Medicines Directive
The European Medicines Directive includes several authorization procedures for companies wishing to market a medicine in Europe. Besides an extensive authorization procedure, there is also a simplified procedure. This procedure can be followed when an application is made for a medicine whose active substances have long been registered as separate medicines. In that case, it is not necessary to prove that those substances are safe and effective, but only that the combination of active substances works and is safe for patients.
Procedure
In this case, the Medicines Evaluation Board granted authorization via the simplified procedure to five pharmaceutical companies for marketing a medicine consisting of a combination of two active substances. Organon had previously received a marketing authorization from the board for the same combination of substances. That authorization was also granted via the simplified procedure. Organon disagrees with the boards decision. The Noord-Holland court ruled in favor of Organon. According to the court, the simplified authorization procedure may only be applied once under the European Medicines Directive. For this reason, the court decided to revoke the authorizations granted to the five other companies. As a result, they currently no longer hold a marketing authorization.
Preliminary Questions to the European Court
The Administrative Jurisdiction Division notes that it is unclear whether the simplified authorization procedure may be applied more than once for medicines with the same combination of active substances. The European Medicines Directive is interpreted differently on this point. To avoid divergent case law, the Administrative Jurisdiction Division has submitted preliminary questions to the Court of Justice. They seek clarification from the Court on whether the simplified authorization procedure may be applied multiple times.
Suspension of Proceedings
The Administrative Jurisdiction Division suspends further proceedings in this case pending the answers from the Court of Justice in Luxembourg. Once the Court has issued its ruling, the Administrative Jurisdiction Division will resume proceedings and issue a final judgment in the case.