19. June 2013
In a case decided on 11th April 2013 (C-535/11) judges at the European Court of Justice were tasked with answering an important medical law question: namely, whether the repackaging of human medicinal products requires prior authorisation. The pharmaceutical industry now has clear guidance. Under certain circumstances, businesses do not require prior authorisation to repackage medicinal products.
The case was referred to the ECJ by the regional court of Hamburg and concerned a company which had transferred medicinal liquid solutions, from vials to syringes. The syringes were then sold by the defendant more cheaply than the original vials. Prior authorisation is required to produce the liquid solutions. However, the defendant had not obtained any specific authorisation to repackage the medicinal products.
Whether this process breaches European competition law and whether the repackaging of medicinal products, requires prior authorisation, is a topic which is closely linked to the European Union’s Regulation on the Authorisation and Supervision of Medicinal Products (EC No 726/2004). As a result the Hamburg court sought a preliminary ruling from the ECJ.
Authorisation to repackage human medicinal products
The ECJ ruled that there is no requirement to seek prior authorisation when repackaging medicinal products, provided the repackaging is limited to individual prescriptions and the medicinal solutions are not altered.
The ECJ justified its decision by saying that as the repackaging takes place when the products are already available for purchase, the process did not amount to placing new products on the market. The defendant in this case was simply undertaking a task which doctors or hospital staff would do anyway.
The decision brings clarity to an important question in the area of pharmaceutical and medical law. The ECJ has laid down clear rules on when authorisation is required in order to repackage human medicinal products.
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Categories: Medical Law