Pharmaceuticals

For your dossier preparation for the marketing authorisation of medicinal products for human use, the EMA requires environmental impact assessments to be carried out.The intended use of the product, the physico-chemical and ecotoxicological properties and the environmental behaviour of the product are determined. The necessary tests are listed below.

• Environmental behaviour
• Aquatic ecotoxicology
• Optional exams
• Further examinations and individualised studies on request

The EMA no longer requires routine acute six-pack studies for the authorisation of medicinal products.
for the authorisation of medicinal products. Instead, a scientifically sound approach is preferred that
that utilises existing data from preclinical studies and minimises the use of animal
minimises the use of animal testing.
However, six-pack studies may still be necessary if there is a particular need, which
the following area of toxicity:

• Acute oral toxicity
• Acute inhalation toxicity
• Acute dermal toxicity
• Skin irritation / corrosion
• Skin sensitisation
• Eye irritation / corrosiveness