Cross-border rules on medicinal products clarified by CJEU

12/07/2021 21 Views
Cross-border rules on medicinal products clarified by CJEU

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 the 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.

Regarding the procedure of mutual recognition of a MA, laid down in the ‘Medicines Directive’, the Court finds that it takes place under strict conditions and that it is conditional on a request by an MA holder for a given medicinal product in a Member State with a view to recognising that MA in the other Member States, a situation which does not correspond to the circumstances of the present case.

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