Locations
Reduction of problems concerning shortage of medicines
On 25 February, the Spanish Agency of Medicines and Medical Devices (AEMPS) published the report on supply problems for the second half of 2024, which shows a 12.7% decrease in supply problems compared to the previous year. The report especially highlights the drop in the number of supply problems with respect to anti-infective medicines, as a result of the preventive actions implemented by the AEMPS.
This decrease is due to the joint work carried out by health professionals, laboratories and the administration, and has been intensified thanks to the implementation of actions by the AEMPS to mitigate or minimise these problems, including export stoppages.
Pilot coordinated assessment of clinical investigations and performance studies
The European Commission has announced the launch of a pilot coordinated evaluation of clinical investigations and performance studies in several Member States. Spain is among the Member States interested in participating in this evaluation.
This assessment will allow sponsors to submit a single application for coordinated pilot assessments, and would bring the following benefits:
• Unified engagement
• More transparency and harmonisation
• Simplified requests for information
• Consistency across Member States
• Document management efficiency
• Simplified management of substantial modifications
• Faster overall process
Sponsors interested in participating in the coordinated pilot evaluation for medical devices should complete the expression of interest form (available on the European Commission's website) and send it by email by 30 June 2025.
The call for in vitro diagnostic medical devices will be opened at a later stage.
BIOCIDES | Draft Royal Decree regulating the registration and conditions for the authorisation, manufacture, marketing and use of biocidal products
On 21 February, the Ministry of Health opened a public hearing and information period for the submission of contributions to the draft Royal Decree regulating the registration and conditions for the authorisation, manufacture, marketing and use of biocidal products.
The aim of this Royal Decree is to regulate:
• Specific conditions for the authorisation, manufacture, packaging, storage, placing on the market and use of biocidal products in the national territory.
• The operation of the Official Register of Biocidal Products.
• Training to carry out treatments with biocidal products.
• The establishment of the competences derived from the application at national level of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the placing on the market and use of biocidal products (hereinafter, the Biocidal Products Regulation).
• The system of infringements and penalties applicable for non-compliance with the provisions of the Biocidal Products Regulation and this Royal Decree.
• The transitional provisions governing the national procedures in force during the periods established in Article 89 of the Biocidal Products Regulation.
The deadline for submissions expires on 13 March.
New website with information on blood-derived medicines
Last February, the Spanish Agency of Medicines and Medical Devices (AEMPS) launched a new website on blood-derived medicines.
The site provides information on this type of biological medicine and gives some examples, as well as specific information on:
(a) Applicable legislation.
(b) Safety of blood-derived medicinal products.
(c) PMF (Plasma Master File) certification.
(d) Batch release.