SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes Fast-track registration routes are available for AEMPS-listed strategic medicinal products. While not explicitly established by law, these mechanisms have been implemented in practice by the AEMPS. The AEMPS regularly publishes and updates the strategic medicinal products list on its website, which includes medicinal prod- ucts that meet two key criteria: criticality (ie, importance of the therapeutic indication) and vulnerability (ie, availability of alternative treat- ments). The list of strategic medicinal products includes clinically essential but under-represented treat- ments in Spain, particularly those containing World Health Organization (WHO) essential active ingredients and those selected by the Food and Drug Administration (FDA). It also includes medicinal products for which cancel- lation or suspension requests have been denied due to their critical healthcare impact, as well as those authorised through the mutual recognition procedure to address supply shortages. Additionally, the list includes vulnerable medici- nal products essential for national clinical prac- tice. 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 protection 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 within the European Medicines Regulatory Net- work. The AEMPS operates within the EMA-co- ordinated network, contributing to centralised and mutual recognition procedures for MAs. Furthermore, the AEMPS adheres to the mutual recognition agreements (MRAs) established between the EU and third-country authorities concerning good manufacturing practice (GMP) inspections and batch certification for human and veterinary medicinal products. In this con- text, the AEMPS regularly publishes communi- cations detailing the procedures to be followed in Spain in alignment with the MRAs. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Medicinal Products Any manufacturer or importer of medicinal prod- ucts, and those involved in processes such as fractionation, packaging and presentation for sale, must be authorised by the AEMPS (Arti- cle 63 of Royal Legislative Decree 1/2015). This authorisation is also required if the medicinal product is for export only. To obtain the authori- sation, the manufacturer must: • apply to the AEMPS through the website of the Spanish Agency for Medicines and Health Products ( Agencia Española de Medicamen- tos y Productos Sanitarios LABOFAR), speci- fying the medicinal products and pharmaceu- tical forms to be manufactured or imported,
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