Objectives Difference between drugs for dermal use and drugs that are intended for other routes of administration is that the selection of excipients depends on whether the goal is to achieve a systemic or local effect. In drugs for dermal use bioavailability of the active substance depends on its physical-chemical properties, pharmaceutical-technological features of the preparation, production process and way the drug is administered by a patient. The aim of this paper is to describe biopharmaceutical peculiarities of drugs for dermal use and contribute to the understanding of guidelines for preparation of documentation for marketing authorisation laid down by the European Medicines Agency (EMA), which are related to drug development, production, quality control and stability testing. Materials and methods Literature search was done by topic and subject of research, authors and journals, from general to specialized articles and guidelines relevant for the problem of the final paper. During literature search and collection of relevant data, on-line databases were used (PubMed, ScienceDirect, medicinal products database of the Agency for Medicinal Products and Medical Devices). Results Over the past 60 years topical delivery of drugs has become much more widely understood and much more is now known about the disposition of drugs in the skin. Today, different dermatological vehicles that are tailored to patients’ needs are produced. Additionally, better is appreciated how the formulation may affect rates of drug delivery, and ultimately, its efficacy and safety. On the market numerous systems for dermal use are available, but they are restricted to specific active substances. Further progress in the development of drugs for dermal use depends on the possibilities of overcoming the problems associated with the permeability of the skin and the skin irritation caused by the active substance and/or excipients. The development of new technologies that would increase the permeability and reduce skin irritation, would allow the use of hydrophilic molecules, macromolecules and conventional active ingredients for new therapeutic indications in preparations for dermal use. Conclusion Drugs for dermal use are big challenge for drug manufacturers due to the skin barrier whose primary role is to protect the body from external influences. Therefore, knowledge of the structure and function of the skin is crucial in the development of drugs for dermal use. Development of these drugs is based on the adjustment of transmission through the skin by choosing appropriate vehicles and on the use of modern pharmaceutical forms for dermal use (nanosystems). Application for granting marketing authorisation for drugs for dermal use in EU can be submitted according to Article 8(3) of Directive 2001/83/EC (full dossier) or according to Article 10(3) of Directive 2001/83/EC (hybrid application). In generic drug development, main strategy is „copying“ of qualitative and quantitative composition of reference product and greatest challenge is demonstration of therapeutic equivalence.