Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov

This legislation establishes the legal framework for the regulation of medicinal products and medical devices in Slovakia. It ensures that healthcare products are safe, effective, and high-quality before they reach patients, while regulating their distribution and sale. This act affects pharmaceutical companies, medical device manufacturers, healthcare providers, and pharmacists. It sets the rules for product registration, clinical trials, and the monitoring of adverse effects.