Medicinal Products (Advertising) Regulations, 2003

L.N. 400 of 2003

MEDICINES ACT, 2003

(ACT NO. III of 2003)

Medicinal Products (Advertising) Regulations, 2003

IN exercise of the powers conferred by articles 31 and 106 of the

Medicines Act, 2003, the Minister of Health, has made the following

regulations>-

(1) The title of these regulations is the Medicinal Products Citation and

commencement

(Advertising) Regulations, 2003.

(2) These regulations shall come into force on the 1st May,

2004. In these regulations, unless the context otherwise requires>

Interpretation.

“the Act” means the Medicines Act<

“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<

(1) Advertising of medicinal products shall include any 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 products and in particular

payment of their travelling and accommodation expenses in

connection therewith.

(3) The provisions of sub-regulation (1) hereof 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

(d) statements relating to human health or diseases, provided

there is no reference, either direct or indirect, to medicinal products.

The advertising of a medicinal product>

Advertising quality.

(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.

(1) It shall not be lawful to advertise medicinal products for Advertising criteria

which no marketing authorisation has been granted<

(2) (a) It shall not be lawful to advertise to the general

public medicinal products which 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

(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 Cap. 31.

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 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 sub-regulations (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.

Without prejudice to regulation 5 of these regulations, 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.

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 sub-regulations (1) and (2)

of regulation 5 hereof<

(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,

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.

Any advertising of a medicinal product to persons qualified Advertising material

to persons qualified

to prescribe or supply such products shall include>

to prescribe

(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.

(1) Any documentation relating to a medicinal product which Minimum

is transmitted as part of the promotion of that product to persons qualified information

documents.

to prescribe or supply it shall include, as a minimum, the particulars

listed in regulation 8 hereof 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 sub-regulation (1) of this regulation, 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 sub-regulation (1) of these regulations,

shall be faithfully reproduced and the precise sources indicated.

(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 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

sub-regulation (1) or contrary to sub-regulation (2) of this regulation>

Provided that existing measures or trade practices relating

to prices, profit margins and discounts shall not be affected.

(1) Free samples shall be provided on an exceptional basis

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<

(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 sub-regulation (1) of this regulation,

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.

(1) Medical sales representatives shall be given adequate Sales

training by the firm which employs them and shall have sufficient representatives.

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 together

with details of the price .

(3) Medical sales representatives shall transmit to the

scientific service referred to in regulation 13 hereof 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.

(1) The marketing authorisation holder shall establish, Detentur ta’

awtorizzazzjoni

within his undertaking, a scientific service in charge of information g[all-bejg[.

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 hereof,

(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

(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.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press