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SCHEDULE 2Directions for securing compliance with the first, second and third Directives

Traceability and coding system

1.  Directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure—

(a)in relation to traceability, compliance with the requirements of Article 8 (traceability) of the first Directive and Article 9 (traceability) of the third Directive; and

(b)in relation to the coding of information, compliance with the requirements of Article 25 (coding of information) of the first Directive and Article 10 (European coding system) of the third Directive.

2.  Directions given for the purposes of paragraph 1 shall include directions requiring designated individuals to ensure that third parties responsible for human application retain the information listed in Annex VI (information on the minimum donor/recipient data set to be kept) and Annex VII (information contained in the European coding system) to the third Directive.