Regulation and legislation
In order to improve patient safety and to regulate the production and use of PRP for non-transfusional use, the Spanish Agency for Medicines and Medical Devices (AEMPS) published two reports in May 2013 (2 – PRP-AEMPS and 3 – Resolucion-PRP-AEMPS) which are summarized below:
- PRP is classified as a non-industrially produced drug for use in humans.
- PRP may only be prescribed by physicians, dentists and podiatrists.
- PRP must be applied locally and used on the patient from whom it was obtained (autologous use).
- The procedure to obtain, process, store and apply PRP must be previously validated, and all material used must comply with CE regulations.
- The laboratory tests listed in Appendix 3 of 1 – RD 1088/2005 – BANCOS DE SANGRE must be performed in each process: serology for HIV, HBV, HCV and syphilis; genomic testing for HCV; blood type and Rh factor, irregular antibodies).
- Patients with an illness listed as a reason for exclusion in Appendix 2C of 1 – RD 1088/2005 – BLOOD BANKS are not eligible for this procedure. This includes patients with a history of hepatitis, HIV, severe heart disease or active bacterial infection.
In June 2015, the Spanish Agency for Medicines and Medical Devices (AEMPS) created a registry of healthcare facilities that perform “non-replacement therapeutic use of autologous plasma and its fractions”. The instructions to sign up for this registry can be found at: a href=”/wp-content/uploads/2023/05/8_AEMPS_altausuarios-PRP.pdf” target=”_blank” rel=”noopener”>8 – AEMPS-altausuarios-PRP
In July 2015, the Regional Department of Health of the Community of Madrid published several documents on the Quality Assurance levels required for the production of platelet-rich plasma (PRP), as well as on the requirements for PRP prescription and administration. The Regional Department of Health also announced the need to report the technique used (open or closed) at facilities or physician’s offices where PRP is prescribed and used.
This information is available at the following sites:
