Description of the activity
Manufacture of active pharmaceutical ingredients (API) or active substances.
The economic activities in this category could be associated with NACE code C21.1 in accordance with the statistical classification of economic activities established by Regulation (EC) No 1893/2006.
Technical screening criteria
Substantial contribution to pollution prevention and control
1. The activity complies with all of the requirements specified below relating to product substitution.
1.1. The API complies with one of the following requirements:
(a) the API is a naturally occurring substance, such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids, and, in line with the European Medicines Agency Guideline on the environmental risk assessment of medicinal products for human use (EMA ERA guideline) [European Medicines Agency Guidelines on the environmental risk assessment of medicinal products for human use, version of 27.6.2023.],
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