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Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is the national agency in Spain responsible to ensure the quality, safety, efficacy and correct information of the medicinal products and the medical devices along their lifecycle. With that aim, the Agency develops a wide range of activities, amongst which are the assessment and authorization of medicinal products for human or veterinary use, a continuous monitoring of safety, quality and efficacy of medicinal products in the market and those market surveillance activities falling under its competences.

AEMPS is well aware of the risk that counterfeit medicines pose to public health. In order to minimize the risks, the Agency has promoted a national strategy to combat fake medicines, now in its second edition, to reinforce the cooperation and the exchange of information among all stakeholders, public and private.

One of the elements of the national strategy is the development of an action plan against the illegal sales of medicinal products through the internet, acknowledged to be one of the channels by which counterfeit medicines could reach patients in Spain.

Another risk-reduction element foreseen in the national strategy is to raise awareness among patients about the risks associated with fake or illegal medicines. In this area, the AEMPS has launched awareness raising campaigns targeting the population prone to buy medicines through the internet.

As part of the legislative works associated with the European Directive 2011/62, the regulation of the sales at distance of medicinal products in Spain has been updated, with the enacting of specific regulation on the sale at a distance of medicinal products not subject to medical prescription by licensed pharmacies. This Decree establishes the requirements to be met by licensed pharmacies when selling medicines at a distance, ensuring an equivalent level of protection of public health as sales performed by physical pharmacies.

AEMPS also investigates and, if appropriate, takes actions against websites unlawfully intending to sell medicines to Spain. Cooperation with national (police, customs) and international partners is a key element in the fight against illegal trade of medicines over the internet.