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These Regulations, made by the Council of Ministers, pursuant to subsection (4) of article 23 and article 54 of the Waste Law, no. 185 of 2011, concerns management of waste of pharmaceutical products for human use of household origin. The Regulations define: licence to manufacture pharmaceutical products and related fees; waste specialised medicinal products of household and domestic origin; specialty medicinal products; homeopathic medicinal products; pharmaceutical product of plant origin. Matters covered by these Regulations include: preventing the generation of waste of pharmaceutical products of domestic origin; reducing or eliminating the negative effects of production and the management of waste pharmaceutical products; reducing the final disposal of waste pharmaceutical products; establishing systems for the separate collection of waste pharmaceutical products; promoting the application of the "polluter pays" principle; specific requirements and prohibitions concerning management of waste pharmaceutical products; obligations of producer of pharmaceutical products; measures to limit the waste harmful effects on the environment and on human health.
Regulations no. 80 of 2023 on Waste (Management of Waste Pharmaceutical Products of Household Origin).
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