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The import and the export of biological samples follows the Spanish Royal Decree 65/2006 promulgated on the 30th of January of 2006 and its enmend, the Order SAS SAS/3166/2009, enacted on the 16th of November, which substitutes the annexes of the previous royal decree.

In the Spanish territory it is considered an internal movement of biological sample and, thus, it does not require an authorisation.

In the Community Customs area an authorisation will not be required in order to import/export biological sample.

The biological sample catalogued as commercial do not need an express authorisation signed by the General Direction of the Public Heath, Quality and Innovation System, but the Annex I must be fulfilled, which will be signed by the external health inspector for their archive together with the commercial invoice of the product.

If products are exported/imported to other countries, this Royal Decree distinguishes the following procedures: 


PERIODIC EXPORT/IMPORT which approximately means once each term, may register in the Registro de Importadores y Exportadores of biological samples.  The requirements and the documentation may be consulted in the following link of the Spanish Ministry of Health, Consume and Social Welfare



The importer shall send an application to the General Direction of the Public Heath, Quality and Innovation System to the email:, together with the following documentation:

  • Health origin certification of the competent authority who identifies the package, its characteristics and the possible health risk if existing (Annex II)
  • An evidence written by the consignee assuming the responsibility of its adequate use and destruction (written model).
  • Accreditation for the activity of the importer/exporter: the importing organism shall have the necessary accreditations in order to carry out their activity and to comply with the directives for occupational safety applicable to these products (in this case, the UV is an organisms enough accredited)
  • Fullfilled model (Annex IV)

These procedures shall be done in advance to the import in order to avoid the custom retention of the samples, since not every transport company manages this procedure.

If the sample arrives in the custom without having done this procedure, its transport becomes difficult and it shall be necessary to contract an external company to carry out this procedure by fulfilling the compulsory authorisations that they must give in order to accomplish the operation and the cost implied. 



The exporters shall send a declaration, in which the essential information to identify the sample and its destiny appears, to the General Direction of the Public Heath, Quality and Innovation System to this email:

If the health authority of destination demands a health origin certificate, it shall be requested to the General Direction of the Public Heath, Quality and Innovation System.