Commission Directive (EU) 2015/566Show full title

Article 7 U.K. Written agreements

1. Importing tissue establishments shall have in place written agreements with third country suppliers where any of the activities of donation, procurement, testing, processing, preservation, storage or export to the Union of tissues and cells to be imported into the Union are carried out outside of the Union.

Member States may choose to not apply this requirement to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such an imports. Those national measures shall ensure the following:

(a) traceability from donor to recipient and vice versa; and

(b) imported tissues and cells are not applied to anyone other than their intended recipients.

2. The written agreement between the importing tissue establishment and the third country supplier shall specify the quality and safety requirements to be met to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC. In particular, the written agreement shall include, as a minimum, the contents listed in Annex IV to this Directive.

3. The written agreement shall establish the right of the competent authority or authorities to inspect the activities, including the facilities, of any third country suppliers during the duration of the written agreement and for a period of 2 years following its termination.

4. Importing tissue establishments shall provide copies of written agreements with third country suppliers to the competent authority or authorities as part of their application for accreditation, designation, authorisation or licensing.