Medical Preparations (Advertising) (Amendment) Regulations, 1996

• Jurisdiction: Ireland
• Year: 1996
• Citation: IR SI 308/1996

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. These Regulations may be cited as the Medical Preparations (Advertising) (Amendment) Regulations, 1996. 2. These Regulations shall be construed as one with the Medical Preparations (Advertising) Regulations, 1993 ( S.I. No. 76 of 1993 ) and may be cited together with those Regulations as the Medical Preparations (Advertising) Regulations, 1993 and 1996. 3. The Medical Preparations (Advertising) Regulations, 1993 are hereby amended by-

(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...