Publication date: February 19, 2025

Introduction: The ambivalence of the issue and the regulatory context

The issue of informing the patient about the drug is of key importance in the treatment process, because the proper provision of information can affect the effectiveness of the therapy, patient safety and minimizing the risk of adverse effects. From a regulatory perspective, the rules regarding drug leaflets are precisely defined in both national and EU legal acts, but in practice we encounter differences in the formulation of this information by manufacturers, even in relation to products intended for the treatment of the same condition.

A comparative analysis based on the example of the comparative leaflets of two sample drugs, Maxitrol and Floxal – two preparations used in the treatment of blepharitis, although differing in composition and mechanism of action – reveals a certain editorial freedom of the manufacturers in shaping the content of the leaflets.

On the one hand, the law regulates in detail the requirements for the content of leaflets, on the other hand, there is flexibility in their formulation, especially in stylistic and organizational matters. The aim of this report is to provide an in-depth analysis of the legal provisions regulating this issue, as well as to present a comparison of two leaflets, taking into account both their substantive content and form.

Report objectives:

• Understand the laws that govern prescription drug information leaflets.
• Analysis of the details of the presentation of active substances, dosage, contraindications, etc.
• An assessment of the extent to which the drug manufacturer has freedom to edit such information and what the legal consequences of these choices are.

Legal Basis for Prescription Drug Disclosure Obligations

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