How can human health and life be effectively protected?
Member States have at their disposal several tools and procedures in order to safeguard public health and, in the case of medicinal products, a marketing authorisation is granted only after the product has been thoroughly checked. The marketing of a medicinal product having been authorised, it would be unnecessary, disproportionate, time consuming and costly to apply exactly the same procedure often involving extensive clinical tests – all over again to a product imported in parallel which is exactly the same or sufficiently similar to the one already authorised. Clearly, however, national authorities are entitled to confirm that a product imported in parallel is indeed the same or sufficiently similar to the “reference product” the one already authorised for circulation in their market. The parallel importer is accordingly required to submit all relevant information.
