Medicinal Products (Advertising) Regulations, 2005

L.N. 380 of 2005

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Medicinal Products (Advertising) Regulations, 2005

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, the Elderly and Community Care has

made the following regulations>-

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

(Advertising) Regulations, 2005

(2) These regulations shall come into force on the 30 th

October, 2005.

(3) The scope of these regulations is to transpose Directive

2004#27#EC.

In these regulations, unless the context otherwise requires>

“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<

“medicine” means a medicinal product<

“starter packs” means small packs for which a marketing

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 Advertising

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 traveling and accommodation expenses in

connection therewith.

(3)

The provisions of subregulation (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) information relating to human health or diseases,

provided that there is no reference, even indirect, to medicinal

products.

The advertising of a medicinal product shall –

(a) encourage the rational use of the medicinal product, by

presenting it objectively and without exaggerating its properties<

(b) comply with the particulars listed in the summary of

product characteristics of the medicinal product< and

(c)

not be misleading.

(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<

(b) contain substances defined as psychotropic or narcotic

under the First Schedule to the Dangerous Drugs Ordinance and

the Third Schedule to the Medical and Kindred Professions

Ordinance.

(3) No medicinal products may be distributed directly to

the public by the industry for promotional purposes>

Provided that the provisions of sub-regulation (2) shall not

apply to vaccination campaigns when these are carried out by industry

after having obtained the approval of the Licensing Authority>

Provided further that the prohibition referred to in sub-

regulation (2) shall apply without prejudice to Article 14 of Directive

89#552#EEC.

(4) Medicinal products may be advertised to the general

public which, by virtue of their composition and purpose, are intended

and designed for use with the advice of the pharmacist, if necessary,

but without the intervention of a medical practitioner for diagnostic

purposes or for the prescription or monitoring of treatment.

(5) The Licensing Authority shall be entitled to ban

advertising to the general public of medicinal products the cost of which

may be reimbursed.

(1) Without prejudice to regulation 5, all advertising to the Method of

advertising.

general public of a medicinal product shall>

(a) be set out in such a way that it is 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.

(2) The advertising of a medicinal product to the general

public may, notwithstanding sub-regulation (1) hereof, include only

the name of the medicinal product or its international non-proprietary

name, where this exists, or the trademark if it is intended solely as a

reminder and takes place by means of the use of promotional aids.

The advertising of a medicinal product to the general public Excluded material

in advertising.

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<

(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.

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) the 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 marketing

authorization holder<

(b) the supply classification of the medicinal product>

The advertising of a medicinal product to persons qualified

to prescribe or supply such products may, notwithstanding paragraph

(a) and (b) hereof, include only the name of the medicinal product or its

international non-proprietary name, where this exists, or the trademark

if it is intended solely as a reminder and takes place by means of the use

of promotional aids.

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

information on

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

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 sub-regulation (1) hereof shall be accurate, up-to-date,

verifiable and sufficiently complete to enable the recipient to form his

or her own opinion of 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), shall be faithfully

reproduced and the precise sources indicated.

(1) Where medicinal products are being promoted to No gifts, or

persons qualified to prescribe or supply them, no gifts, pecuniary pecuniary

advantages or

advantages or benefits in kind may be supplied, offered or promised to benefits in kind.

such persons unless they are inexpensive and relevant to the practice of

medicine or pharmacy>

Provided that this shall not prevent hospitality being offered,

directly or indirectly, at events for purely professional and scientific

purposes< such hospitality shall always be strictly limited to the main

scientific objective of the event< it must not be extended to persons

other than health-care professionals.

(2) Hospitality at sales promotion events shall always be

strictly limited to their main purpose and must not be extended to persons

other than health-care 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) hereof>

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 no larger than 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<

(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 to the Dangerous Drugs Ordinance and the Third

Schedule to the Medical and Kindred Professions Ordinance, may

be supplied.

(2) Without prejudice to sub-regulation (1) hereof, 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 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, Marketing

authorisation

within his undertaking, a scientific service in charge of information holder.

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 (2) and (3)<

(d) supply the advertising 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.

(3) It shall be lawful for the market authorization holder

and one or more companies nominated by him to co-promote a medicinal

product.

Advertising of homeopathic medicinal products referred to

in regulation 10 (3) of the Medicines (Marketing Authorisation)

Regulations, 2005 shall be subject to the provisions of these regulations

except regulation 5(1), provided that only the information specified in

regulation 13(2) of the Medicinal Products (Labelling and Packaging)

Regulations, 2005 may be used in the advertising of such medicinal

products.

(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.

The Medicinal Products (Advertising) Regulations, 2003 are

hereby repealed.

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