S.I. No. 308/1996 - Medical Preparations (Advertising) (Amendment) Regulations, 1996

S.I. No. 308 of 1996.

MEDICAL PREPARATIONS (ADVERTISING) (AMENDMENT) REGULATIONS, 1996.

In exercise of the powers conferred on the Minister for Health by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 ( S.I. No. 24 of 1996 ), I, Brian O'Shea, Minister of State at the Department of Health, hereby make the following Regulations-

1.

2.

3.

• (a) the insertion in article 2(1) of the following definition

""the Board" means the Irish Medicines Board appointed pursuant to the Irish Medicines Board Act, 1995 (No. 29 of 1995);";

• (b) the substitution in article 2(1) of the following definitions for "product authorisation" and "summary of product characteristics"-

""product authorisation" means a licence granted, renewed or in force under the provisions of the Medical Preparations (Licensing and Sale) Regulations, 1996 ( S.I. No. 43 of 1996 ) or an authorisation granted or renewed under Council Regulation (EEC) No. 2309/93 of 22 July 1993^(1) laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of medicinal products;

^(1)OJ No. L214, 24.8.1993, pl

"summary of product characteristics" means the summary of product characteristics contained in a product authorisation;";

• (c) the substitution of the reference in article 5(i) to the "Medical Preparations (Prescription and Control of Supply) Regulations, 1993 ( S.I. No. 69 of 1993 )" by reference to the "Medicinal Products (Prescription and Control of Supply) Regulations, 1996 ( S.I. No. 256 of 1996 )";

• (d) the insertion in article 7(ii)(b) of the words "or the Board" after the word "Minister";

• (e) the deletion of article 11(2) and the substitution therefor of the following—

• "(2) "Where in the opinion of the Minister or the Board the requirements in relation to the training and scientific knowledge referred to in sub-article 1 are not being observed, the Minister or the Board, as the case may be, may specify the training and scientific knowledge so required.";

• (f) the deletion of Article 15(1)(b) and the substitution therefor of the following-

• "(b) proposes to issue or display or causes to be issued or displayed any advertisement which in the opinion of the Minister or the Board is misleading, shall, if so directed by the Minister or the Board, as the case may be, ensure that such advertisement or proposed advertisement is withdrawn and he shall in the case of an advertisement which has been issued or displayed, if further directed by the Minister or the Board, publish a corrective statement in a form and by a means acceptable to the Minister or the Board, as the case may be.";

• (g) (i) the insertion in article 17(2) of the words "or of the Board" after the word "Minister",

• (ii) the insertion in article 17(3) of the words "or the Board" after the first occurrence of the word "Minister" and by the insertion of the words "or the Board, as the case may be," after the second occurrence of the word "Minister";

• (h) the insertion in article 18 of—

• "(iv) officers of the Irish Medicines Board"

• (i) the deletion in Schedule 1 of the words "Alopecia (including male pattern baldness)".

Dated this 15th day of October, 1996

Brian O'Shea

Minister of State at the Department of Health.

Explanatory Memorandum

The effect of these Regulations is to permit the advertising to the public of medicinal products which are authorised and intended for the treatment of Alopecia (including male pattern baldness). The Regulations also give powers of enforcement and related matters to the Irish Medicines Board.