Transcription of Guideline on the environmental risk assessment of medicinal …
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Guideline on the environmental risk assessment of medicinal …
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 15 November 2018 1 EMEA/CHMP/SWP/4447/00 Rev. 1 2 Committee for medicinal Products for human Use (CHMP) 3 Guideline on the environmental risk assessment of 4 medicinal products for human use 5 Draft 6 Draft agreed by Safety Working Party October 2018 Adopted by CHMP for release for consultation 15 November 2018 Start of public consultation 1 December 2018 End of consultation (deadline for comments) 30 June 2019 7 This Guideline replaces Guideline on the environmental risk assessment of medicinal products for 8 human use (EMEA/CHMP/SWP/4447/00 corr 2) . 9 10 Comments should be provided using this template.
58 hazards of human medicinal products (HMP). It specifies the scope and legal basis for assessment. It 59 outlines general considerations and the recommended step- wise procedure of assessment. The general 60 outline of the Environmental Risk Assessment Report is …
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