S.L. 483.4 Art. 3Definitions.

For the purposes of these regulations:

"the Authority" means the Licensing Authority;

"critical" means potentially having an effect on the quality and, or safety of, or having contact with, the cells and tissues; "donation identification sequence" means the first part of the Single European Code consisting of the EU tissue establishment code and the unique donation number; "EU Coding Platform" means the IT platform hosted by the Commission which contains the EU Tissue Establishment Compendium and the EU Tissue and Cell Product Compendium; "EU Tissue and Cell Product Compendium" means the register of all types of tissues and cells circulating in the Union and the respective product codes under the three permitted coding systems (EUTC, ISBT128 and Eurocode); "EU tissue establishment code" means the unique identifier for accredited, designated, authorised, or licensed tissue establishments in the Union. The tissue establishment code consists of an ISO country code and the tissue establishment number set out in the EU Tissue Establishment Compendium, as further specified in Schedule VII to these regulations; "EU Tissue Establishment Compendium" means the register of all tissue establishments which are authorised, licensed, designated or accredited by the Member States’ competent authority or authorities and which contains the information about these tissue establishments as set out in Schedule VIII; "EUTC" means the product coding system for tissues and cells developed by the Union consisting of a register of all types of tissues and cells circulating in the Union and their corresponding product codes; "expiry date" means the date by which the tissues and cells can be applied, as further defined in Schedule VII; "organisations responsible for human application" means a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells; "partner donation" means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;

"pooling" means the physical contact or mixing in a single container, of tissues or cells from more than one procurement from the same donor, or from two or more donors; "procurement organisation" means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment; "product code" means the identifier for the specific type of tissue and cell in question. The product code consists of the product coding system identifier indicating the coding system used by the tissue establishment ("E" for the EUTC, "A" for ISBT128, "B" for Eurocode) and the tissues and cells product number foreseen in the respective coding system for the product type, as further defined in Schedule VII; "product identification sequence" means the second part of the Single European Code consisting of the product code, the split number and the expiry date; "qualification" has the same meaning as "validation"; "quality management" means the coordinated activities to direct and control an organisation with regard to quality; "quality system" means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly;

"released for circulation" means distribution for human application or transfer to another operator, e.g. for further processing with or without return; "reproductive cells" means all tissues and cells intended to be used for the purpose of assisted reproduction; "Single European Code" or "SEC" means the unique identifier applied to tissues and cells distributed in the Union. The Single European Code consists of a donation identification sequence and a product identification sequence, as further specified in Schedule VII; "split number" means the number which distinguishes and uniquely identifies tissues and cells having the same unique donation number and the same product code and originating from the same tissue establishment, as further defined in Schedule VII;

"Standard Operating Procedures" (SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product; "traceability" means the ability to locate and identify the tissue or cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue or cells, and the ability to identify the recipients at the medical facilities applying the tissue or cells to the recipients; traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues or cells;

"unique donation number" means the unique number attributed to a specific donation of tissues and cells in line with the system in place in each Member State for allocating such numbers, as further specified in Schedule VII; "validation" (or "qualification" in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use;

"within the same centre" means that all steps from procurement to human application are carried out under the same responsible person, quality management system and traceability system, within a healthcare centre comprising at least an accredited, designated, authorised, or licensed tissue establishment and an organisation responsible for human application at the same location.