Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance) (c. 566)

ANNEX III Minimum requirements concerning the documentation to be made available to the competent authority or authorities by tissue establishments intending to import tissues and cells from third countries

With the exception of one-off imports as defined in Article 2 of this Directive which have been exempted from these documentation requirements, the applicant importing tissue establishment shall make available and, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as an importing tissue establishment or tissue establishment, shall provide when requested by the competent authority or authorities the most up-to-date version of the following documents regarding the applicant and its third country supplier(s).

A. Documentation relating to the importing tissue establishment

1.

A job description of the Responsible Person and details of his/her relevant qualifications and training record as laid down in Directive 2004/23/EC;

2.

A copy of the primary label, repackage label, external package and transport container;

3.

A list of relevant and up-to-date versions of standard operating procedures (SOPs) relating to the establishment's import activities including SOPs on applying the Single European Code, reception and storage of imported tissues and cells at the importing tissue establishment, management of adverse events and reactions, management of recalls and traceability from donor to recipient.

B. Documentation relating to the third country supplier or suppliers

1.

A detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained from the donor or donor family and whether the donation was voluntary and unpaid or not;

2.

Detailed information on the testing centre(s) used by third country suppliers and the tests performed by such centres;

3.

Detailed information on the methods used during the processing of the tissues and cells including details of the validation for the critical processing procedure;

4.

A detailed description of the facilities, critical equipment and materials and criteria used for quality control and control of the environment for each activity carried out by the third country supplier;

5.

Detailed information on the conditions for release of tissues and cells by the third country supplier or suppliers;

6.

Details of any sub-contractors used by the third country suppliers including the name, location and activity undertaken;

7.

A summary of the most recent inspection of the third country supplier by the third country competent authority or authorities including the date of the inspection, type of inspection and main conclusions;

8.

A summary of the most recent audit of the third country supplier carried out by, or on behalf of, the importing tissue establishment;

9.

Any relevant national or international accreditation.