MEDICINAL PRODUCTS (ADVERTISING) REGULATIONS (advertising)

SUBSIDIARY LEGISLATION 458.32

MEDICINAL PRODUCTS (ADVERTISING)

REGULATIONS

30th October, 2005

LEGAL NOTICE 380 of 2005.

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

(Advertising) Regulations.

(2) 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

f o r m o f d o o r- t o - d o o r i n f o r m a t i o n , c a n v a s s i n g a c t i v i t y o r

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

MEDICINAL PRODUCTS (ADVERTISING)

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) 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) 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 subregulation (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

subregulation (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

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 subregulation (1), 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 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

t o p rescri be or sup ply such pro ducts may, not with standi ng

paragraphs (a) and (b), 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 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 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 subregulation (1), 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 ben efits in k ind may be suppl ied, offered or

promised to 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)

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 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.

(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

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,

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(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

o ne o r m o re c o m pa ni e s no m in a t e d b y hi m t o c o - pr o mo t e a

medicinal product.

Advertising of homeopathic medicinal products referred to

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

Regulations 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 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.