Royal Decree 477/2014

Real Decreto 477/2014

On 14 June 2014, the Official Spanish Gazette issued Royal Decree 477/2014, governing the requirements and guarantees that Advanced Therapy medicinal products that have not been industrially manufactured must meet in order to be granted the applicable authorisation for use by the Spanish Agency of Medicines and Medical Devices, and establishing the traceability and pharmacovigilance standards of these medicinal products once authorised. The document is extremely relevant as the regulations outlined are mandatory. The PDF can be downloaded from this website.