# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.2.4: Cell culture study

Extent: E+W+S+N.I.

This information must be reported for intracellular replicating micro-organisms, such as viruses, viroids or specific bacteria and protozoa, unless the information from Sections 1, 2 and 3 clearly demonstrates that the micro-organism does not replicate in warm-blooded organisms. A cell culture study shall be performed in human cell or tissue cultures of different organs. Selection can be based on expected target organs after infection. If human cell or tissue cultures of specific organs are not available, other mammal cell and tissue cultures can be used. For viruses, the ability to interact with the human genome is a key consideration.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/5/division/2/division/5.2/division/5.2.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-2/division-5.2/division-5.2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.