The position paper underscores that this law should be seen not merely as a formal EU alignment obligation, but as a meaningful opportunity to modernize the system, improve efficiency, and ensure timely and sustainable patient access to quality, safe, and effective medicines, with full and consistent transposition of EU law serving as the guiding principle throughout. Through a comprehensive set of recommendations focused on simplifying and digitalizing procedures, reducing administrative burdens, improving legal clarity, and building greater predictability and transparency, AmCham remains a committed partner to the Ministry of Health in advancing a modern, efficient, and investment-friendly regulatory environment for the pharmaceutical sector.
