Locations
Creation of an Action Platform to reform global health governance
Last week, Health Minister Mónica García announced during her participation in the forum ‘Spain in the Global Health Governance Model’ at the WHO Summit in Seville, the creation of an international Action Platform.
The initiative is intended as a starting point for building alliances between like-minded countries and strategic partners committed to fairer, more collaborative and efficient health governance. In this regard, Spain considers the following to be priorities:
- Ensure sustainable and predictable funding for the WHO.
- Clarify the mandates of international agencies.
- Establish effective coordination and accountability mechanisms.
- Open spaces for real dialogue between multilateral actors.
Draft Royal Decree establishing quality and safety criteria in radiodiagnostics
Last week, the Ministry of Health released for public consultation the Draft Royal Decree establishing quality and safety criteria for radiodiagnostics. The new standard seeks to establish appropriate quality and safety criteria in healthcare units where medical radiological procedures involving X-rays are performed, in accordance with the provisions of Directive 2013/59/Euratom and Royal Decree 601/2019.
The primary objective is to mitigate the increased risks to patients undergoing radiodiagnostic procedures resulting from the significant increase in the number of exposures and the introduction of new practices.
Deadline for submission of contributions: 11 July 2025
Lee la información completa aquí
Draft Order including new substances in Annex 1 of Royal Decree 2829/1977, of 6 October, regulating psychotropic substances and preparations, as well as the control and inspection of their manufacture, distribution, prescription and dispensing
Last week, the Ministry of Health released for public consultation the Draft Order adding new substances to Annex 1 of Royal Decree 2829/1977 of 6 October, regulating psychotropic substances and preparations, as well as the control and inspection of their manufacture, distribution, prescription and dispensing.
The objective of the amendment is a result of the changing situation following drug trafficking, making it necessary to update the lists with new substances to improve control over their circulation, as well as their prevention and repression.
Deadline for submission of contributions: 17 July 2025
Lee la información completa aquí
New Circular 1/2025 on foreign trade in medicines
Last week, the Spanish Agency of Medicines and Medical Devices (AEMPS) published the Circular 1/2025 on foreign trade in medicines, which is now applicable and replaces the current Circular 1/2015.
Although there have been no significant legislative changes, this new circular updates and clarifies certain relevant aspects. In particular, the main changes addressed are:
- The criterion for registered medicine is defined for the purposes of the circular.
- The pharmaceutical entities that may carry out each activity are clarified, distinguishing them from those that may submit applications to the AEMPS or make the corresponding notifications.
- The documentation that must accompany applications for authorisation to import, manufacture and export medicines not registered in Spain or intended for clinical trials not authorised in Spain and the certificates for export of these medicines to third countries are detailed.
- The validity of authorisations for the manufacture of unregistered medicines intended for third countries is amended.
- The validity of authorisations for the manufacture of unregistered medicines intended for other countries of the European Economic Area (EEA) is amended.
- The procedure for notifying the entry into Spain of medicines for human use from other Member States for export by wholesale warehouses is included.
- The procedure for authorising the export of medicines as humanitarian donations is included.
- The requirements for the purchase of medicines for the supply of first-aid kits for ships, yachts or aircraft are defined.
- The requirements applicable to medicines intended for the treatment of travellers are clarified.
- Aspects relating to active substances are included.
- Certain annexes are deleted.
Lee la información completa aquí