# The Human Medicines Regulations 2012, Paragraph 5


If requested by the licensing authority, an evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8A/paragraph/5 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8A/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.