Marco regulatorio de los medicamentos hemoderivados de uso humano

  1. Victoria Collazo López
  2. Concepción Alonso Verduras
  3. Gloria Frutos Cabanillas
Anales de la Real Academia Nacional de Farmacia

ISSN: 1697-4298 0034-0618

Year of publication: 2015

Volume: 81

Issue: 2

Pages: 103-115

Type: Article

More publications in: Anales de la Real Academia Nacional de Farmacia


A complete review of the regulations applicable to blood derived medicines is made, including European legislation and its transposition into national legislation. This complex and comprehensive regulation is updated and commented to facilitate appropriate guidance to healthcare professionals for its consultation and use. Blood derived products, as chronic medication and susceptible of transmitting diseases, are very important in the pharmaceutical industry, they have a large social and mediatic impact and their manufacturing is based on the use of human plasma as raw material. The discussion on donating plasma altruistically or in remunerated manner and its effect on self-sufficiency for the availability of blood products is also addressed.