In brief On 26 June 2023, the Spanish National Court annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (“ITPs”) set up by the Spanish Ministry of Health in 2020 (“Plan”). The Court based its decision on the grounds that (1) the system was created without following the legal procedure, and (2) was approved by a body that did not have the authority to do so. The Court concludes that…
In brief Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on March 22. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kinds of products and introduces provisions regarding the manufacture of in-house products and the reprocessing of single-use products, among other significant changes. In more detail The new…
In brief The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by…