S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 (2004_si_878) | IE

ISB SI

Reg. 1 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 Open official source

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

ISB SI

Reg. 2 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 Open official source

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

)

.

ISB SI

Reg. 3 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 Open official source

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”

ISB SI

Reg. 4 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 Open official source

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.

GIVEN under my Official Seal this 22nd day of December 2004.

Mary Harney

___________

Minister for Health and Children

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.

ISB SI

Preamble S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 Open official source

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/EC

1

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

S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004

Statutory Text (5 Articles)

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