EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Directorate B - Health systems and products B4 - Medical Products : quality, safety, innovation EU Coding Platform User Manual SEC LookUp Version 1.0 EU Coding platform – SEC Lookup Page 1 SEC LookUp The Single European Code (SEC) is a standard fixed length alphanumeric code comprising information concerning the donation (Donation Identification Sequence) and the tissue or cell product (Product Identification Sequence). DI and PI SEC left menu link stands for Donor Identification and Product Identification within Single European Code. The format of the SEC has been established by the tissue and cell Competent Authorities together with the European Commission. The structure comprises two elements, the first containing donation specific information (a tissue establishment code, which is composed of the ISO Country code and a tissue establishment identifier code, and a unique donation number) and the second containing product specific information (coding system, product code, split number and expiry date). Details of field lengths and character types are as follows: Donation Identification Sequence (SEC DI) ISO Country Code 2 characters (alphabetic) TE Code TE number 6 characters (alpha/numeric) Unique Donation Number 13 characters (alpha/numeric) Product Identification Sequence (SEC PI) Product Coding System Identifier 1 character (alphabetic) Product Number Split Number Expiry Date 7 characters (alpha/numeric) 3 characters (alpha/numeric) 8 characters (numeric, YYYYMMDD) In the main page there are 3 options on how to search for a code/product. The first tab is for searching with the full code consisted of DI and PI sequences and search for full Tissue Establishment and Product Information details. The second and third tabs are for searching with only Donor Identification Sequence or Product Identification Sequence respectively. EU Coding platform – SEC Lookup Page 2 Example: If a tissue establishment in Belgium is assigned a TE identifier code by its CA of “A317”, then in the SEC the ISO Country Code will be “BE” and the TE number “00A317”. If that facility assigns a donation number of “491276” to a donation event, then all tissue or cell products prepared by the TE from that donation will be labelled with the following donation identification sequence as part of the SEC: “BE00A3170000000491276”. Once specified e.g. DI sequence the user will obtain the full information based on the provided string about the TE and its authorization status. EU Coding platform – SEC Lookup Page 3 If you provide only Product Identification Sequence, the searching result will be the Product, coding system and product category details. Example: - A product identified using ISBT 128 (coding system “A”) with an ISBT 128 product code of S1012 would have the first eight characters of the product identification sequence of the SEC as “A00S1012”. - A product identified as “Glycerolised Skin” which maps to EU Coding platform – SEC Lookup Page 4 the EUTC system (coding system “E”) code of “Skin, Full” with EUTC number 62 (see also 4.1. Structure of the Product Compendium) would have the first eight characters of the product identification element of the SEC as “E0000062”. Result: In following example the full DI and PI SEC code has been provided. This will show the full information about the TE, DI, PI, authorization status etc. EU Coding platform – SEC Lookup Page 5 From the left side menu you can also download a Sample SEC maker file: EU Coding platform – SEC Lookup Page 6 The purpose of this excel file is to show how the SEC is made. EU Coding platform – SEC Lookup Page 7 In the previous version in the next left menu option in LookUp module was a link to Tissue Establishments Search. This has now been moved under Compendia section. However the both user manuals are explaining this section: A click on this option will show all the Tissue Establishment currently operating in EU. EU Coding platform – SEC Lookup Page 8 There are several search and filter criteria. You can search against EU TE Code, TE Name, City, Country or anything via Global Search. You can also combine the Global Search with other filters. Once filtered you can also export TE list into several export formats. Currently available export formats are .XLS, .PDF, .XML, .CSV. EU Coding platform – SEC Lookup Page 9 EU Coding platform – SEC Lookup Page 10 Again, any result from combined search can be exported in various formats. After clicking on EU TE Code or TE Name, user will be presented with the Authorization status of the selected Tissue Establishment see below. EU Coding platform – SEC Lookup Page 11 To get back to TE List, click on Overview Tissue Establishments link. Do not click on browser button Back. Sometimes the color, labels, headers and names of the fields in applications and this manual might be slightly different, but the meaning and the functionality stays the same as described in this manual. EU Coding platform – SEC Lookup Page 12
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