number: ........................................ Fax Number: ..................................  
 
2. Type of meetings (tick)  
[        ] Workshop  
[        ] Conferences  
[        ] Seminar  
[        ] Symposia  
[        ] Exhibitions  
 
3. Responsible Person Information  
3.1 Name of person / company responsible for event...................................................................  
 
3.2  Address ............... ....................................................................................................................  
 
3.3 Telephone Number Fax (if applicable) Email (if application) 
...................................................  
 
4. Location Information  
4.1 Name  of premises where event is to be held ...................................................................  
 
4.2 Plot No./ Street/ Municipal/ Town/ City/ Region .............................................................  
 
5. Dates and Times of Event  
Start Date/ Time ...............................................................................................  
 
End Date/ Time  
(a.m / p.m.) Room Name / Area / Location ........................................................  
 
6. Product (s) promoted (attach list)  
 
Prod uct category ( please tick the appropriate box ) 
Human Medicine [   ] Veterinary Medicine [     ]  Herbal Medicines [  ]  Traditional Medicine [  
] Medical Device [  ]  Cosmetic [  ] other [  ]splease specify..............................................  
 
Product Name(s): .............................................................................................................. .. 
Registration number: ........................................................................................................ . 
Name of registration: ........................................................................................................ . 
Type of Advertisement: ......................................................................................................  
Type of material: (please tick the appropriate box)  
Poster [  ]  Leaflet[  ]  Cinema [  ]  Outdoor/ billboard [  ]  In /On Public Transport[  ]  Guidelines for control of promotion, advertis ement and marketing  
of medicines, medical devices and cosmetics in Rwanda  
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Page 28 of 30 Magazines/ Newspaper [  ]  Litterature [  ]  Radio [  ]  Television [  ]  
Other  [  ] please specify .............. ..............................................................................  
 
This form shall be accompanied by:  
NB: Please tick or mark X on Checklist  
 
[   ]  A copy of the proposed advert ( Script, Audio tape, CD, VCD, DVD, Video casette.)  
[   ]  Curr ent indications of use as indicated on Certificate of Registration (where applicable)  
[   ]  Copy of any research/ surveys/ data metioned in advertisement  
(Note - further evidence to be provided if requested).  
[   ]  Copy of previous approval ( if the adve rt is a reminder)  
[   ]  Copy of approval for the use of a restricted / prohibited claim (if applicable).  
[   ]  Application fee.  
 
Applicant Declaration  
 
I, .................................................................................................. ........declare that the information 
contained within this apllication is true and correct.  
Signed: .............................  
Date: ................................  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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    Annex 2:   APPLICATION FOR PERMIT TO CONDUCT PROMOTI ON MEETING  
(All information supplied in this form must be typed or written in block capital letters.)  
 
3. Applicant Particulars  
Name of applicant:..................................................................   ....................................  
Addres s: ........................................................................................................................  
Contact person: .............................................E -mail: 
....................................................  
Telephone Number: .......................................  
 
2. Type of meetings (tick)  
[        ] Workshop  
[        ] Conferences  
[        ] Seminar  
[        ] Symposia  
[        ] Exhibitions  
 
7. Responsible Person I nformation  
3.4 Name of person / company responsible for 
event...................................................................  
3.5  Address 
............................................................................................................................. ...... 
3.6 Telephone Number Fax (if applicable) Email (i f application) 
...................................................  
8. Location Information  
8.1 Name of premises where event is to be held 
...................................................................  
8.2 Plot No./ Street/ Municipal/ Town/ City/ Region 
......... ....................................................  
9. Dates and Times of Event  
Start Date/ Time 
......................................................................................................................  
 
End Date/ Time  
(a.m / p.m.) Room Name / A rea / Location 
............................................................................  
10. Product (s) promoted (attach list)  
Signed: .............................  
Date: ................................  
 
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Annex 3: Complaint form  
 
1.0 COMPLAINANT / REPOR TER DETAILS 
(optional)   
1.1 Name of the person / company / institution   
1.2  Address   
1.3 Email   
1.4 Telephone Number   
2.0    PRODUCT DETAILS   
Product Type: (tick)   
2.1  Human medicine   
2.2   Veterinary Medicine   
2.3 Herbal Medicine   
2.4 Traditi onal Medicine   
2.5 Medical  Device   
2.6 Cosmetic   
2.7 Others (please specify)   
3.0 ADVERTISEMENT TYPE   
3.1  Magazine/ Newspaper   
3.2  Radio   
3.3  Cinema   
3.4  Outdoor/ billboard/ shopping mall   
3.5  Television   
3.6  In/ on  public transport   
3.7  Others - please specify   
4.0 SUPPORTING INFORMATION / 
DOCUMENTS   
4.1 Copy of the advertisement (if applicable)   
4.2 When and where it appeared   
4.3 Reasons for your concern over the advertising 
e.g. what you consider is wrong with it.   
4.4 Advertisi ng complaints related to product 
unauthorised (Not registered) by Authority  Yes:.......................  
No:..........................  
4.5     A copy of any information regarding any 
communication that you have been involved in with 
the advertiser prior to  complaining to the Authority  Yes:..........................  
 
 
No:.............................  
Signature of complainant:  
....................................................................  Date :  
............................