S.L. 483.8 Art. 7Duties of importing tissue establishments. S.L. 483.04

(1) The importing tissue establishments shall not undertake any substantial changes, such as changes to the types of imported tissues and cells and activities undertaken in third countries which may have an influence on the quality and safety of imported tissues and cells or the third party suppliers, without the prior written approval of the Authority.

(2) When an importing tissue establishment undertakes a one-off import of tissues or cells originating from a third country supplier not covered by its existing accreditation, designation, authorisation or licence, such an import shall not be considered as a substantial change if the importing tissue establishment is authorised to import the same type of tissues and cells from another country supplier or suppliers.

(3) The importing tissue establishment shall inform the Authority in the case it ceases its import activities in full or in part.

(4) The importing tissue establishment shall notify without delay the Authority of any suspected or actual serious adverse event or reactions reported to them by third country suppliers which may influence the quality and safety of the tissues and cells they import. Such notification shall also include the information set out in Schedules III and IV of the Human Tissues and Cells

(Coding, Processing, Preservation, Storage and Distribution) Regulations.

(5) The importing tissue establishment shall, without delay, notify the competent authority of:

(a) any revocation or suspension, in whole or in part, of a third country supplier authorisation to export tissues and cells; and

(b) any other decision taken for reasons of non-compliance by the competent authority of the country in which the third country supplier is based and which may be relevant to the quality and safety of the imported tissues and cells.