Locations
The preliminary draft of the Tobacco Law has been approved
On 9 September, the Ministry of Health released for public consultation and information the draft law amending Law 28/2005 of 26 December on health measures against smoking and regulating the sale, supply, consumption and advertising of tobacco products.
This proposal introduces new measures aimed at strengthening prevention, protecting the most vulnerable groups—with special attention to young people—and providing a clearer legal framework for the emergence of new tobacco-related products that, until now, had no specific regulation.
It includes new prohibitions:
- Prohibition of the consumption of tobacco and related products by minors, and extension of the protection that until now was limited to sale or delivery.
- Prohibition of the sale and supply of single-use electronic cigarettes.
- Extension of the areas where smoking is prohibited and incorporation of new collective use environments, both indoors and outdoors, in line with the recommendations of the European Commission, including:
- Outside health, educational, university and social centres.
- Children's playgrounds and cultural or sports areas.
- Bar terraces, transport stations, outdoor shows and concerts.
- Transport vehicles with drivers.
The text also substantially modifies the regime applicable to the advertising, promotion and sponsorship of tobacco products and related products.
The deadline for submitting applications expires on 30 September 2025.
Framework agreement for the AMAT-I 2025 Plan to renew the Spanish National Health System's high-tech healthcare equipment
The Council of Ministers approves the first framework agreement within the 2025 High-Tech Healthcare Equipment Acquisition Plan (AMAT-I Plan 2025). The tender is aimed at purchasing neonatal equipment for participating administrations, including eleven autonomous communities, the Ministry of Defence and INGESA centres located in Ceuta and Melilla.
This framework agreement will have an initial duration of three years, during which time the acquisition of around 650 devices is planned with the aim of renewing and expanding the technological equipment of the National Health System (SNS), incorporating criteria of economic efficiency and environmental sustainability.
Draft Law on Patient Organisations
On 5 September, the Ministry of Health submitted the Draft Bill on Patient Organisations for public consultation.
The proposal aims to (a) grant patient organisations legal status, (b) establish the rights and obligations of patient organisations, and their areas of participation and co-governance, and (c) facilitate the creation of a register of patient organisations.
The deadline for submitting applications expires on 23 September 2025.
CLINICAL TRIALS | Extension of the accelerated assessment procedure in early-phase trials
The Spanish Agency of Medicines and Medical Devices (AEMPS) is extending its accelerated assessment procedure in early-phase trials. This accelerated assessment will apply to all national phase 1 trials in oncology and rare diseases investigating a biological medicine.
Applications submitted by sponsors through the Clinical Trial Information System (CTIS) will be validated and evaluated within 26 days instead of the usual 45 days.
To qualify for this procedure, interested sponsors must contact the AEMPS before submitting their application by sending an email.
New edition of the list of essential medicines published by the WHO
Last week, the World Health Organisation (WHO) published a new updated edition of its list of essential medicines for both adults and children.
See the lists here:
https://iris.who.int/bitstream/handle/10665/382243/B09474-eng.pdf
https://iris.who.int/bitstream/handle/10665/382242/B09475-eng.pdf