Caution regarding voluntary statements on medicinal product packaging, package leaflets and summary of product characteristics

The Federal Administrative Court (BVerwG) ruled on10 October 2024 (Az. 3 C 29.22)on the permissibility of certain voluntary statements on medicinal product packaging, package leaflets and summaries of product characteristics.

The claimant pharmaceutical undertaking had advertised the statements "alcohol-free" and "sugar-free" on a cough syrup. This was objected to by the competent authority.

Key points of the judgment:

1. Permissibility of voluntary statements under the Medicinal Products Act (AMG)

Voluntary statements are only permitted if they are related to the use of the medicinal product, are important for health education of patients and do not contradict the mandatory statutory information (§ 10 Abs. 1 Satz 5 AMG, § 11 Abs. 1 Satz 7 AMG).

The disputed statements do not meet these requirements because they have no safety-ensuring function and do not contribute to proper use of the medicinal product.

2. "Alcohol-free" and "sugar-free"

The statement "alcohol-free" is impermissible because the cough syrup contains small amounts of ethanol (1.32 mg per dose). This contradicts an absolute formulation such as "alcohol-free".

"Sugar-free" is likewise impermissible. This statement says nothing about the actual sugar content, which would however be material for patients.

3. Systematic nature of mandatory information

Statutory information on ingredients is sufficient to adequately inform patients. Additional "without"-statements can cause confusion, particularly if they are not formulated completely or are misleading.

4. Summary of product characteristics

The statement "alcohol-free" is also impermissible in the summary of product characteristics. This information is neither relevant to the use of the medicinal product nor factually correct. Healthcare professionals can rely on the completeness of the statutory mandatory information.

5. Principle of equal treatment (Art. 3 Abs. 1 GG)

The prohibition of the statements does not constitute unequal treatment because the regulations apply uniformly to herbal and chemical medicinal products.

Recommendation

The judgment makes clear that voluntary statements on medicinal product packaging and in medicinal product information are subject to strict standards in order to avoid misleading and unsettling patients. Pharmaceutical undertakings should formulate the mandatory information in such a way that these requirements are met. In case of doubt, the mandatory information should belegally and technically reviewedin order to avoid legal disputes and litigation.