# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (vii): In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.

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

If the studies are not performed using a single batch of the micro-organism, the similarity of the different batches has to be stated.
Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.

---
Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/n1/division/vii (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-n1/division-vii
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.