ANNEX IIIMinimum 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

A.Documentation relating to the importing tissue establishment

  1. 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. 2.

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

  3. 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.