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The Quality and Safety of Organs Intended for Transplantation Regulations 2012

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This is the original version (as it was originally made).

Organs sent to another country

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18.—(1) Where an organ is sent to another country in the European Union, the Authority shall ensure that—

(a)information on organ and donor characterisation that is specified in part A of the Annex to the Directive;

(b)information that has been collected by a registered medical practitioner or a person acting under their supervision that is required by Part B of the Annex at the time when the organ is sent to another country in the European Union; and

(c)information to ensure the traceability of the organ,

is transmitted to that country in conformity with any procedures established by the Commission under article 29 of the Directive.

(2) Where an organ is sent to, or received from, a country in the European Union, the Authority shall ensure the reporting of serious adverse events and reactions in conformity with any procedures established by the Commission under article 29 of the Directive.

(3) The Authority shall ensure that any organs sent to, or received from, countries which are not in the European Union can—

(a)be traced from the donor to the recipient; and

(b)meet quality and safety standards that are equivalent to those required by these Regulations.

(4) For the purposes of paragraph (3), the Authority may conclude agreements with countries that are not in the European Union.

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