Over-the-Counter (OTC) drug regulation in Romania: accessibility, safety and challenges

Emin CADAR

Faculty of Pharmacy, "Ovidius" University of Constanta

Cristina-Luiza ERIMIA

Faculty of Pharmacy, "Ovidius" University of Constanta

ABSTRACT

Over-the-counter (OTC) medications play a vital role in healthcare, allowing individuals to access treatments for minor ailments without a prescription. In Romania, OTC drugs are widely accessible and offer significant benefits to both consumers and the healthcare system by reducing the burden on medical professionals. However, ensuring the safety, quality, and responsible use of OTC medications remains a challenge, particularly given the risk of misuse and self-medication. This article explores the current regulatory framework for OTC drugs in Romania, assesses accessibility and safety issues, and identifies emerging challenges that require regulatory attention. Recommendations for policy improvements are provided to support a balanced approach to OTC...