Statutory Instrument

S.I. No. 878 of 2004

European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004

S.I. No. 878 of 2004

European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004

I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972 ) and for the purpose of giving further effect to Directive 2001/20/EC¹ of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, hereby make the following regulations:

1.         These Regulations may be cited as the European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004.

2.         In these Regulations “Principal Regulations” mean the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004 ).

3.         Regulation 12(3) of the Principal Regulations is hereby amended by the substitution for sub-paragraph (a) of the following sub-paragraph --

“(a) for --

(i)    the whole State, or

(ii)   that part of the State in which the chief investigator is professionally based; and”

4.         Regulation 52 (1) of the Principal Regulations is hereby substituted by the following paragraph --

“(1) The fees that shall be payable to the Board in connection with --

(i)   any request for authorisation made to or accepted by the Board under Regulation 14, 15, 16 or 17, or

(ii)   any notice of amendment sent to the Board under Regulation 21, or

(iii)   any application made to or granted by the Board under Regulation 35 or 41,

shall be as determined by the Board with the approval of the Minister.

Explanatory Note

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

These Regulations make provision for the payment of charges for services provided by the Irish Medicines Board in respect of clinical trials conducted under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ). The charges are determined by the Irish Medicines Board subject to the approval of the Minister for Health and Children.

¹ OJ L. 121, 01.05.2001, p.34.