Locations
CLINICAL TRIALS | Guide to excellence in conducting clinical trials in hospital pharmacies
On 30 September, we had the opportunity to attend the presentation of the Guide to Excellence for Conducting Clinical Trials in Hospital Pharmacy, promoted by the Spanish Society of Hospital Pharmacy (SEFH) and Farmaindustria. During the event, the new version of the guide was presented, updating the previous guide presented in 2022, in which it was necessary to include issues of great relevance.
This update includes new sections and appendices relating to all stages of clinical trials in hospital pharmacy services, focusing on aspects such as digitisation and the use of platforms, elements of decentralisation applied to pharmacy services, and the importance of the environment and sustainability in relation to the work carried out by hospital pharmacy services during the course of a clinical trial.
LEGISLATION | Draft Order amending Order SCB/45/2019, of 22 January, amending Annex VI to Royal Decree 1030/2006, of 15 September, establishing the portfolio of common services of the National Health System and the procedure for updating it, regulating the procedure for the inclusion, alteration and exclusion of orthopaedic products and determining the correction coefficients
On 30 September, the Ministry of Health published for public consultation and information the Draft Order amending Order SCB/45/2019, of 22 January, which amends Annex VI of Royal Decree 1030/2006, of 15 September, which establishes the portfolio of common services of the National Health System and the procedure for updating it, regulates the procedure for the inclusion, alteration and exclusion of orthopaedic products, and determines the correction coefficients.
The text aims to implement the proposals agreed by the Interterritorial Council of the National Health System regarding the amendment of Order SCB/45/2019, of 22 January, corresponding to the consideration of the UDI of products, regulated by Regulation (EU) 2017/745 and the REF in the case of spare parts and accessories not considered medical devices, as an additional system for the identification of financed products, the renewal of the range of orthopaedic products and the implementation of the range by sections.
The deadline for contributions expires on 21 October 2025.
LEGISLATION | Draft Order updating Annexes I, II and III of Royal Decree 1207/2006, of 20 October, regulating the management of the Health Cohesion Fund.
On 2 October, the Ministry of Health published for public consultation and information the Draft Order updating Annexes I, II and III of Royal Decree 1207/2006 of 20 October, which regulates the management of the Health Cohesion Fund.
The purpose of the update is to ensure that the annexes affecting the Health Cohesion Fund are up to date and serve as a clear and predictable list of which processes are eligible for referral between autonomous communities.
The deadline for contributions expires on 22 October 2025.
Reminder from the AEMPS regarding the use of the electronic form to process variations to medicinal products for human use authorised by non-centralised procedure
The Spanish Agency of Medicines and Medical Devices (AEMPS) reminds users that, as of 29 September 2025, it is highly recommended to use the electronic form (eAF) in its web version for processing all variations to medicinal products for human use authorised by non-centralised procedure (non-CAP), whenever technically feasible, as already indicated in the information note published on 27 June, issued in accordance with the recommendation of the European Medicines Agency (EMA).