MEDICINAL PRODUCTS (ADVERTISING) ġ S.L.458.32 1
SUBSIDIARY LEGISLATION 458.32
MEDICINAL PRODUCTS (ADVERTISING) 
REGULATIONS
1st May, 2004
LEGAL NOTICE 400 of 2003.
Citation.
(Advertising) Regulations.
Interpretation.
Cap. 458.
''the advertising committee'' means the advertising committee for
medicinal products working within the Authority;
''the Authority'' means the Medicines Authority established under
article 4 of the Act;
''medicinal products'' means medicinals for human use;
''starter packs'' means small packs for which a market
authorisation has been granted, designed to provide sufficient
medicine for a prescriber to initiate treatment in such
circumstances where there might be undesirable or unavoidable
delay in having a prescription dispensed, where immediate
commencement of treatment is necessary, or where the prescriber
feels that the use of such presentation is indicated in the interests of
the patient;
Advertising.
form of door-to-door information, canvassing activity or
inducement designed to promote through any means or media the
prescription, supply, sale or consumption of medicinal products.
(2) Such advertising shall in particular include:
( a ) the advertising of medicinal products to the general
public;
( b ) advertising of medicinal products to persons qualified
to prescribe or supply them;
( c ) visits by medical sales representatives to persons
qualified to prescribe or supply medicinal products;
( d ) the supply of samples;
( e ) the provision of inducements to prescribe or supply
medicinal products by the gift, offer or promise of any
benefit or bonus, whether in money or in kind, except
when their intrinsic value is minimal;
( f ) sponsorship of promotional meetings attended by
persons qualified to prescribe or supply medicinal
products; and
( g ) sponsorship of scientific congresses attended by
persons qualified to prescribe or supply medicinal
2 ġ S.L.458.32 MEDICINAL PRODUCTS (ADVERTISING)
products and in particular payment of their travelling
and accommodation expenses in connection therewith.
(3) The provisions of subregulation (1) shall not include:
( a ) the labelling and the accompanying package leaflets,
which are subject to the provisions of the Act or any
regulations made thereunder;
( b ) correspondence, possibly accompanied by material of
a non-promotional nature, needed to answer a specific
question about a particular medicinal product;
( c ) factual, informative announcements and reference
material relating to such matters as pack changes,
adverse-reaction warnings as part of general drug
precautions, trade catalogues and price lists, provided
they include no product claims;
( d ) statements relating to human health or diseases,
provided there is no reference, either direct or indirect,
to medicinal products.
Advertising 
quality.
4. The advertising of a medicinal product:
( a ) shall encourage the rational use of the medicinal
product, by presenting it objectively and without
exaggerating its properties;
( b ) shall comply with the particulars listed in the summary
of product characteristics of the medicinal product;
( c ) shall not be misleading.
Advertising criteria 5. (1) It shall not be lawful to advertise medicinal products
for which no marketing authorisation has been granted.
(2) It shall not be lawful to advertise to the general public
medicinal products which -
( a ) are available on medical prescription only, in
accordance with the classification of medicinal
products as defined in the Act or any regulations made
thereunder; or
Cap. 101.
Cap. 31.
( b ) contain narcotic drugs or psychotropic substances, as
defined under the First Schedule of the Dangerous
Drugs Ordinance and the Third Schedule of the
Medical and Kindred Professions Ordinance.
(3) It shall not be lawful to mention in advertising to the
general public therapeutic indications such as:
( a ) tuberculosis;
( b ) sexually transmitted diseases;
( c ) other serious infectious diseases;
( d ) cancer and other tumoral diseases;
( e ) chronic insommnia;
( f ) diabetes and other metabolic diseases.
(4) No medicinal products may be distributed directly to the
MEDICINAL PRODUCTS (ADVERTISING) ġ S.L.458.32 3
public by the industry for promotional purposes unless such
distribution is authorised by the Licensing Authority in special
cases and for specific purposes:
Provided that the provisions of subregulations (1) and (2)
shall not apply to vaccination campaigns when these are carried out
by industry after having obtained the approval of the Licensing
Authority.
(5) Medicinal products may be advertised to the general public
which, by virtue of their composition and purpose, are intended and
designed for use without the intervention of a medical practitioner
for diagnostic purposes or for the prescription or monitoring of
treatment, with the advice of the pharmacist, if necessary.
Method of 
advertising.
6. Without prejudice to regulation 5, all advertising to the
general public of a medicinal product shall:
( a ) be set out in such a way to be clear that the message is
an advertisement and that the product is clearly
identified as a medicinal product;
( b ) include the following minimum information:
(i) the name of the medicinal product, as well as the
common name if the medicinal product contains
only one active substance;
(ii) the information necessary for the correct use of
the medicinal product; and
(iii) an express, legible invitation to read carefully
the instructions on the package leaflet or on the
outer packaging, as the case may be.
Excluded material 
in advertising.
7. The advertising of a medicinal product to the general
public shall not contain any material which:
( a ) gives the impression that a medical consultation or
surgical operation is unnecessary, in particular by
offering a diagnosis or by suggesting treatment by
mail, internet or any other means;
( b ) suggests that the effects of taking the medicine are
guaranteed, are unaccompanied by adverse reactions
or are better than, or equivalent to, those of another
treatment or medicinal product;
( c ) suggests that the health of the subject can be enhanced
by taking the medicine;
( d ) suggests that the health of the subject could be affected
by not taking the medicine provided that this shall not
apply to the vaccination campaigns referred to in
regulation 5(1) and (2);
( e ) is directed exclusively or principally at children;
( f ) refers to a recommendation by scientists, health
professionals or persons who are neither of the
foregoing but who, because of their celebrity, could
encourage the consumption of medicinal products;
( g ) suggests that the medicinal product is a foodstuff,
4 ġ S.L.458.32 MEDICINAL PRODUCTS (ADVERTISING)
cosmetic or other consumer product;
( h ) suggests that the safety or efficacy of the medicinal
product is due to the fact that it is natural;
( i ) could, by a description or detailed representation of a
case history, lead to erroneous self-diagnosis;
( j ) refers, in improper, alarming or misleading terms, to
claims of recovery;
( k ) uses, in improper, alarming or misleading terms,
pictorial representations of changes in the human body
caused by disease or injury, or of the action of a
medicinal product on the human body or parts thereof;
( l ) mentions that the medicinal product has been granted a
marketing authorisation.
Advertising 
material to persons 
qualified to 
prescribe.
8. Any advertising of a medicinal product to persons qualified
to prescribe or supply such products shall include:
( a ) essential information compatible with the summary of
product characteristics which shall include -
(i) the trade name;
(ii) a list of active ingredients;
(iii) a pharmaceutical form;
(iv) major indications for use;
(v) the dosage and method of use;
(vi) side effects, warnings, precautions and
contraindications;
(vii) the name and address of the market authorisation
holder; and
( b ) the supply classification of the medicinal product.
Minimum 
information on 
documents.
9. (1) Any documentation relating to a medicinal product
which is transmitted as part of the promotion of that product to
persons qualified to prescribe or supply it shall include, as a
minimum, the particulars listed in regulation 8 and shall state the
date on which it was drawn up or last revised.
(2) All the information contained in the documentation referred
to in subregulation (1) shall be accurate, up-to-date, verifiable and
sufficiently complete to enable the recipient to understand the
therapeutic value of the medicinal product concerned.
(3) Quotations as well as tables and other illustrative matter
taken from medical journals or other scientific works for use in the
documentation referred to in subregulation (1), shall be faithfully
reproduced and the precise sources indicated.
No gifts, or 
pecuniary 
advantages or 
benefits in kind.
10. (1) Where medicinal products are being promoted to
persons qualified to prescribe or supply them, no gifts, pecuniary
advantages or benefits in kind may be supplied, offered or
promised to such persons unless they are inexpensive and relevant
to the practice of medicine or pharmacy.
(2) Hospitality at sales promotion and hospitality being offered
MEDICINAL PRODUCTS (ADVERTISING) ġ S.L.458.32 5
at events for purely professional and scientific purposes, shall
always be reasonable in level and secondary to the main purpose of
the meeting and must not be extended to other than health
professionals.
(3) Persons qualified to prescribe or supply medicinal products
shall not solicit or accept any inducement prohibited under
subregulation (1) or contrary to subregulation (2):
Provided that existing measures or trade practices relating
to prices, profit margins and discounts shall not be affected.
Free samples.
only to persons qualified to prescribe them and on the following
conditions:
( a ) the number of samples for each medicinal product
each year on prescription shall be limited;
( b ) any supply of samples shall be in response to a written
request, to be signed and dated, from the prescribing
agent;
( c ) persons supplying samples shall maintain an adequate
system of control and accountability;
( d ) each sample shall be identical with the smallest
presentation on the market;
( e ) each sample shall be marked ''free medical sample -
not for sale'' or shall show some other wording having
the same meaning. Such marking shall be legible and
indelible;
( f ) each sample shall be accompanied by a copy of the
summary of product characteristics;
Cap. 101.
Cap. 31.
( g ) no samples of medicinal products containing
psychotropic or narcotic substances as defined under
the First Schedule of the Dangerous Drugs Ordinance
and the Third Schedule of the Medical and Kindred
Professions Ordinance, may be supplied.
(2) Without prejudice to subregulation (1), samples of
medicinal products classified in terms of article 29(2) of the Act as
being medicinal products that can only be prescribed by a specific
class of prescriber shall only be distributed to such class of
prescribers.
(3) Starter packs shall not be regarded as samples and shall not
be labelled as such.
Sales 
representatives.
12. (1) Medical sales representatives shall be given adequate
training by the firm which employs them and shall have sufficient
scientific knowledge to be able to provide information which is
precise and as complete as possible about the medicinal products
which they promote.
(2) During each visit, medical sales representatives shall give
the persons visited, or have available for them, summaries of the
product characteristics of each medicinal product they present
6 ġ S.L.458.32 MEDICINAL PRODUCTS (ADVERTISING)
together with details of the price.
(3) Medical sales representatives shall transmit to the scientific
service referred to in regulation 13 any information about the use of
the medicinal products they advertise, with particular reference to
any adverse reactions reported to them by the persons they visit.
Marketing 
authorisattion 
holder.
13. (1) The marketing authorisation holder shall establish,
within his undertaking, a scientific service in charge of information
about the medicinal products, which he places on the market.
(2) The marketing authorisation holder shall:
( a ) keep available for, or communicate to, the advertising
committee for medicinal products, a sample of all
advertisements emanating from his undertaking
together with a statement indicating the persons to
whom it is addressed, the method of dissemination and
the date of first dissemination,
( b ) ensure that advertising of medicinal products by his
undertaking conforms to the requirements of these
regulations,
( c ) verify that medical sales representatives employed by
his undertaking have been adequately trained and that
they fulfill the obligations imposed upon them by
regulation 12,
( d ) supply the advertisng committee with the information
and assistance it requires to carry out its
responsibilities,
( e ) ensure that the decisions taken and conditions imposed
by the advertising committee are immediately and
fully complied with.
Advertising 
committee.
14. (1) There shall be established within the Authority an
advertising committee made up of appropriately qualified staff as
determined by the Chief Executive Officer of the Authority.
(2) The advertising committee shall be responsible for
advertising issues which include:
( a ) the offering of advice and information on advertising
issues;
( b ) the issuing of conditions and guidelines on
advertising;
( c ) the monitoring of advertisements of medicinal
products;
( d ) the investigation of cases suspected of breaching these
regulations or any guidelines as may be issued by the
Authority, including complaints made by the public.
