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S.L. 483.8 · Equivalent Standards Of Quality And (S.L. 483.8)

S.L. 483.8 ст. 3Accreditation, designation authorisation or licensing by the Authority.

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(1) The Authority shall, without prejudice to the provisions of article 1(3), ensure that all imports of tissues and cells from third countries are undertaken by importing tissue establishments accredited, designated, authorised or licensed by it for the purposes of those activities.

(2) The Authority, after having obtained the information set out in Schedule I and after having verified that the importing tissue establishment complies with the relevant legislation, shall:

(a) accredit, designate, authorise or licence the importing tissue establishment to import tissues and cells;

(b) indicate any conditions which apply on the importing tissue establishment such as restrictions on the types of tissues and cells to be imported or the third country supplier to be used; and

(c) issue the importing tissue establishment with the certificate set out in Schedule II.