20 July 2020 - Authored by:Lars Braams
A Marketing Authorization (MA) is required for selling melatonin in dosages above 0.3 mg. The Dutch Health Care Inspectorate (IGZ) warned repeatedly that it will enforce against the sale of such products, without having an MA.
On 16 June, the administrative court of Amsterdam published a decision according to which the decision of the Dutch Medicines Agency to refuse the application of an MA for such product was endorsed by the court. Initially the product at hand was (broadly) indicated for the treatment of insomnia, but during the MA application procedure the indication was limited to Sleep Onset Latency (SOL). It was not in dispute between the parties that this product would shorten SOL with 12 minutes. According to the Medicines Act, the Agency grants an MA if, amongst others, the product has the claimed therapeutic effect.
For its refusal-decision, the Dutch Medicines Agency relied on the EMA-Guideline on Medical Products for the Treatment of Insomnia (the Guideline). According to the MA applicant relying on this framework was not allowed, because of the limited indication of the product: treating prolonged sleep latency (difficulties in sleep initiation) that is not associated with an underlying medical condition. The applicant states that the agency incorrectly shifted the indication and (mis)used the Guideline to refuse the application. It further argued that shifting the indication was contrary to the requested registration for an OTC (over the counter) product. According to the court, the agency has a discretion and was allowed to rely on the Guideline for its decision, even if the applicant states that the product was not directed to insomnia patients. Therefore in its effectiveness assessment the Agency could take into account not only SOL, but also other factors such as improved day time functioning (which was not shown). The court also rejected the applicants secondary request to get the opportunity to show the improved day time functioning effect of her product. That ship had sailed.