Registration dossiers for substances and products: Medicines

Registration dossiers for active substances and products Medecines logo

The evaluation of medicinal products based on Directives 2001/83 / EC (human medicinal products) and 2001/82 / EC (veterinary medicinal products) requires assessment of the environmental impact of the medicinal product. The aim is to assess the potential harmful effects, which the use of the medicinal product may cause to the environment and to identify the risk of such effects. The assessment shall also identify any mitigation measure which may be necessary to reduce such risk.

This environmental risk assessment must be provided for each new marketing authorisation application (new medicinal products including generics products) and can also be necessary for authorisation renewal (extensions of indications, variations).

For the extension of indications and variations, a specific environmental assessment is needed when the amendment of the marketing authorisation may lead to an increase in the level of environmental exposure.

For veterinary medicinal products, a marketing authorisation should be refused where the estimated ecotoxicological risk is not outweighed by the expected benefit. The stakes are this important!

You need to

  • Write the ecotoxicological part of your marketing authorisation application (module 1.6) of your human medicinal products,
  • Prepare the environmental risk assessment for your veterinary medicinal products,
  • Write justification for categorical exclusion.

Our expertise

  • Write the environmental risk assessment of your medicinal products:
    • Phase I: PBT assessment and evaluation of the potential exposure of the environment to the product (to its active ingredient(s) and/or relevant metabolites),
    • Phase II: evaluation of the effects of the product on the ecosystems: behaviour in the different compartments (soil, water, air) and effects on non-target organisms
  • Determine acceptable levels of exposure of ecosystems (PNEC),
  • Evaluate the existing studies and identify missing or critical data gaps,
  • Prepare tailor-made risk assessments,
  • Assist you in your exchanges with the French or European authorities.

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