November 28
2021
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Emilija Berzanskaite
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25th November 2021
Consumer, Health & Environment Internal Market

Court of Justice: automatic expiration of parallel import licence of medicine solely due to expiration of marketing authorisation is precluded under EU law

Today, the Court of Justice held in Delfarma (C-488/20) that EU law precludes national legislation under which a parallel import licence of a medicinal product is to expire automatically after one year from the expiry of the marketing authorisation without carrying out an assessment of whether there is any risk to the health and life of humans. 

By decision of the Polish Minister for Health in 2011, Delfarma was granted a parallel import license from the Czech Republic to Poland for a medicinal product Ribomunyl on the basis of Polish marketing authorisation (‘MA’). In 2018 the MA for Ribymunyl in Poland expired and subsequently, one year later, a decision was adopted declaring the expiration of the parallel import licence. 

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