Regulation 7 Amendment of regulation 3(5)

after paragraph (a)(i) insert—

“(ia)

in the definition of “a case of emergency” omit “into the United Kingdom”;

(ib)

in the definition of “importing licence holder” omit “into the United Kingdom”;”;

in paragraph (a)(ii), for the substituted definition of “third country” substitute—

• ““third country” means—

  1. (a)

     in relation to the import of tissues or cells into, or the export of tissues and cells from, Great Britain, a country other than the United Kingdom;

  2. (b)

     in relation to the import of tissues or cells into Northern Ireland, a country other than Northern Ireland or an EEA state; and

  3. (c)

     in relation to the export of tissues or cells from Northern Ireland, a country other than the United Kingdom or an EEA state;”;

after paragraph (a)(ii) insert—

“(iia)

for the definition of “third country premises” substitute—

• ““third country premises”, in relation to Northern Ireland, means premises in a country other than Northern Ireland or an EEA state on or from which a third country supplier procures, tests, processes, stores, distributes or exports tissues or cells that are intended for import into Northern Ireland for human application;”;

(iib)

for the definition of “third country supplier” substitute—

• ““third country supplier” means—

  1. (a)

     in relation to tissues or cells intended for import into Great Britain for human application, a person in a country other than the United Kingdom who has an agreement with an importing licence holder for exporting such tissues or cells to Great Britain; and

  2. (b)

     in relation to tissues or cells intended for import into Northern Ireland for human application, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licence holder for exporting such tissues or cells to Northern Ireland;”;”;

for paragraph (b) substitute—

“(b)

for paragraph (4)(b) substitute—

“(b)

any reference in these Regulations to a requirement of any provision of the first, second, third or fourth Directive—

(i)

in the application of these Regulations in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland;

(ii)

in the application of these Regulations in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed in relation to the procurement, testing, processing, storage, distribution, import or export of tissue or cells intended for human application.”.”.