: For specialized fields like radiopharmacy, the requirements for a Qualified Person under RD 824/2010 align with conventional pharmaceutical standards, requiring specific university-level expertise and practical experience. Regulatory Oversight and Inspection
: This role carries significant responsibility, ensuring that only safe and effective products enter the market. rd 824/2010
: The Director Técnico must personally certify that every batch of medicine produced or imported complies with both the RD 824/2010 standards and the specific marketing authorization. The decree has been updated and complemented by
The decree has been updated and complemented by later regulations, especially Law 18/2022 on the creation and growth of companies (Crea y Crece Law), which mandates electronic invoicing for all companies and self-employed professionals in B2B transactions starting from specific phases (2024–2026), and by Law 56/2007 on measures to promote the information society (LISI). : For specialized fields like radiopharmacy