# Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance), Division II.1: Availability of alternative medicines

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

The need for the substance in order to avoid unnecessary suffering for target animals or to ensure the safety of those treating them may be relevant factors to consider in those cases where practical treatment alternatives are lacking. These considerations may justify acceptance of a reduced data package in line with the recommendations provided in guidance issued by the appropriate authority. These factors may also be considered in relation to the need to set MRLs at levels that will allow development of a product with a practicable withdrawal period, ....

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/II/division/II/division/II.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-II/division-II/division-II.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.