1. In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products, Member States shall take the necessary measures to prevent the transmission of infectious diseases. In so far as this is covered by the amendments referred to in Article 121(1), as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors.
2. Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable.
3. All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries.