# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (iii)

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

In the context of the influence that impurities can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as mentioned under point 1.11 of Part A be provided. Tests shall be conducted using active substance of that specification to be used in the manufacture of preparations to be authorised, except where radiolabelled material is required or permitted.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/1/division/iii (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-1/division-iii
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.