S.L. 483.4 Art. 14Transitional period.

Tissues and cells already in storage on 29 October 2016

shall be exempted from the obligations relating to the Single

European Code, provided the tissues and cells are released for circulation in the Union within five years following that date and under the condition that full traceability is ensured by alternative means. For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in regulation 13(1)(f). SCHEDULE I

(Regulation 4) Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in regulation 4 A. ORGANISATION AND MANAGEMENT