Locations
Update on the status of the Royal Decree on price and financing, the Medicines Law and the Royal Decree on Health Technology Assessment
Although the pharmaceutical industry's most eagerly awaited regulations have not yet been approved, the Ministry of Health expects to make progress on them by 2025.
With regard to the Royal Decree on price and financing, although the draft was put out for public consultation on 12 December, the Ministry hopes to have the final text and its approval this year, 2025.
As for the Medicines Law, it appears that it is awaiting submission to the Council of Ministers.
Finally, the Royal Decree on Health Technology Assessment is at a more advanced stage and is expected to be submitted to the Council of State soon.
Recommendations on ethical principles and conditions for the protection and welfare of animals
In compliance with the 5th additional provision of Law 7/2023, of 28 March, on the protection of animal rights and welfare, the Spanish Agency of Medicines and Medical Devices has drawn up a document of recommendations on ethical principles and conditions of animal protection and welfare, which must be respected in the conduct of veterinary clinical trials.
The aim of the document is to establish guidelines to ensure animal protection and welfare in the use of animals in clinical trials.
Automatic processing of the Hague Apostille in applications for the management of free sale certificates
With the aim of simplifying processes and reducing administrative burdens, the Spanish Agency of Medicines and Medical Devices has developed the automatic processing of the apostille of the Hague in the applications for the management of certificates of free sale (CLV) for medical devices, cosmetics, personal care products and biocides and export certificates (CEX) for medical devices.