Cross-border activities. Pharmaceutical sector

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. Article 72 refers to imports  and Article 73 to exports.

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.

Export/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. 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.

Circular 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.

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.

More information about imports and exports of medicines in Foreign Trade

Access the AEMPS website

To import healthcare products in Spain, an importer operating licence is required. See information on: Starting up, managing and closing a business. Registration, change of legal form, or closure of a business .

Healthcare product facilities

The following companies/activities require an operating licence:

• Mass manufacturers
• Custom manufacturers
• Consolidators
• Sterilisers for third parties
• Importers

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 pharmaceutical inspectorate at customs verifies that:

• Products comply with the requirements established in applicable European legislation and;
• The importer has an operating licence.

For this verification, the following checks can be conducted:

• A document check.
• Identity and physical checks of products for issuing a fit-for-purpose certificate.
• Rejection of products.

When products arrive:

• Importers of healthcare products must request an inspection by the pharmaceutical inspectorate through the online SIFAEX   application, called DOIFE.
• 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.

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.

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.

In the case of cosmetic products:

The border pharmaceutical inspectorate will verify that the importing company has submitted the following to the AEMPS:

• A self-declaration of cosmetic products importing activities.
• A declaration stating that the cosmetic products have a person who is responsible for marketing in the European Union.

In the case of personal care products:

The border pharmaceutical inspectorate will verify that the importing company has submitted the following to the AEMPS:

• A self-declaration of personal care products importing activities.
• A declaration stating that the products have a marketing authorisation and registration in force granted by the AEMPS.

In the case of biocides:

The pharmaceutical inspectorate at the border will verify:

• That the importing company holds current authorisation for biocide importing activities granted by the AEMPS.
• That the product has a marketing authorisation and registration in force granted by the AEMPS.

The preceding importers must request an inspection by the pharmaceutical inspectorate at the border.

The request is submitted through the SIFAEX  online application. All requested data must be completed, and the pertinent documentation must be attached, in the case of cosmetics. SIFAEX is connected to the IT application of the self-declaration, COSMET2. 

In turn, SIFAEX is automatically connected to the application of the customs authorities in order to continue with the corresponding customs procedure.