SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
devices. In the exercise of its duties, the AEMPS has issued the following guidelines: • Circular 1/2015 on the foreign trade of medicinal products; and • Circular 2/2012 on the prior notification of shipments of medicinal products to other member states. Parallel imports of nationally authorised medici- nal products (ie, those which are distributed in Spain by an entity other than the MAH) are regu- lated by Royal Decree 1785/2000. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Medicinal Products 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 4.1 Requirement for Authorisation for Manufac- turing Plants of Pharmaceuticals and Medical Devices for more details. Medical Devices The importation of medical devices is subject to obtaining a prior licence from the AEMPS. Importers of medical devices established in Spain and class I or custom-made medical devices must be included in the registry of responsible persons. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Prior authorisation is required for the importa- tion of medicinal products into the EU customs territory, as established in Circular 1/2015. The duration of the import authorisation granted by the AEMPS depends on the type of medicinal
product. For finished medicinal products, inves- tigational medicinal products, those used in spe- cial situation programmes, advanced therapy medicinal products and hemoderivatives, import authorisations are valid for one year and may be carried out in several dispatches. 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 Euro- pean legislation, and that the importer has an operating licence. Ministerial Order SPI/2136/2011 lays down the procedures for health control at the border by the Pharmaceutical Inspectorate and regulates the computerised pharmaceutical inspection sys- tem 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, accord- ing to Council Regulation (EEC) No 2658/87. 7.5 Trade Blocs and Free Trade Agreements The import authorisation referred to in 6.2 Importer of Record of Pharmaceuticals and Medical Devices is not required if the prod- uct originates from another EU country (intra- community trade), or from Norway, Iceland or Liechtenstein, by virtue of the agreement for the European Economic Area (EEA) recognising the free movement of goods between the contract- ing parties, signed in Porto on 2 May 1992. In this case, a distribution licence is sufficient. For more information on distribution requirements, please see 5.1 Wholesale of Pharmaceuticals and Medical Devices .
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