Commission Directive (EU) 2015/566Show full title

Article 5 Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment

1. Importing tissue establishments, having taken measures to ensure that any imports of tissues and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and that imported tissues and cells can be traced from the donor to the recipient and vice versa, shall apply for an accreditation, designation, authorisation or licence as an importing tissue establishment by:

(a) providing to the competent authority or authorities the required information and documentation as set out in Annex I to this Directive;

(b) making available and, when requested by the competent authority or authorities, providing the documentation listed in Annex III to this Directive.

2. Member States may choose to not apply the documentation requirements of Annex I, part F and Annex III to this Directive to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such 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.