Locations
TRANSPARENCY | The Ministry of Health starts publishing the financing reports on the inclusion of new medicines in the National Health System
In order to promote and strengthen transparency, last week the Ministry of Health began publishing the financing reports on the inclusion of new medicines in the National Health System (NHS).
These reports will provide a detailed overview of the new medicinal products to be included in the pharmaceutical provision and each medicinal product will include a fact sheet with the following information:
- Basic information on the medicinal product.
- Description of the evaluation and authorisation process of the medicinal product.
- Information on the decision of the Interministerial Committee on Medicines Prices (CIPM) regarding the financing of the medicinal product.
- Details of the specific criteria that have led to the inclusion of the medicinal product in the National Health System.
- Reference to the resolution issued by the Directorate General for the NHS Services Portfolio and Pharmacy, which formalises the inclusion of the medicinal product in the pharmaceutical provision.
These reports will be published after the finalisation of the financing and pricing procedures and will be available on the website of the Ministry of Health.
Critical Medicines Alliance Strategic Report
As part of its work to identify key challenges and make recommendations on possible courses of action to strengthen the supply of critical medicines in the EU to mitigate the effects of global medicines shortages, the Critical Medicines Alliance published last week a strategic report that identifies priorities for action and proposes solutions to address problems of dependency and weaknesses in medicines supply chains to ensure the supply of medicines considered most needed in the EU.
The content of this report provides the basis for structural change in EU industrial policy and the Alliance's recommendations are based on the following:
- Strengthening EU manufacturing capacity.
- Proposals to provide incentives and support measures to diversify production and strengthen international cooperation.
- Favouring EU sourcing and production.
LEGISLATION | Draft Royal Decree regulating the return and destruction of narcotic and psychotropic substances and narcotic drugs by pharmacy offices and services
Last March 4, the Ministry of Health published for hearing and public information the draft Royal Decree regulating the return and destruction of narcotic and psychotropic substances and narcotic drugs by pharmacy offices and services.
Due to the increase in recent years in the use therapeutic of narcotic drugs for the treatment of pain in patients who require it, the objective of the standard is to establish a framework that provides for the following aspects:
- The management of the destruction, by pharmacy offices and pharmaceutical services, of medicines and/or narcotic substances and psychotropic substances, when any of them are expired, deteriorated or subject to withdrawal from the market due to other circumstances.
- The return by patients of surplus treatment with psychotropic and narcotic substances and narcotic drugs.
The deadline for contributions expires on March 24, 2025.
LEGISLATION | Draft Order amending Annex II of Royal Decree 81/2014, of February 7, establishing rules to ensure cross-border healthcare, and amending Royal Decree 1718/2010, of December 17, on medical prescriptions and dispensing orders
Last March 4, the Ministry of Health published for hearing and public information the draft Order amending Annex II of Royal Decree 81/2014, of February 7, establishing rules to ensure cross-border healthcare, and amending Royal Decree 1718/2010, of December 17, on medical prescriptions and dispensing orders.
The text of the Order updates Annex II of healthcare benefits subject to prior authorization of Royal Decree 81/2014, of 7 February, in accordance with current technical advances and scientific knowledge. In this sense, the list in Annex II is updated with a series of procedures, techniques and technologies included in the healthcare of common portfolio of services of the National Health System that have been selected because they require the use of highly specialized and costly medical equipment or medical infrastructures, among which are advanced therapy drugs and medical robotic systems.
LEGISLATION | Draft Order establishing the procedure and sanitary certification for the export of food and food products of non-animal origin
Last Friday, the Ministry of Health opened for public consultation the draft Order establishing the procedure and health certification for the export of food and food products of non-animal origin.
The draft Order has the following objectives:
- Articulate the procedure for certification of public health and food safety requirements applicable to food products of non-animal origin intended for human consumption and use for export to third countries.
- Establish an information system for the management of the application and issuance of sanitary certificates for the export of food products of non-animal origin for human consumption and use.
Through the implementation of these objectives, it is intended to reduce and simplify the administrative burden involved in the use of handwritten export health certificates, facilitate the issuance of certificates by electronic means, have a comprehensive management system that allows to know and provide at all times the information related to exports of food products of non-animal origin and facilitate the process of diplomatic legalization of health certificates when required by third party countries.
The deadline for contributions expires on March 24, 2025.
LEGISLATION | Draft Order regulating the sanitary requirements and controls on certain products imported or exported to third countries or territories
Last Friday, the Ministry of Health opened for public consultation the draft Order regulating the sanitary requirements and controls on certain products imported or exported to third countries or territories.
The text has the following objectives:
- To regulate the procedure and public health requirements for the importation and exportation of certain human products and goods susceptible to endanger public health.
- To regulate public health requirements and sanitary controls on the importation of products for human consumption or use in Ceuta and Melilla.
- Establishment of clear criteria for the exception of sanitary controls.
The deadline for contributions is March 24, 2025.
CLINICAL TRIALS | EMA publishes new clinical trial map
On March 3, the European Medicines Agency (EMA) published a clinical trials map available on the CTIS website, designed to help interested parties, especially patients, to locate clinical trials of interest in Europe in a simple and intuitive way.