Paragraph 5 F1
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.
Annotations
Textual amendments
- F1
Sch. 8A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 26 and Sch. 8A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 26