Spain
Main changes of the new pharmaceutical regulation
On Tuesday April 8th, the Council of Ministers gave the green light to the Draft Law on medicines and medical devices, which aims to modernise and significantly improve the regulatory framework in Spain. Once approved, the Draft Law will replace Royal Legislative Decree 1/2015, of July 24th, which approves the revised text of the Law on guarantees and rational use of medicines and health products.
On Wednesday 9th of April, the period for submitting observations opened, and will remain open until May 8th. This period allows the sector to analyze the new regulation and provide any comments they deem appropriate.
Our Life Sciences team analyzes the main changes of this new pharmaceutical regulation on this Legal Flash.