Human, animal or synthetic biological material for research, human diagnosis or quality control; haematopoietic progenitor cells for analytical purposes; and environmental samples suspected of containing pathogenic agents for analysis or research.

Draft Royal Decree establishing health requirements for the import and export of biological material

The aim of the draft is to streamline the health control and authorisation procedures relating to the import and export of biological material, including in vitro diagnostic reagents, intended for biomedical research, human diagnosis or quality control, whilst ensuring the protection of public health through the application of requirements proportionate to the health risk posed by each type of material, without hindering international trade. To this end, the regulation establishes a classification of biological material according to the risk it may pose to public health, defining specific and proportionate requirements for each category.

The regulation also creates a nationwide information system enabling the electronic submission and processing of applications for the import and export of regulated biological material, as well as human substances intended for application in humans.
The draft brings its provisions into line with national and European Union regulations, consolidating into a single provision the regulatory framework governing health controls and the authorisation of imports and exports of biological material intended for biomedical research, human diagnosis or quality control. At the same time, it aims to streamline administrative procedures and enhance the effectiveness of control measures, ensuring the protection of public health without hindering the international trade in this type of material