- Due to the health situation caused by SARS-CoV-2, the AEMPS has issued extraordinary authorizations for the import of health products to cover the needs.
- Currently, the demand for these products is stabilizing, so it is important to prioritize the usual procedure for importing them, with a series of mandatory compliance requirements.
- Companies that have carried out import activities of health products or in vitro diagnostic health products must guarantee their traceability through documented registration.
The health crisis caused by SARS-CoV-2 has generated in the spanish market a much higher than usual demand for certain health products such as surgical masks, gloves, in vitro diagnostic tests, thermometers, etc.
Many of these products have arrived through imports from third countries. The requirements for the import of health products in Spain are established in Royal Decree 1591/2009, of October 16, which regulates health products.
The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is responsible for verifying these requirements when the products are imported. This verification is done when the goods arrive at customs, through the control carried out by the inspection services of the functional areas of Health of the Government delegations.
According to the usual procedure, a number of requirements must be met in order to authorize the importation. The products must have the CE marking, have followed the corresponding conformity assessment procedure and that the importer has a prior operating license.
however, the AEMPS, for justified reasons, may authorize the importation of health products that do not meet any of these requirements. In this sense, the Agency issues extraordinary import authorizations in exceptional situations, after assessing the conditions in which the products will be imported, to guarantee their safety in use.
As a result of the health crisis caused by SARS-CoV-2 and to speed up the import of these health products and cover the needs, the Agency has issued extraordinary import authorizations to both companies and autonomous communities, as well as to the institutions that have requested it. Before entering Spain, these imports of health products are inspected at the border to verify that the imported goods correspond to those indicated in the AEMPS authorization.
Currently, the demand for these products in Spain is in a stabilization phase, therefore, it is necessary to return to the usual procedure for the import of health products.
Those entities that intend to import health products must apply for a prior operating license, through the IPS telematic application at the AEMPS electronic headquarters. That is why they have the INSTRUCTIONS PS 1/2019, which includes all the process and information necessary for the application and which can be found at the following link:
You can also turn to a company that already has a license to import health products and that can carry out all import activities. From the IPS application finder, located on the home screen, you can consult the list of these companies.
Finally, it must be borne in mind that companies that have carried out import activities of health products or in vitro diagnostic health products, must guarantee their traceability, having to have a documented record of the products in which the following data: product trade name, model, lot number, customer identification, date of shipment or supply.
Likewise, any adverse incident related to the products must be notified to the AEMPS as soon as it becomes known.
References
- Royal Decree 1591/2009, of October 16, which regulates health products.
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606 . - Royal Decree 1616/2009, of October 26, which regulates active implantable health products.
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17607 . - Royal Decree 1662/2000, of September 29, on health products for in vitro diagnosis.
https://www.boe.es/buscar/doc.php?id=BOE-A-2000-17597 .
News source: https://www.aemps.gob.es/
