S.I. No. 135/1958 - Medical Preparations (Advertisement and Sale) Regulations, 1958.
S.I. No. 135 of 1958.
MEDICAL PREPARATIONS (ADVERTISEMENT AND SALE) REGULATIONS, 1958.
1. These Regulations may be cited as the Medical Preparations (Advertisement and Sale) Regulations, 1958.
2. In these Regulations :
" the Minister " means the Minister for Health ;
" scheduled " means included in the Schedule to these Regulations ;
" British Pharmaceutical Codex " means the book published under that name by the Pharmaceutical Society of Great Britain ;
" local authority " means any of the following bodies—
(a) a health authority
(b) a board of assistance or board of public assistance
(c) a mental hospital authority
(e) the Dublin Fever Hospital Board.
3.—(1) These Regulations (except Article 6) shall come into operation on the 1st day of July, 1958.
(2) Article 6 of these Regulations shall come into operation on the 1st day of July, 1959.
4.—(1) Subject to the provisions of this Article, no person shall 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 a scheduled ailment, infirmity, injury or defect or of any form of a scheduled ailment, infirmity, injury or defect.
(2) A person taking part in the publication of an advertisement to which sub-article (1) of this Article 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.
(3) Sub-article (1) of this Article shall not apply in relation to an advertisement which—
(a) was published 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) was published by a local authority or by or with the consent of the Minister or
(c) was published in such a manner and only so far as was reasonably necessary to bring it to the notice of a person of any of the following classes :
(i) members of either House of the Oireachtas ;
(ii) local authorities ;
(iii) members of the governing body of a hospital or similar institution ;
(iv) registered medical practitioners or registered dentists ;
(v) nurses, within the meaning of the Nurses Act, 1950 (No. 27 of 1950) ;
(vi) persons registered in any of the registers of the Pharmaceutical Society of Ireland ;
(vii) persons undergoing training with a view to becoming members of any of the classes of persons specified in sub-paragraphs (iv) to (vi) of this paragraph.
5. Where a person has been found guilty of an offence by contravening Article 4 of these Regulations in respect of the publication of an advertisement of a medical preparation such person shall not sell or offer for sale such preparation save with the consent of the Minister and after compliance with any conditions (which may include a condition requiring the issue of a statement in a form and manner satisfactory to the Minister, negativing the effect of the advertisement) which he may impose.
6.—(1) Subject to the provisions of this Article, no person shall sell by retail a medical preparation unless there is legibly written on a label affixed thereto or, if the preparation is sold in a packet or container, unless there is legibly written on the outside of such packet or container or on a label affixed thereto—
(a) the appropriate designation of the preparation or of each of the active constituents thereof or of each of the ingredients from which it has been compounded and
(b) where the appropriate designation of each of the active constituents or ingredients is written as aforesaid, the appropriate quantitative particulars of the constituents or ingredients.
(2) Sub-article (1) of this Article shall not apply in relation to—
(a) the sale of an unadvertised preparation for the use of a particular person, having been prescribed by reference to his needs ;
(b) a sale from a packet or container in which a medical preparation is normally sold by retail without contravening sub-article (1) of this Article of a quantity of the preparation which is less than one-half of the complete contents of such packet or container.
(3) In this Article
" appropriate designation " in relation to any preparation, constituent or ingredient means—
(a) where the preparation, constituent or ingredient is described in any of the monographs contained in the current edition of the Irish Pharmacopocia or in the current edition of the British Pharmaceutical Codex, the description, or any synonym or abbreviation of that description, set out at the head of the monograph and
(b) where the preparation, constituent or ingredient is not so described, the accepted scientific name or other name descriptive of the true nature of the preparation, constituent or ingredient ;
" appropriate quantitative particulars " in relation to the active constituents or the ingredients of a preparation means the approximate percentage of each of the constituents or ingredients contained in the preparation or the approximate quantity of each of these constituents or ingredients contained in the packet or container or in a specified quantity of the preparation.
GIVEN under the Official Seal of the Minister for Health this tenth day of June, One Thousand Nine Hundred and Fifty-eight.
(Signed) SEÁN MACENTEE,
Minister for Health.
These regulations provide for the control of the advertisement and sale of medical preparations in respect of the human ailments mentioned in the schedule thereto.