The price difference of medicinal products in the different European Union Member States has led to an increase in “parallel exports” originating from Spain. This has sometimes resulted in a lack of supply of certain medicinal products in the national market, causing public health concerns.
In view of this, the Spanish Agency of Medicines and Health Products (AEMPS) has issued Circular 2/2012, which establishes a statutory procedure for all intra-community exports concerning any medicinal products included in the updated list of medicinal products published on AEMPS’ website (List) (available at https://labofar.aemps.es/labofar/registroMedicamentos/consulta.do?metodo=detalleBusqueda
This List includes medicines which, according to the information available to AEMPS, can generate a lack of supply. The AEMPS will evaluate the inclusion of medicinal products in the List proposed by itself, by healthcare professionals and professional associations or by the health authorities of the Autonomous Communities. Reasons must be given to justify their being included in the List. The Circular does not apply to narcotic and psychotropic medicinal products.
As of 1 July 2012, the distribution warehouses and marketing authorisation holders and pharmaceutical laboratories (the latter upon request by AEMPS) are required to issue notifications of shipments of medical products included in the List.
Notifications shall be issued at least 3 working days before shipping the medicinal products. Several medicinal products may be included in one notification, if they have the same country of destination. The notifications must be made online and following the procedure described on AEMPS’ website. A template form is attached to the Circular as an annex.
Once the details required by AEMPS have been completed in order to send the notification, the issuer may print out a confirmation slip, which must be kept and made available to the health authorities for verification purposes if required.
If, as a result of a notification, supply problems are identified concerning a particular medicinal product, AEMPS will communicate this to the issuer of the notification within a period of 3 days and the issuer shall be instructed to cancel the shipment. In the event that AEMPS has instructed the issuer to cancel the shipment, AEMPS will immediately inform the Autonomous Community for further control.