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Cortex - Life Sciences Insights

| 1 minute read

Judgment in Case C-178/20 - Pharma Expressz

On 8 July the Court of Justice of the European Union (CJEU) issued its judgement in Case C-178/20, concerning the placement on the market of medicinal products not subject to medical prescription in one Member State where a marketing authorisation (MA) has been granted by competent authorities. 

Recalling Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, the CJEU considered that if a medicinal product does not have an MA issued by the competent authorities of the Member State in which it is offered for sale, or an MA issued following the centralised procedure, it may not be placed on the market in that State, regardless of whether that same medicinal product may be sold in another Member State without a medical prescription.

Following the CJEU's reasoning, Directive 2001/83/EC does not require that a medicinal product which has been granted MA by a Member State as a medicinal product available without medical prescription also be classified as a medicinal product not subject to medical prescription in another Member State which has not authorised its placing on the market.

The Court further considered that Member States may adopt formalities concerning the transposition of Directive 2001/83/EC's rules allowing medicinal products to be placed on the market in a Member State even if no MA has been issued by that State or by the Commission with a view to meeting special medical needs. In this particular judgement, the CJEU considered the derogation to have been correctly transposed to national legislation, and hence the required formalities cannot be classified as quantitative import restrictions or as a measure having equivalent effect with regard to the principle of the free movement of goods.

A medicinal product not subject to medical prescription in one Member State may not be placed on the market in another Member State unless that Member State, too, has granted its marketing authorisation.


pharmaceuticals, europe, regulation-pharma