Locations
LEGISLATION | Royal Decree regulating in vitro diagnostic medical devices
Last week, Royal Decree 942/2025 of 21 October, regulating in vitro diagnostic medical devices, was published in the Official State Gazette (BOE).
The published regulation, which is already in force, repeals the previous regulation contained in Royal Decree 1662/2000, except for certain specific provisions, and specifies issues such as the determination of the competent authority for the purposes of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, the health guarantees of in vitro diagnostic products, the establishment of the language regime and the regulation of procedures for the manufacture of products for use in the healthcare centre itself.
ADVERTISEMENT | Practical guide for reviewing materials published by the Government of Catalonia
This month, the “Generalitat de Catalunya” published a practical monograph on the review of promotional materials for medicines. The aim of this guide is to provide a practical support tool that facilitates excellence in the review of these materials and helps to identify any critical issues they may present.
The guide lists and describes the steps and issues to be taken into account for proper review and also includes a checklist to facilitate monitoring and compliance with the guide.
The use of this guide seeks to ensure that the advertising of medicines is carried out in accordance with the law and in an ethical, transparent and useful manner for clinical practice.
The practical guide is available on the website of the Generalitat de Catalunya (Catalan Regional Government) in the section on monographs relating to the promotion and advertising of medicines.
Pharmaceutical law course organised by CEFI
Last week, the Pharmaceutical Law Course organised by the Centre for the Promotion of Research (CEFI) was held in Madrid.
Of particular note was the participation of Javier Padilla, Secretary of State for Health, who announced that the final text of the Royal Decree regulating the evaluation of health technologies will be published shortly. According to him, this text includes key elements such as transparency in processes, predictability and patient participation. The other relevant text, which is still being processed and for which no approximate publication date is available, is the reform of the Law on Medicines and Health Products.
The course was also attended by César Hernández, Director General of Common Services Portfolio of the SNS and Pharmacy, who addressed the reform of the Law on Medicines and Health Products and provided information on relevant issues such as the inclusion of a dynamic pricing system, instead of a selected pricing system, or the existence of a 90-day period for the accelerated, conditional and/or provisional incorporation of new medicines or new indications for already funded medicines.
LEGISLATION | Digital Health Law
The deadline for submitting comments to the public consultation on the Draft Digital Health Law expired on 20 October. It should be noted that the purpose of the bill is to adapt Spanish law to the European Health Data Space Regulation, and its objective is to regulate the use of digital and emerging technologies in the healthcare sector, as well as the ethical and secure processing of clinical data for scientific purposes.
LEGISLATION | 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 published the 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.
This update responds to the need to address the changing challenges posed by illicit drug trafficking and consumption, and seeks to improve control over the circulation of these substances.
The deadline for submitting comments is 13 November.