import and export of pharmaceutical products

Import and export of pharmaceutical products free#

A declaration stating that the cosmetic products have a person who is responsible for marketing in the European Union.A self-declaration of cosmetic products importing activities.The border pharmaceutical inspectorate will verify that the importing company has submitted the following to the AEMPS: In the import of cosmetic, personal care and biocide products in Spain coming from third countries, the controls and procedures provided for in Order SPI/2136/2011, of 19 July, are applicable. Volver arriba Cosmetic, personal care and biocide products This application is connected to the application of the customs authorities, such that the certificate issued by the pharmaceutical inspectorate reaches customs automatically in order to continue with the corresponding customs procedure. All requested data must be completed in that application, and the documents that support the CE marking of the products must be attached: EU declaration of conformity issued by the manufacturer and a certificate of CE marking issued by a notified body whenever applicable.Importers of healthcare products must request an inspection by the pharmaceutical inspectorate through the online SIFAEX application, called DOIFE.Identity and physical checks of products for issuing a fit-for-purpose certificate.Products comply with the requirements established in applicable European legislation and įor this verification, the following checks can be conducted:.The pharmaceutical inspectorate at customs verifies that: Imports of healthcare products are subject to checks by the pharmaceutical inspectorate at customs, as described in Ministerial Order SPI/2136/2011 of 19 July laying down the procedures for health checks at the border by the pharmaceutical inspectorate and regulating the computerised pharmaceutical inspection system for border health controls (SIFAEX). The following companies/activities require an operating licence: Registration, change of legal form, or closure of a business. See information on: Starting up, managing and closing a business. To import healthcare products in Spain, an importer operating licence is required. More information about imports and exports of medicines in Foreign Trade See Circular 1/2015, on the foreign trade of medicines, and Circular 2/2012, on the prior notification of shipments of medicines to other Member States.

Import and export of pharmaceutical products free#

In accordance with the Agreement on the European Economic Area (EEA), recognising the free movement of goods between the contracting parties, signed in Porto on 2 May 1992 between the Member States of the European Union and three countries (the Kingdom of Norway, the Republic of Iceland and the Principality of Liechtenstein), these countries have the same consideration as all other Member States.Ĭircular 1/2015 sets forth the procedures that must be completed for requesting authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) for imports/exports prior to international trade controls. The regulation of these healthcare guarantees for foreign trade in medicines is dealt with in Chapter VIII of Royal Decree 824/2010 of 25 June regulating pharmaceutical laboratories, manufacturers of active substances for pharmaceutical use and the foreign trade of medicines and investigational medicinal products, and establishing the conditions for the import, manufacturing and export of medicines for foreign trade.Įxport/import means the exit/entry of any goods from/to the customs territory of the European Union (EU), not the intra-community movement of medicines.

Article 72 refers to imports and Article 73 to exports.

Exports and imports of medicines and their active substances must comply with the provisions of Royal Legislative Decree 1/2015 of 24 July approving the recast text of the Law on guarantees and rational use of medicines and healthcare products.