# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 1.8: Method of manufacture (synthesis pathway) of the active substance

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

The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.
Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/1/division/1.8 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-1/division-1.8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.