S.I. No. 187/1999 - Medical Preparations (Labelling and Package Leaflets) (Amendment) Regulations, 1999

1. These Regulations may be cited as the Medical Preparations (Labelling and Package Leaflets) (Amendment) Regulations, 1999.

2. These Regulations shall be construed as one with the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 and 1994 and may be cited together as the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 to 1999.

3. The Medical Preparations (Labelling and Package Leaflets) 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 deletion of article 10 and the substitution therefor of the following:—

“10. A product authorisation granted or renewed by the Board pursuant to Article 7 of the Medicinal Products (Licensing and Sale) Regulations, 1998 (

S.I. No. 142 of 1998

) may provide for exemption of any of the requirements of these Regulations as regards the particulars which should appear on labels and package leaflets where the Board is of the opinion that the product is not intended to be delivered to a patient for self administration.”;

(

c

) the insertion in article 13 of:—

“(iv) officers of the Board.”;

GIVEN under the Official Seal of the Minister for Health and Children, this 17th day of June, 1999.

BRIAN COWEN,

Minister for Health and Children.

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

The purpose of these Regulations is to give powers of enforcement in relation to the labelling of and package leaflets pertaining to medicinal products to the Irish Medicines Board and related matters.

The Minister for Health and Children, (as adapted by the Health (Alteration of Name of Department and Title of Minister) Order, 1997 (

S.I. No. 308 of 1997

)), in exercise of the powers conferred on him by

Section 32

of the

Irish Medicines Board Act, 1995

(No. 29 of 1995), hereby makes the following regulations:—