Medicinal products for human use 2020/06/05
Joined cases C‑101/19 and C‑102/19 (Deutsche Homöopathie-Union (DHU) Arzneimittel GmbH & Co. KG v Bundesrepublik Deutschland)
Judgement of the Eighth Chamber
23 April 2020
The Court of Justice of the European Union prohibited the inclusion of additional information in the package leaflet of medicinal products other than that listed in Article 69 of Directive 2001/83/EC of the European Parliament and of the Council relating to the human use of medicinal products. In particular, the CJEU opposed the inclusion of instructions concerning the dosage schedules for homeopathic medicinal products in the package leaflets of these products.
The dispute concerned the interpretation of Articles 62 and 69 of Directive 2001/83/EC on the human use of medicinal products: Are the provisions listed in Article 69 concerning the content of the package leaflet of medicinal products exhaustive, or may the leaflet contain other information, such as instructions relating to the posology of homeopathic medicinal products? Besides, since Article 62 of the Directive allows the inclusion of additional information that is useful for the patient, the applicant also raised the question of whether such dosage instructions constitute useful information for the patient.
The German Homeopathic Union (Deutsche Homäopathie-Union, “DHU”) applied for the registration of two homeopathic medicinal products in the form of a cream. The package leaflets provided instructions for the consumer to apply the cream to the skin once to twice a day.
The Federal Institute for Medicines and Medical Devices in Germany (Bundesinstitut für Arzneimittel und Medizinprodukte) refused to register the products and requested the dosage instructions to be removed from the package leaflets of the products. The DHU then lodged an appeal, which was dismissed by both the Administrative Court of Cologne and the Court of Appeal (Oberverwaltungsgericht). The German Constitutional Court (Bundesverfassungsgericht) stayed the proceedings and referred the above-mentioned question to the European Court of Justice (ECJ).
In its judgment, the ECJ prohibited the inclusion of any information other than that listed in Article 69 in the package leaflets of the medicinal products concerned and opposed the inclusion of instructions concerning the dosage of homeopathic medicinal products.
According to the Court, the prohibition of additional information is essential in order to maintain a clear and certain distinction between homeopathic medicinal products and traditional medicines. The Court pointed out that the medicinal products in question are subject to a special, simplified registration procedure, whereas other medicinal products require a marketing authorisation as well as stricter and precise instructions relating to their use. Allowing the package leaflet to include information other than that listed in Article 69 could render the distinction ambiguous and pose risks for consumers. In addition, the Court ruled that the argument according to which information which is useful to the user may be added to the packaging leaflet as provided by Article 62 does not apply to matters relating to homeopathic medicines.