Royal Decree amending Royal Decree 1345/2007, of October 11, 2007, regulating the procedure for the authorization, registration and conditions of dispensing of industrially manufactured medicines for human use
Last week, the Ministry of Health submitted for public consultation and information the text of the draft Royal Decree amending Royal Decree 1345/2007 of 11 October, which regulates the procedure for authorising, registering and dispensing industrially manufactured medicines for human use.
The objectives of this amendment are to require distribution entities, or the laboratory holding the marketing authorisation, to verify the authenticity and integrity of safety features and deactivate the unique identifier when supplying medicines to certain entities, when requested to do so, as well as to clarify the functions of the SNSFarma Node.
The deadline for submissions expires on 30 June 2025.
Calendar for the processing of applications for marketing authorisation for medicinal products for human use under the national procedure
The Spanish Agency of Medicines and Medical Devices has announced the schedule for marketing authorisation applications for medicinal products for human use submitted under the national procedure, which will come into force on 1 November 2025.
The aim is to promote efficient processing that allows applicants to know in advance the deadlines for application from the submission of a valid application to the completion of the process.
Handling of applications for exclusivity certificates relating to vaccines, medicines not authorised in Spain and/or in exceptional circumstances
From 16 June 2025, both public and private entities wishing to process applications relating to vaccines, medicines not authorised in Spain and/or in exceptional circumstances, as well as any other that the Spanish Agency of Medicines and Medical Devices (AEMPS) may consider on a case-by-case basis, following assessment, must manage such applications through the application made available by the AEMPS on the website of the Register of Medicines for Human Use (RAEFAR).
EMA’s annual report 2024
Last week, the EMA published its 2024 annual report, which outlines the agency's strategic priorities and contributions to European public and animal health. The report summarises the highlights of human and veterinary medicines, together with key data.