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22/03/2021

Six key points about the PRP and its legislation in Spain

Last Friday, 19th of March, we attended the third session of the Biological Therapies Cycle of the Spanish Society of Sports Traumatology (SETRADE, according to the Spanish acronym) given by Dr. Sol Ruiz Antúnez, from the Division of Biological Products, Advanced Therapies and Biotechnology of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).

The session was divided into two parts, one dealing with the PRP and its legislation, which we will analyse in this article, and another one resolving around cell therapies.

In terms of the PRP, six key points that we all need to keep in mind were highlighted:

• According to the Spanish Agency for Medicines and Health Products (AEMPS), Platelet-Rich Plasma (PRP) is considered a medicine for human use that is applied to meet special needs.
• PRP can only be prescribed by doctors, dentists or podiatrists and it cannot be prescribed by any other health or non-health professional.
• The prescribing physician is responsible for ensuring the efficacy and quality of the PRP, as well as for the information provided to the patient.
• There are two types of system for PRP obtention: closed systems and open systems. Closed systems mechanically prevent the transfer of environmental pollutants. The list of authorized closed systems can be found by clicking here.
• Centres opting for an open PRP obtention system have to be assessed by the competent authorities to verify the adequacy of the facilities and PRP production.
• The AEMPS strongly recommends pre-treatment serological testing to ensure both patient and worker safety. In any case, the prescribing doctor is responsible for ensuring the safety of the process.

Find here all the information regarding the AEMPS PRP treatment.