engleski

Best Archiving Practice Guidance, v 1.0., June 2013

Survey on archives of European medicinal products agencies conducted in 2010 showed that majority of EU National Competent Authorities have not established policies, processes and systems for long-term preservation of electronic submissions. That is why Telematic Implementation Group on electronic Submission (TIGes) in 2011 gathered a specialised subgroup with the mandate of producing Best Archiving Practice guidance. Best Archiving Practice provides fundamental requirements for long-term preservation of electronic submissions in the National Competent Authorities and European Medicines Agency, and other recommendations that complete archival framework for long-term preservation. Fulfilment of basic requirements shall ensure long life of agencies’ archival holdings in the context of rapidly changing technological environment. It is scalable enough to serve as reference framework that meets various national demands, and it serves to harmonise various organisational practices within stated archival framework. In addition, it should provide direction for applicants who are preparing and submitting electronic submissions to the medicinal products agencies. When applying this guidance, National Competent Authorities and European Medicines Agency can store e-submission in a way which enables long-term preservation in digital archival information systems. These systems can be their own or those provided by third parties, e.g. national archiving authorities. Digital archival information systems are systems capable of preserving digital objects for long and pre-defined term. Digital archival information systems are not just repositories for storing digital documents, but complete solutions for proactive archival management of (complex) digital objects, their organisational context and provenance, with a goal of continued usage of these objects as authentic and trusted source of information and evidence. This document contains an overview of archiving guidelines for eSubmissions. Its Appendix 1 describes detailed specifications and recommendations regarding format of documents to be archived, archiving packages and archival information system. Document and archival package guidelines are applicable as such in all agencies whereas solutions to implement an archival information system vary.

best archival practice; eCTD

This document has been published under the auspices of the EU Telematics Implementation Group - electronic submissions (TIGes)