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Medicnes Act, 2003 (Act No.Iii Of 2003) 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. (1) The title of these regulations is the Medicinal Products
(Advertising) Regulations, 2003.

Citation and commencement

2004.
(2) These regulations shall come into force on the 1st May,
2. 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<
“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<

Interpretation.

B 5304

Advertising.

3. (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.
include>
(3) The provisions of sub-regulation (1) hereof shall not
(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.
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.
5. (1) It shall not be lawful to advertise medicinal products for 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 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.
B 5305

Advertising quality.

Advertising criteria

Cap. 101.

Cap. 31.

B 5306

Method of advertising.

Excluded material in advertising.

(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.
6. 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.
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 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.
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.
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 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.
B 5307

Advertising material to persons qualified to prescribe

Minimum information on documents.

B 5308

No gifts, or pecuniary advantages or benefits in kind.

Free samples.

(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.
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 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.
11. (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.
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 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.
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 hereof,
(d) supply the advertisng committee with the information and assistance it requires to carry out its responsibilities,
B 5309

Sales representatives.

Detentur ta’ awtorizzazzjoni g[all-bejg[.

B 5310

Advertising committee.

(e) ensure that the decisions taken and conditions imposed by the advertising committee are immediately and fully complied with.
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.

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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

Prezz 16ç – Price 16c