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The Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998

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Section 4.8Pharmaceutical Production

Part A

The manufacture or the formulation of a medicinal product if the process may result in the release into water of any substance described in Schedule 5 in a quantity which in any 12 month period exceeds the background quantity by more than the amount specified in relation to the description of the substance in column 2 of Schedule 5.

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In this Section “medicinal product” means any substance or article (not being an instrument, apparatus or appliance) manufactured for use in one of the ways specified in section 130 (1) of the Medicines Act 1968(1).

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