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CJEU rules OTC drugs require local authorisation in Hungarian case

The Court of Justice of the European Union (CJEU) on Thursday ruled that an OTC drug cleared in one European Union member state may not be sold in another member state unless it has also been granted a marketing authorisation (MA) there.

The case was brought by Hungary’s Pharma Expressz, which was ordered by local authorities to cease the sale of OTC products which had been cleared in another member state in Hungary.

“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,” the CJEU said in its ruling.

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