SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
authorised through the mutual recognition procedure to address supply shortages. Additionally, the list includes vulnerable medici- nal products essential for national clinical practice. Products from the European List of Critical Medicinal Products that meet Spain’s national criteria are also considered, along with those that have a high market concentration (over 70% share) and are manufactured nationally. Medicinal products still under market pro- tection are excluded, as their availability is guaranteed through other mechanisms. There are no fast-track registration routes in place for medical devices. 4.2 Regulatory Reliance Spain embraces regulatory reliance, particularly with- in the European Medicines Regulatory Network. The AEMPS operates within the EMA-co-ordinated net- work, contributing to centralised and mutual recogni- tion procedures for MAs. Furthermore, the AEMPS adheres to the mutual rec- ognition agreements (MRAs) established between the EU and third-country authorities concerning good manufacturing practice (GMP) inspections and batch certification for human and veterinary medicinal prod- ucts. In this context, the AEMPS regularly publishes communications detailing the procedures to be fol- lowed in Spain in alignment with the MRAs. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Medicinal Products Any manufacturer or importer of medicinal products, and those involved in processes such as fractionation, packaging and presentation for sale, must be author- ised by the AEMPS (Article 63 of Royal Legislative Decree 1/2015). This authorisation is also required if the medicinal product is for export only. To obtain the authorisation, the manufacturer must:
• apply to the AEMPS through the website of the Spanish Agency for Medicines and Health Prod- ucts ( Agencia Española de Medicamentos y Productos Sanitarios LABOFAR), specifying the medicinal products and pharmaceutical forms to be manufactured or imported, as well as the location and facilities where the manufacturing or control will occur; • have suitable premises and technical and control equipment for the activity intended to be carried out; and • have a technical director, manufacturing manager and quality control manager with sufficient qualifi- cations. The AEMPS will verify that the application meets the formal requirements within ten days and conduct an inspection at the facilities. The AEMPS will then issue the authorisation resolution, notifying the autonomous regions. The maximum time for notification of the res- olution is 90 days from the receipt of the application. The authorisation is valid indefinitely, unless revoked. Medical Devices Companies engaged in the manufacture, importation, grouping or sterilisation of medical devices, as well as the facilities where these activities are carried out, require a prior operating licence from the AEMPS. The AEMPS will review the submitted application and notify its decision within three months from the application date. Operating licences might be refused, suspended or revoked if the documentation provided or inspection reports do not guarantee that the appro- priate facilities, means, procedures and personnel are in place. Operating licences are valid for a maximum of five years and may be renewed upon application by the interested party. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and
Medical Devices Medicinal Products
In Spain, the distribution of medicinal products can be carried out by entities holding a wholesale distri-
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