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7.—(1) No person shall store tissue or cells intended for human application otherwise than under the authority of a licence under Schedule 1.
(2) Subject to paragraphs (4) and (6), no person shall do an activity to which this paragraph applies otherwise than—
(a)under the authority of a licence under Schedule 1, or
(b)in pursuance of a third party agreement.
(3) Paragraph (2) applies to the procurement, testing, processing, distribution, import or export of tissue and cells intended for human application.
(4) The Authority may authorise any person to distribute, import or export tissue or cells directly from where the procurement takes place to an organisation responsible for human application for immediate human application.
(5) The Authority may not authorise distribution, import or export under paragraph (4) unless—
(a)the authorisation relates to tissue or cells specified for the purposes of Article 6(5) of the first Directive, and
(b)the Authority is satisfied—
(i)that the distribution, import or export is necessary for clinical reasons, and
(ii)that the case is one of emergency.
(6) Paragraph (2) shall not apply to the distribution to or from, or to the import from or the export to, tissue establishments which are accredited, designated, authorised or licensed under the laws or other measures adopted in an EEA state other than the United Kingdom or in Gibraltar for the purpose of implementing the first, second and third Directives.
(7) Schedule 1 shall apply in relation to licences for the purposes of this regulation.