SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
6.2 Different Classifications Applicable to Pharmaceuticals Concerning the importer of record of pharmaceuticals and medical devices, please see 1.3 Difference Cat - egories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The importation and exportation of medicinal prod- ucts and medical devices is governed by Royal Leg- islative Decree 1/2015 (in particular, Articles 72 and 73, relating to exports) and Royal Decree 824/2010. The AEMPS applies and enforces regulations regard- ing the import, export and intra-community trade of medicinal products and medical devices. In the exer- cise of its duties, the AEMPS has issued the following guidelines: • Circular 1/2025 on the foreign trade of medicinal products; and • Circular 2/2012 on the prior notification of ship- ments of medicinal products to other member states. Parallel imports of nationally authorised medicinal products (ie, those which are distributed in Spain by an entity other than the MAH) are regulated by Royal Decree 1785/2000. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Medicinal Products The importation of finished medicinal products, inter- mediates or bulk products from third countries may only be carried out by a duly authorised pharmaceuti- cal importing laboratory. In addition, the importation itself is subject to prior authorisation by the AEMPS. Any individual or legal entity can apply for an import licence from the AEMPS if it complies with Article 63 of Royal Legislative Decree 1/2015. Requirements to obtain the import licence are the same as those listed for the application for manufacturing authorisations – please see 5.1 Requirement for Authorisation for
Manufacturing Plants of Pharmaceuticals and Medi- cal Devices for more details. Medical Devices Any natural or legal person engaged in the importation of medical devices, as well as the facilities where such activities are carried out, must obtain a prior operat- ing licence. This licence is granted by the AEMPS. The requirements for obtaining such licence are set out in Article 8 of Royal Decree 192/2023 for medical devices and in Article 8 of Royal Decree 942/2025 for in vitro devices. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Prior authorisation is required for the importation of medicinal products into the EU customs territory, as established in Circular 2/2015. When it comes to medical devices, no prior authori- sation is required for each individual importation. Instead, the importer and its facilities must hold a valid prior operating licence granted by the AEMPS, and the authorities will verify that the device complies with the applicable requirements, including CE marking and conformity assessment under the MDR and IVDR. Operating licences for both medical devices and in vitro diagnostic devices are valid for a maximum of five years. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Imports of healthcare products are controlled by the Pharmaceutical Inspectorate at customs, which will verify that the products comply with the requirements established in applicable European legislation, and that the importer has an operating licence. Ministerial Order SPI/2136/2011 lays down the pro- cedures for health control at the border by the Phar- maceutical Inspectorate and regulates the comput- erised pharmaceutical inspection system for border health controls. Annex I contains a non-exhaustive list of the headings subject to control. The products are classified according to the combined nomenclature (CN) code, according to Council Regulation (EEC) No 2658/87.
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