Medicines: regulatory context

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Medicinal product assessments based on Directives 2001/83/EC (human medicines) or 2001/82/EC (veterinary medicines) require assessment of the medicinal product’s impact on the environment; the objective is to assess the potential harmful effects of medicinal products on the environment and seek all precautions for use which might reduce these risks.

This environmental risk assessment is mandatory for all new market authorisation applications (new medicinal products, including generic), and may also be requested for market authorisation renewals. For extensions of indications and variations, a specific environmental assessment is required if the modification may result in an increased level of environmental exposure.

The ecotoxicological risk assessment proceeds in two stages: first an exposure assessment (phase I), and then, if necessary, an effects assessment (phase II). These 2 stages consist of:

  • Phase I: PBT assessment and assessment of level of environmental exposure to the product (to its active substances and/or their pertinent metabolites)
  • Phase II: assessment of the effect of the product on ecosystems: behaviour in various compartments of the environment (soil, water, air) and effects on non-target organisms

The following are exempt from this assessment: physiological substances (amino acids, vitamins, etc.), medicines derived from plants and vaccines.

For veterinary medicinal products, the ecotoxicological risk may lead to rejection of the market authorisation if it is deemed to outweigh the expected benefits. So the stakes are high.

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