The Medical Preparations (Advertising) Regulations, 1993

• Jurisdiction: Ireland

S.I. No. 76 of 1993.

THE MEDICAL PREPARATIONS (ADVERTISING) REGULATIONS, 1993.

The Minister for Health, in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) hereby makes the following Regulations:— 1. These Regulations may be cited as The Medical Preparations (Advertising) Regulations 1993. 2. (1) In these Regulations—

"advertising" includes

(i) every form of advertising, whether in a publication, or by the display of any notice, or by means of any letter (whether circular or addressed to a particular person), press release or other document, or by words inscribed on any article, or by the exhibition of a photograph or cinematograph, or by way of sound recording, sound broadcasting or television or in any other way,

(ii) any form of door to door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medical preparations and including in particular

( a ) the advertising of medical preparations to the general public,

( b ) the advertising of medical preparations to persons qualified to prescribe or supply them,

( c ) visits by medical sales representatives to persons qualified to prescribe medical preparations,

( d ) the supply of samples of medical preparations,

( e ) the provision of inducements to prescribe or supply medical preparations by the gift, offer or promise of any benefit or bonus, whether in money or in kind,

( f ) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medical preparations,

( g ) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medical preparations and in particular payment of their travelling and accommodation expenses in connection therewith,

and cognate words shall be construed accordingly;

"health professional" means a person of any of the following classes:

(i) registered medical practitioners or registered dentists

(ii) persons registered in any of the registers provided for in the Pharmacy Acts, 1875 to 1977;

"the Minister" means the Minister for Health;

"product authorisation" means a licence granted or renewed by the Minister under Article 6 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, ( S.I. No. 210 of 1984 ), as amended, for the sale or manufacture for sale of a medical preparation;

"summary of product characteristics" means the summary of product characteristics referred to in Article 6 (4) of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, ( S.I. No. 210 of 1984 ) as amended.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule. 3. The provisions of these Regulations do not apply to—

(i) the labelling of medical preparations and the accompanying package leaflets,

(ii) correspondence of a non-promotional nature needed to answer a specific question about a particular medical preparation,

(iii) factual, informative announcements and reference material relating to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims and provided they relate to a medical preparation which is subject to a product authorisation. 4. A person shall not advertise a medical preparation in respect of which a product authorisation has not been granted and shall ensure that—

(i) all parts of his advertising of a medical preparation shall comply with the particulars listed in the summary of product characteristics in respect of that medical preparation and that,

(ii) the advertising by him of a medical preparation shall encourage the rational use of the medical preparation by presenting it objectively and without exaggerating its properties and shall not be misleading. 5. Subject to the provisions of Article 7 a person shall not advertise any medical preparation which

(i) by virtue of the Medical Preparations (Prescription and Control of Supply) Regulations 1993 ( S.I. No. 69 of 1993 ) may not be sold except in accordance with a prescription, or

(ii) is a controlled drug under Section 2 of the Misuse of Drugs Act 1977 (No. 12 of 1977). 6. (1) Subject to the provisions of Article 7 a person shall not publish or take any part in the publication of an advertisement referring to any medical preparation in a manner which might lead to the use of such preparation in the diagnosis, prevention or treatment in human beings of an ailment, infirmity, injury or defect set out in Schedule 1 or of any form of an ailment, infirmity, injury or defect set out in Schedule 1.

(2) A person taking part in the publication of an advertisement to which sub-article (1) applies shall be deemed not to have contravened that sub-article where the advertisement was published in such circumstances that he did not know and could not by the exercise of reasonable care have known that he was taking part in the publication thereof. 7. The provisions of Articles 5 and 6(1) shall not apply in relation to an advertisement which was published

(i) in such a manner and insofar as was reasonably necessary to bring it to the notice of the following persons:

( a ) health professionals

( b ) nurses within the meaning of the Nurses Act 1985 (No. 18 of 1985)

( c ) persons undergoing training with a view to becoming members of any of the classes specified at (a) and (b) above

( d ) persons who in the course of their business or profession provide training or instruction to persons undergoing training with a view to obtaining a qualification specified in (a) or (b) above

( e ) persons who in the course of their business or profession are engaged in the preparation or publication of advertisements addressed to persons referred to in (a) to (d) above.

( f ) members of either House of the Oireachtas, officials of a Government Department or of a health board, members and officials of the National Drugs Advisory Board or members of the governing body of a hospital or similar institution.

(ii) ( a ) in an imported book, periodical, newspaper or other publication and referred to a medical preparation which is not sold or intended for sale in the State or to persons resident in the State or

( b ) by a health board or by or with the consent of the Minister. 8. (1) A person who advertises a medical preparation to the general public shall ensure that such advertising conforms to the requirements set out in Schedule 2.

(2) In the case of an advertisement to the general public which is intended solely as a reminder, the person so advertising the medical preparation shall include

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