Administrative organisation and structure
Article 4
1. The EU reference laboratories shall identify at least one person within its management as having overall responsibility for the performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746. 2. The EU reference laboratories shall have sufficient administrative staff to provide the necessary administrative support for performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746, in relation to the volume of those tasks. 3. The EU reference laboratories shall establish and keep up-to-date documentation containing the following: (a) evidence of their status as a legal entity; (b) where they are part of a larger organisation, a description of the activities of that organisation, its organisational structure and governance; (c) where they are, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position; (d) a description of their internal organisational structure with clearly allocated responsibilities and reporting lines; (e) a description of their operating procedures, including management and performance of tasks, management of staff, a staff substitution plan, as well as registration of documentation and correspondence with external entities; (f) a declaration that none of the situations for exclusion set out in Article 136 of Regulation (EU, Euratom) 2018/1046 apply to them; (g) evidence of their sources of funding and of economic viability without financial assistance from the Union; (h) detailed records of the calculation of the costs and the corresponding fees levied for each task they are requested to perform; (i) a yearly overview of the tasks performed. The EU reference laboratories shall make the documentation referred to in the first subparagraph available to the Commission, upon its request.