For biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, the procedures and the criteria of acceptability published as recommendations of the WHO (Requirements for Biological Substances) shall serve as guidelines for all controls of production stages which are not specified in the European Pharmacopoeia, or falling this, in the national pharmacopoeia of a Member State.
Pri bioloških zdravilih, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, se kot smernice za vse nadzore faz proizvodnje, ki niso navedene v Evropski farmakopeji ali farmakopeji države članice, upoštevajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).