25As a preliminary point, it must be noted that, according to the Court’s settled case-law, Directive 2001/83 cannot apply to a medicinal product covered by a marketing authorisation in one Member State which is being imported into another Member State as a parallel import of a medicinal product already covered by a marketing authorisation in that other Member State, because the imported medicinal product cannot, in such a case, be regarded as being placed on the market for the first time in the Member State of importation. Such a situation therefore falls under the provisions of the TFEU on the free movement of goods, including Articles 34 and 36 TFEU (judgment of 3 July 2019, Delfarma, C‑387/18, EU:C:2019:556, paragraph 19 and the case-law cited), which, in essence, prohibit Member States, in principle, from imposing quantitative restrictions on imports and measures having equivalent effect, which may, however, be justified, inter alia, on grounds of the protection of health and life of humans.
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