Storage and Distribution) (Amendment) Regulations, 2013

L.N. 304 of 2013

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Human Tissues and Cells (Coding, Processing, Preservation,

Storage and Distribution) (Amendment) Regulations, 2013

IN exercise of the powers conferred by article 16 of the Human

Blood and Transplants Act, the Minister for Health, after consultation

with the Licensing Authority, has made the following regulations:-

The title of these regulations is the Human Tissues and Citation.

Cells (Coding, Processing, Preservation, Storage and Distribution)

(Amendment) Regulations, 2013, and these regulations shall be read

and construed as one with the Human Tissues and Cells (Coding, S.L. 483.04

Processing, Preservation, Storage and Distribution) Regulations,

hereinafter referred to as "the principal regulations".

Immediately after sub-regulation (2) of regulation 1 of the Amends

principal regulations, there shall be added the following new sub- regulation

the principal

regulation

regulations.

"(3) The scope of these regulations is also to fully

transpose the European Parliament and Council Directive 2004/

23/EC of 31 March 2004 on setting standards of quality and

safety for the donation, procurement, testing, processing,

preservation, storage and distribution of human tissues and

cells.".

Immediately after sub-regulation (2) of regulation 2 of the Amends

principal regulations, there shall be added the following new sub- regulation

the principal

regulation

regulations.

"(3)

These regulations shall not apply to

(a) tissues and cells used as an autologous graft

within the same surgical procedure;

(b) blood and blood components as defined by

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;

(c) organs or parts of organs if it is their function

to be used for the same purpose as the entire organ in the

human body.".

Regulations 8 to 10 of the principal regulations shall be

Renumbers

regulations 8 to

renumbered as regulations 9 to 11 thereof respectively.

regulations.

Immediately after regulation 7 of the principal regulations,

regulation 8 to

there shall be added the following new regulation

the principal

regulations.

" Inspections,

(1) The Licensing Authority

etc., by

shall organise inspections and carry out

Licensing

control measures as appropriate whenever

Authority.

there is any serious adverse reaction or

serious adverse event. In addition, such an

inspection shall be organised and control

measures shall be carried out at the duly

justified request of the competent authority or

authorities in another Member State in any

such case.

(2) The Licensing Authority shall,

upon the request of another Member State or

the Commission, provide information on the

results of inspections and control measures

carried out in relation to the requirements of

these regulations.".

€0.18