The judgment of the Higher Administrative Court of Münster of 29 November 2022 (Ref.: 9 A 2428/19) concerns the subsequent authorization of a homeopathic medicinal product whose efficacy could not be justified due to a lack of proof of the suitability of the excipients. It was also not possible to extend the authorization via the recognition procedure due to a lack of applicability.
The parties are in dispute about the extension of a fictitious marketing authorization (so-called subsequent authorization) for a homeopathic medicinal product. The plaintiff is seeking an extension of the marketing authorization for a medicinal product that is intended to treat febrile and flu-like infections as well as catarrh and inflammation of the nose and throat. In addition to homeopathic active ingredients, the preparation also contains excipients. The Federal Institute for Drugs and Medical Devices (BfArM) denied the subsequent authorization in its decision of 17 June 2016, whereupon the plaintiff filed an action with the Cologne Administrative Court. The plaintiff justified the subsequent authorization pursuant to Sec. 105 para. 4c AMG on the grounds that the homeopathic medicinal product had already been authorized in Austria and the Czech Republic. Previously, the plaintiff had been given two deadlines to rectify the defects and had already been refused subsequent authorization in 2005. The BfArM argued that the plaintiff had not provided proof of the suitability of the excipients used, which were not contained in the Homeopathic Pharmacopoeia (HAB), in accordance with the European Pharmacopoeia (Ph.Eur.). This requires confirmation that the homeopathic properties and active ingredients are in no way impaired or altered by the excipients used. The Cologne Administrative Court dismissed the action on 14 May 2019 on the grounds that a claim for subsequent authorization pursuant to Sec. 105 para. 4f AMG was precluded by the grounds for refusal in Sec. 25 para. 2 sentence 1 nos. 1, 2, 3, 4 alt. 2 and 5a AMG.
The plaintiff appealed against the judgment. However, the Higher Administrative Court of Münster dismissed the appeal on 29 November 2022 (case reference: 9 A 2428/19) and ruled that the plaintiff was not entitled to subsequent authorization for the medicinal products. The plaintiff is not entitled to subsequent authorization in accordance with Sec. 105 para. 4c AMG, as the recognition procedure does not apply to homeopathic medicinal products within the meaning of Art. 16 para. 2 Directive 2001/83/EC. The recognition procedure is intended to ensure the harmonization of national authorization decisions in the European Union. However, it is not intended to apply to homeopathic medicinal products. The intention of the legislator is expressed in Sec. 25b para. 6 AMG. The reason for this is that according to Art. 16 para. 2 of Directive 2001/83/EC, the Member States are authorized to introduce special provisions in their respective territories in accordance with the principles and special characteristics of homeopathic medicine. This means that each Member State has its own authorization regime so that the equivalence of authorization decisions is no longer guaranteed. Sec. 105 para. 4c AMG is therefore interpreted restrictively to the effect that the provision does not apply to homeopathic medicinal products within the meaning of Art. 16 para. 2 Directive 2001/83/EC. Since only the German authorization regime is to be applied, the grounds for refusal of Sec. 25 para. 2 sentence 1 no. 4 alt. 2 AMG because the monographs of Commission D cannot be used as evidence of therapeutic efficacy. This is only possible if the product was manufactured in accordance with the HAB and proof of the suitability of added excipients in accordance with the Ph. Eur. specifications was not provided. As a result, the grounds for refusal according to Sec. 25 para. 2 sentence 1 no. 1 and no. 3 alt. 1 AMG are present.
Co-Author: My Anh Cao
