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Pateikimo data
06/08/2019
Atsakymo data
07/08/2019
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Informacija apie klausimą
Tema
Annex II - costing sheet Confidential waste
Klausimas
The costing sheet does not specify a required method for processing/destruction of confidential paper. Is our assumption correct that you want tenderers to quote for on-site destruction of confidential paper as described in paragraph 3.1.5h of the technical specifications?
Atsakymas
07/08/2019
As per technical specifications the destruction of confidential waste (including paper) has to be in line with applicable national legislation and good practice for confidential waste disposal, e.g. DIN norm 66399 or equivalent. If feasible, the preference would be that the destruction of confidential waste takes place on-site, and the process can be observed by an EMA representative.so on-site destruction is the Agency preference but other alternatives will be considered and evaluated.