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Activities related to human medicines in Romania: Legal environmental protection issues
فعالیت های مربوط به داروهای انسانی در رومانی: موارد قانونی حمایت از محیط زیست-2020 Current environmental research focuses extensively on pharmaceutical waste, demonstrating the contamination
caused by active pharmaceutical ingredients. Regulations and programs to evaluate, prevent, and reduce environmental
risks linked to human medicines are currently being developed in various countries. We assessed the
Romanian legislation to identify the potential areas of development of environmental protection policies in the
pharmaceutical field. Laws and regulations of interest were selected, and their relevant provisions were analysed
using methods of legal interpretation, then corelated with their equivalent in more developed countries.
Romanian legislation requires an evaluation of the environmental impact of human medicines, an assessment of
non-clinical research and pharmaceutical manufacturing projects, appropriate management of pharmaceutical
waste and its disposal on a contract basis, and the collection and disposal of expired or unused medicines by
pharmacies. In practice, however, a coherent system for pharmaceutical waste management is lacking because of
many legal loopholes in environmental protection. Romanian legislation does not include specific rules regarding
sound environmental practice for clinical research laboratories, pharmaceutical manufacturers, and
wholesale distributors. The pharmaceutical industry has no legal responsibility to manage and dispose expired or
unused medicines collected from the population. Equitable sharing of environmental responsibility by the
pharmaceutical industry actors along with the involvement of public authorities should be established via legislation
and regulation that reflect the requirements mandated by other more advanced countries. Additionally,
continuous training programs should be provided for practitioners to reinforce their role in the rational use of
medicines and professional campaigns should be created to raise public awareness about preventing environmental
contamination. Keywords: Human medicines | Pharmaceutical waste | Environmental protection | Legislative measures |
مقاله انگلیسی |
2 |
Activities related to human medicines in Romania: Legal environmental protection issues
فعالیت های مربوط به داروهای انسانی در رومانی: موارد قانونی حمایت از محیط زیست-2020 Current environmental research focuses extensively on pharmaceutical waste, demonstrating the contamination
caused by active pharmaceutical ingredients. Regulations and programs to evaluate, prevent, and reduce environmental
risks linked to human medicines are currently being developed in various countries. We assessed the
Romanian legislation to identify the potential areas of development of environmental protection policies in the
pharmaceutical field. Laws and regulations of interest were selected, and their relevant provisions were analysed
using methods of legal interpretation, then corelated with their equivalent in more developed countries.
Romanian legislation requires an evaluation of the environmental impact of human medicines, an assessment of
non-clinical research and pharmaceutical manufacturing projects, appropriate management of pharmaceutical
waste and its disposal on a contract basis, and the collection and disposal of expired or unused medicines by
pharmacies. In practice, however, a coherent system for pharmaceutical waste management is lacking because of
many legal loopholes in environmental protection. Romanian legislation does not include specific rules regarding
sound environmental practice for clinical research laboratories, pharmaceutical manufacturers, and
wholesale distributors. The pharmaceutical industry has no legal responsibility to manage and dispose expired or
unused medicines collected from the population. Equitable sharing of environmental responsibility by the
pharmaceutical industry actors along with the involvement of public authorities should be established via legislation
and regulation that reflect the requirements mandated by other more advanced countries. Additionally,
continuous training programs should be provided for practitioners to reinforce their role in the rational use of
medicines and professional campaigns should be created to raise public awareness about preventing environmental
contamination. Keywords: Human medicines | Pharmaceutical waste | Environmental protection | Legislative measures |
مقاله انگلیسی |