{"id":34341,"date":"2023-03-16T10:15:00","date_gmt":"2023-03-16T09:15:00","guid":{"rendered":"https:\/\/faus-moliner.com\/ratificacion-del-principio-de-vis-atractiva-del-medicamento\/"},"modified":"2023-12-01T16:50:41","modified_gmt":"2023-12-01T15:50:41","slug":"ratificacion-del-principio-de-vis-atractiva-del-medicamento","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/ratificacion-del-principio-de-vis-atractiva-del-medicamento\/","title":{"rendered":"Ratification of the principle of primacy of application of the legal regime on medicinal products"},"content":{"rendered":"\n

Background<\/strong><\/p>\n\n\n\n

On 19 January 2023, the Court of Justice of the European Union (CJEU) issued a new judgement answering some questions on the definitions of medicinal product and medical device, at the request of the German Supreme Administrative Court.<\/p>\n\n\n\n

The case concerned two products (nasal drops and nasal spray) marketed in Germany as medical devices. In both cases, the German health authorities declared that they should have the regulatory status of medicinal products and therefore require an administrative authorisation for their marketing.<\/p>\n\n\n\n

In particular, they stated that both products met the definition of a medicinal product both “by function” (in both cases the effect on the symptoms of nasal congestion was achieved by a pharmacological action) and “by presentation” (the products were presented in such a way that a “reasonably well-informed and observant” consumer could associate them with medicinal products).<\/p>\n\n\n\n

The marketing companies appealed the administrative decisions before the referring courts. Their arguments were initially rejected, and, in the context of these proceedings, four questions were referred to the CJEU for a preliminary ruling. These questions raise doubts as to the scope of European legislation on medical devices and medicinal products for human use, in particular as regards:<\/p>\n\n\n\n