S.I. No. 42/1996:

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) (AMENDMENT) REGULATIONS, 1996.

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) (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 (Licensing of Manufacture) (Amendment) Regulations, 1995.

2. These Regulations shall be construed as one with the Medical Preparations (Licensing of Manufacture) Regulations, 1993 ( S.I. No. 40 of 1993 ) (hereinafter referred to as the "Principal Regulations") and the Medical Preparations (Licensing of Manufacture) 1993 (Amendment) Regulations, 1993 ( S.I. No. 68 of 1993 ) and may be cited together with those Regulations as the Medical Preparations (Licensing of Manufacture) Regulations, 1993--1995.

3. In these Regulations "the Board" shall mean the Irish Medicines Board appointed pursuant to the Irish Medicines Board Act, 1995 .

4. The Principal Regulations are hereby amended by:--

(1) the insertion in article 3 after "In these Regulations--" of ' "the Board" mean the Irish Medicines Board appointed pursuant to the Irish Medicines Board Act, 1995 .';

(2) the substitution of "the Board" for "the Minister" wheresoever it appears in articles 4, 7, 8 and 10, and in Schedules I and II of the Principal Regulations.

(3) the deletion of article 9 and the substitution therefor of the following:

"9. There shall be paid to the Board in respect of each manufacturer's licence an annual fee in accordance with such fees as the Minister may by regulation provide for.";

(4) the insertion in article 11 of ",officers of the Board" after "Minister".

5. These Regulations shall come into operation on the 19th day of February, 1996.

DATED this 13th day of February, 1996.

BRIAN O'SHEA,

Minister of State at the Department of Health.

EXPLANATORY NOTE.

These Regulations provide for the transfer from the Minister for Health to the Irish Medicines Board of the authority to grant manufacturers' licences and related matters.