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S.I. No. 360/2005 - European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005

Type Statutory Instrument

Publication 2005-07-12

Last updated 2018-05-24

State In force superseded text

Text As published

Source Irish Statute Book

articles 30

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

7 amending acts · 2018-05-24, DATA PROTECTION ACT 2018

Reform history JSON API

(ii) the additional criteria, if any, which blood establishments are required to adopt in relation to it pursuant to subparagraph (a).

Fees.

29.

(1) The IMB may charge fees which shall be equal to the respective amounts which the IMB estimates it will incur in, or in connection with, performing the functions referred to in these Regulations to which the fees respectively relate.

(2) Where the costs incurred—

(a) are greater than the appropriate fee, then the difference between those costs and that fee shall be payable by the blood establishment concerned or its authorised representative, or the person responsible for the management of the hospital blood bank concerned or his or her authorised representative, as the case may be, to the IMB and

(b) are less than the appropriate fee, the difference between those costs and that fee shall be repayable by the IMB to the blood establishment concerned or its authorised representative, or the person responsible for the hospital blood bank concerned or his or her authorised representative as the case may be.

Transitional provisions.

30.

(1) Subject to paragraph (2), these Regulations, other than Regulations 17 and 23, shall not apply before 8 November 2005 in relation to—

(a) any blood establishment, and

(b) any hospital blood bank.

(2) From the commencement of this Regulation—

(a) a blood establishment may make an application under Regulation 6(2), and

(b) authorisation under Regulation 6(5) may be granted to a blood establishment before 8 November 2005 but any such authorisation shall not have effect before that date.

SCHEDULE EUROPEAN COMMUNITIES (QUALITY AND SAFETY OF HUMAN BLOOD AND BLOOD COMPONENTS) REGULATIONS 2005

Certificate stating results of test, examination or analysis

This certificate is issued by me, the undersigned, for the purpose of Regulation 21 of the European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005, being—

¹ _____.

I hereby certify that I received, on the ___ day of _ _, from ²___ of __ a sample of the relevant thing/the relevant thing*, being ³_ for test, examination or analysis: which was undamaged, duly sealed and marked ⁴ ___.

I further certify that the said sample/relevant thing* has been tested examined or analysed by me or under my direction and that the results are as follows—


Signature	______
Date	______
Address	____ ____ ______

Here insert official title of person signing the certificate.

Here insert the name of the authorised officer who submitted the sample of the relevant thing, or the relevant thing, as the case may be.

Here insert the name or description of the relevant thing.

Here insert distinguishing mark on the sample of the relevant thing, or the relevant thing, as the case may be, and the date shown on its container as the date of sampling, or the date on which the relevant thing was taken into possession, as the case may be.

Here insert the relevant results as appropriate.

Delete whichever is inapplicable.


	GIVEN under the Official Seal of the Minister for Health and Children, this 12th day of July 2005.
	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 interpretation.)

These Regulations give effect to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, and Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components.

The Regulations may be cited as the European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005.

The Regulations apply to the collection and testing of blood and blood components, whatever their intended purpose. The Directive also applies to the processing, storage and distribution of blood and blood components, but only when they are intended to be used for transfusion. The Regulations do not apply to stem cells.

Footnotes

OJ L33 of 8.2.2003, p. 30.

OJ L311 of 28.11.2001, p. 67.

OJ L91 of 30.3.2004, p. 25.

O.J. L281 of 23.11.1995, p. 31.

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